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Monday, February 28, 2022
Sunday, February 27, 2022
Download Latest Notifications: General (Pharmaceuticals)
General Notification of e-Cigarettes, e-Pharmacy, Food safety, Haryana Pharmaceutical Policy and Pharmacy Council of India: Govt. of India issues Notifications time to time which are published by Department of Publication and are printed by the Government of India Printing Presses regularly.
We have provided some of the notifications relevant to the above said topic, Click below links for more information:
e-Cigarettes
Ban-on-e-cigarettes-ordinance-2019
e-Pharmacy
Draft-on-e-pharmacy-report
Food safety
2021
FSSAI-dt-16-07-2021-Direction-under-section-165-of-FSS-Act-2006-regarding-RDA-Recommended-Dietary-Allowances
FSSAI-Notification-dt-02-02-2021-on-Food-Safety-and-Standards-Prohibition-and-Restrictions-on-Sales-Second-Amendment-Regulations-2021-relating-to-limits-of-trans-fats-in-Food-Products
FSSAI-Notification-dt-12-01-2021-on-NABL-Accredited-Laboratories-under-section-431-of-FSS-Act
2020
FDA Haryana: Commissioners-order-dt-01-04-2020-Chewing-gum-bubble-gum-banned-in-Haryana-till-30-06-2020
FSSAI-Letter-dt-11-06-2020-Compliance-w.r.t.-RDA-values-for-license-issued-for-Suuplements-Nutraceuticals-etc.
FSSAI-Letter-dt-07-01-2020-Recommended-Dietry-Allowance-RDA-Value-of-Vitamins-Proteins-Fats-Minerals-etc
Indian Pharmacopoeia Commission (IPC)
2021
IPC-Notice-dt-26-07-2021-IP-Addendum-2021-shall-be-effective-from-31-12-2021
IPC-dt-24-06-21-Revised-Draft-General-Chapter-on-Approach-to-Alternative-Microbiological-Methods
IPC-10-03-2021-Omission-of-Monographs-of-Lorcaserin-Hydrochloride-Hemihydrate-and-Lorcaserin-Tablets-from-the-Indian-Pharmacopoeia
IPC-dt-26-02-2021-Clarification-on-Alternative-Methods-in-the-Indian-Pharmacopoeia
IPC-dt-25-02-2021-Amendment-List-08-to-IP-2018
IPC-19-02-2021-Release-of-Guidance-Document-for-Drafting-and-Formatting-of-Monographs-for-Indian-Pharmacopoeia
IPC-dt-12-01-2021-Draft-of-General-Notices-on-Phytopharmaceutical-Drugs
2019
List-of-145-Impurities-Dec-2019
List-of-594-Reference-Substances-Dec-2019
Pharmaceuticals Policy
2021
DoP-dt-25-10-2021-Draft-Policy-to-Catalyze-Research-Development-and-Innovation-in-the-Pharma-MedTech-Sector-in-India
Roadmap-for-inviting-Pharma-Industry-in-the-State-of-Jharkhand
Jharkhand-Pharmaceutical-Policy-2021-Draft
2019
Haryana-Pharmaceuticals-Policy-2019
Pharmacy Council of India
2022
PCI-dt-24-02-2022-Diploma-in-Pharmacy-Exit-Examination-Regulations-2022
2021
PCI-dt-23-09-2021-Syllabus-for-Diploma-Course-in-Pharmacy-under-regulation-7-of-The-Education-Regulation-2020
PCI-Circular-dt-07-09-2021-Starting-of-B.Pharm-Practice-course.
Pharmacy-practice-amend-Regulation-2021
PCI-dt-23-06-2021-Draft-Syllabus-for-Diploma-Course-in-Pharmacy
2020
The-Education-Regulations-2020-for-Diploma-Course-in-Pharmacy-09-10-2020
PCI-circular-dt-30-09-2020-Inclusion-of-one-Elective-Subject-for-skill-packs
PCI-Circular-dt-17-09-2020-Registration-of-students-who-have-undergone-practical-training-at-Pharmacy-Chemist-Druggist-under-ER-91
PCI-circular-dt-09-07-2020-Guidelines-on-Examinations-Internship-Practical-Training
PCI-circular-dt-09-07-2020-Guidelines-on-academic-programs-and-start-of-the-next-academic-session
2019
PCI-Approval-Medical-store-Pharmacy-for-giving-practical-training-to-D-Pharmacy-students
2015
PCI-Clarification-on-Pharmacy-Practice-Regulations-2015
Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
For Notifications on following topics, click below links:
Banned Drugs
Blood Bank / Centre
Cosmetics
COTPA
DPCO / NPPA
Drugs Act
DMROA
EC Act
Homoeopathic
Hospital – RMI
Medical Devices
NDPS Act
New Drugs
Testing Laboratories
https://thehealthmaster.com/2021/07/08/latest-notifications-general-pharmaceuticals/
Download General Notifications
Download General Notification of e-Cigarettes, e-Pharmacy, Food safety, Haryana Pharmaceutical Policy and Pharmacy Council of India: Govt. of India issues Notifications time to time which are published by Department of Publication and are printed by the Government of India Printing Presses regularly.
We have provided
some of the notifications relevant to the above said topic, Click below links
for more information:
e-Cigarettes
2019
Ban-on-e-cigarettes-ordinance-2019
e-Pharmacy
Draft-on-e-pharmacy-report
Environment control
For manufacturing of Bulk drugs / API
GSR-No.-443E-dt-25-06-2021-Environment-Protection-Second-Amendment-Rule-2021
Food safety
2021
FSSAI-dt-16-07-2021-Direction-under-section-165-of-FSS-Act-2006-regarding-RDA-Recommended-Dietary-Allowances
FSSAI-Notification-dt-02-02-2021-on-Food-Safety-and-Standards-Prohibition-and-Restrictions-on-Sales-Second-Amendment-Regulations-2021-relating-to-limits-of-trans-fats-in-Food-Products
FSSAI-Notification-dt-12-01-2021-on-NABL-Accredited-Laboratories-under-section-431-of-FSS-Act
2020
FDA Haryana: Commissioners-order-dt-01-04-2020-Chewing-gum-bubble-gum-banned-in-Haryana-till-30-06-2020
FSSAI-Letter-dt-11-06-2020-Compliance-w.r.t.-RDA-values-for-license-issued-for-Suuplements-Nutraceuticals-etc.
FSSAI-Letter-dt-07-01-2020-Recommended-Dietry-Allowance-RDA-Value-of-Vitamins-Proteins-Fats-Minerals-etc
Indian Pharmacopoeia Commission (IPC)
2021
IPC-dt-16-09-2021-Guidance-document-on-Calibration-of-Gas-Chromatograph
IPC-dt-16-09-2021-Guidance-document-on-Calibration-of-HPLC
IPC-dt-16-09-2021-Guidance-document-on-Compliance-with-Indian-Pharmacopoeia-Standards
IPC-dt-16-09-2021-Guidance-document-on-Good-Documentation-Practices
IPC-dt-16-09-2021-Guidance-document-on-Legal-Status-of-Indian-Pharmacopoeia
IPC-dt-16-09-2021-Guidance-document-on-Process-for-Development-of-Indian-Pharmacopoeia-Monographs
IPC-dt-16-09-2021-Guidance-document-on-Quality-Management-System-in-Testing-Laboratory
IPC-dt-16-09-2021-Guidance-document-on-Validation-of-Analytical-Methods
IPC-Notice-dt-26-07-2021-IP-Addendum-2021-shall-be-effective-from-31-12-2021
IPC-dt-24-06-21-Revised-Draft-General-Chapter-on-Approach-to-Alternative-Microbiological-Methods
IPC-10-03-2021-Omission-of-Monographs-of-Lorcaserin-Hydrochloride-Hemihydrate-and-Lorcaserin-Tablets-from-the-Indian-Pharmacopoeia
IPC-dt-26-02-2021-Clarification-on-Alternative-Methods-in-the-Indian-Pharmacopoeia
IPC-dt-25-02-2021-Amendment-List-08-to-IP-2018
IPC-19-02-2021-Release-of-Guidance-Document-for-Drafting-and-Formatting-of-Monographs-for-Indian-Pharmacopoeia
IPC-dt-12-01-2021-Draft-of-General-Notices-on-Phytopharmaceutical-Drugs
2019
List-of-145-Impurities-Dec-2019
List-of-594-Reference-Substances-Dec-2019
Pharmaceuticals Policy
2021
DoP-dt-25-10-2021-Draft-Policy-to-Catalyze-Research-Development-and-Innovation-in-the-Pharma-MedTech-Sector-in-India
Roadmap-for-inviting-Pharma-Industry-in-the-State-of-Jharkhand
Jharkhand-Pharmaceutical-Policy-2021-Draft
2019
Haryana-Pharmaceuticals-Policy-2019
Pharmacy Council of India
2022
PCI dt 24-02-2022 Diploma in Pharmacy Exit Examination Regulations, 2022
PCI-dt-24-02-2022-Diploma-in-Pharmacy-Exit-Examination-Regulations-2022
2021
PCI dt 23-09-2021 - Syllabus for Diploma Course in Pharmacy - under regulation 7 of The Education Regulation 2020
PCI-dt-23-09-2021-Syllabus-for-Diploma-Course-in-Pharmacy-under-regulation-7-of-The-Education-Regulation-2020
PCI Circular dt 07-09-2021 - Starting of B.Pharm (Practice) course.
PCI-Circular-dt-07-09-2021-Starting-of-B.Pharm-Practice-course.
Pharmacy Practice (amendment) Regulation 2021
Pharmacy-practice-amend-Regulation-2021
PCI dt 23-06-2021 - Draft Syllabus for Diploma Course in Pharmacy
PCI-dt-23-06-2021-Draft-Syllabus-for-Diploma-Course-in-Pharmacy
2020
The Education Regulations, 2020 for Diploma Course in Pharmacy - 09-10-2020
The-Education-Regulations-2020-for-Diploma-Course-in-Pharmacy-09-10-2020
PCI circular dt 30-09-2020 - Inclusion of one Elective Subject for skill packs
PCI-circular-dt-30-09-2020-Inclusion-of-one-Elective-Subject-for-skill-packs
PCI Circular dt 17-09-2020 - Registration of students who have undergone practical training at Pharmacy, Chemist & Druggist under ER-91
PCI-Circular-dt-17-09-2020-Registration-of-students-who-have-undergone-practical-training-at-Pharmacy-Chemist-Druggist-under-ER-91
PCI circular dt 09-07-2020 - Guidelines on Examinations, Internship, Practical Training
PCI-circular-dt-09-07-2020-Guidelines-on-Examinations-Internship-Practical-Training
PCI circular dt 09-07-2020 - Guidelines on academic programs and start of the next academic session
PCI-circular-dt-09-07-2020-Guidelines-on-academic-programs-and-start-of-the-next-academic-session
2019
PCI-Approval-Medical-store-Pharmacy-for-giving-practical-training-to-D-Pharmacy-students
PCI-Approval-Medical-store-Pharmacy-for-giving-practical-training-to-D-Pharmacy-students
2015
PCI-Clarification-on-Pharmacy-Practice-Regulations-2015
PCI-Clarification-on-Pharmacy-Practice-Regulations-2015
For more notifications, click below links
Banned Drugs
Blood Bank / Centre
Cosmetics
COTPA
DPCO / NPPA
Drug Rules
Drugs Act
DMROA
EC Act
General
Homoeopathic
Hospital – RMI
Medical Devices
NDPS Act
New Drugs
Testing Laboratories
https://thehealthmaster.com/notifications/general-notifications/
Download Classifications of Medical Devices
Download Classifications of Medical Devices: Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder.
For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which is already implemented from 01.01.2018
In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the Drugs Controller General (India) (DCGI) classifies the medical devices, based on the intended use, risk associated with the device and other parameters specified in the First Schedule of the Medical Devices Rules-2017
To read / download, click the respective links below:
2022
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to General Hospital under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 09-08-2021 – Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 23-07-2021 – Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 – Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
2020
DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
2019
DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices
DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-Devices
Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Click to read all articles by the Author
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
https://thehealthmaster.com/2021/09/23/classifications-of-medical-devices-under-the-provisions-of-mdr-2017/
Download Circulars - DCGI, Health Ministry, Department of Pharmaceuticals, ICMR
Download latest circulars: Govt of India, DCGI, Health Ministry, ICMR issues notices / circulars time to time for stake holders and the same are uploaded on official websites of above institutions.
We have provided some of the important notices / circulars relevant to the above said topic, Click below links for more information:
Circulars - DCGI / CDSCO
Source of Circulars / Notices / letters: CDSCO website
2022
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI dt 11-11-2021 - List of Notified Bodies registered with CDSCO under MDR-2017
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
DCGI dt 10-12-2021 - List of the certified Medical Device Testing Laboratory under MDR 2017
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI Notice dt 03-11-2021 Regulation of CT scan equipment All Implantable Devices MRI equipment etc. as Drugs with effect from April 1st 2021
DCGI-Notice-dt-03-11-2021-Regulation-of-CT-scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
CDSCO circular dt 27-10-2021 Best Practices for individual users to safeguard against data breaches
CDSCO-circular-dt-27-10-2021-Best-Practices-for-individual-users-to-safeguard-against-data-breaches
DCGI Notice dt 01-10-2021 Module for online processing of applications for registration of BA BE study centres (CT-08)
DCGI-Notice-dt-01-10-2021-Module-for-online-processing-of-applications-for-registration-of-BA-BE-study-centres-CT-08
GCGI dt 28-09-2021 - Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
DCGI dt 21-09-2021 - Guidance Document for Manufacturers, Importers for voluntary mandatory registration of Medical Devices
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to General Hospital under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI Circular 13-09-2021 - Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-13-09-2021-Special-condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Notice 10-09-2021 - Timelines for activities requiring minor and major procedures for cargo clearances at port offices of CDSCO
DCGI-Notice-10-09-2021-Timelines-for-activities-requiring-minor-and-major-procedures-for-cargo-clearances-at-port-offices-of-CDSCO
DCGI Notice 09-09-2021 - Online Application for issuance of Written Confirmation Certificate WCC regarding
DCGI-Notice-09-09-2021-Online-Application-for-issuance-of-Written-Confirmation-Certificate-WCC-regarding
DCGI 07-09-2021 - List of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference
DCGI-07-09-2021-List-of-standards-published-under-Medical-Equipment-and-Hospital-Planning-MHD-of-BIS-as-forwarded-by-BIS-for-ready-reference
DCGI dt 01-09-2021 Manufacturing and marketing of FDC of Tolperisone HCL 150mg + Paracetamol IP 500mg tablet
DCGI-dt-01-09-2021-Manufacturing-and-marketing-of-FDC-of-Tolperisone-HCL-150mg-Paracetamol-IP-500mg-tablet
DCGI Notice dt 27-08-2021 - List of 16 Testing Laboratories for Medical Devices MDTLs
DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI dt 27-08-2021 Procedure for regulation of FDCs declared as rational in respect to 294 FDCs by DTAB which were licensed to manufacture and market by SLA without approval of DCGI
DCGI-dt-27-08-2021-Procedure-for-regulation-of-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI dt 27-08-2021 Procedure for regulation of 19 FDCs declared as rational in respect to 294 FDCs by DTAB which were licensed to manufacture and market by SLA without approval of DCGI
DCGI-dt-27-08-2021-Procedure-for-regulation-of-19-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI dt 27-08-2021 Manufacturing and marketing of certain FDCs as per directions of Honble High Court Maharashtra Nagpur Bench
DCGI-dt-27-08-2021-Manufacturing-and-marketing-of-certain-FDCs-as-per-directions-of-Honble-High-Court-Maharashtra-Nagpur-Bench
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 19-08-2021 - Certain pre 1988 permitted FDCs de novo manufacturing for sale without approval from CLA
DCGI-Notice-dt-19-08-2021-Certain-pre-1988-permitted-FDCs-de-novo-manufacturing-for-sale-without-approval-from-CLA
DCGI Notice dt 09-08-2021 - Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
FAQs on Cosmetics Rules 2020 by Cosmetic division of CDSCO dt 06-08-2021
FAQs-on-Cosmetics-Rules-2020-by-Cosmetic-division-of-CDSCO-dt-06-08-2021
DCGI dt 02-08-2021 - Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019
DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019
DCGI dt 26-07-2021 - Inviting Public comments, as steps are being taken by CDSCO to regulate the products like skin patches which are being used as cosmetic
DCGI-dt-26-07-2021-Inviting-Public-comments-as-steps-are-being-taken-by-CDSCO-to-regulate-the-products-like-skin-patches-which-are-being-used-as-cosmetic
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 26-07-2021 - Evaluation of certain Pre 1988 permitted FDCs - without due approval from CLA
DCGI-Notice-dt-26-07-2021-Evaluation-of-certain-Pre-1988-permitted-FDCs-without-due-approval-from-CLA
DCGI Circular 23-07-2021 Already approved drugs is New Drug, if certain changes occur in Active substance
DCGI-Circular-23-07-2021-Already-approved-drugs-is-New-Drug-if-certain-changes-occur-in-Active-substance
DCGI Notice dt 23-07-2021 - Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 - Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
DCGI Notice dt 07-07-21 to Stakeholders for Module for online processing of applications for issuance of written Confirmation Certificate (WCC)
DCGI-Notice-dt-07-07-21-to-Stakeholders-for-Module-for-online-processing-of-applications-for-issuance-of-written-Confirmation-Certificate-WCC
CDSCO dt 07-07-2021 - List of 14 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO dt 30-06-2021 - Medical Devices alert for Ventilator of Philips June 2021
CDSCO-dt-30-06-2021-Medical-Devices-alert-for-Ventilator-of-Philips-June-2021
CDSCO notification 25-06-21 - appointment of 172 Medical Devices officers
CDSCO-notification-25-06-21-appointment-of-172-Medical-Devices-officers
DCGI dt 16-05-2021 Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings
DCGI-dt-16-05-2021-Advisory-regarding-Oxygen-Concentrators-suitable-for-COVID-19-case-management-in-Home-settings
DCGI Order 18-04-2021 Regulation of CT Scan equipment, All Implantable Devices, MRI equipment, PET equipment, MRI equipment, X-Ray machine, Defibrillators and Bone marrow cell separator as Drugs with effect from April 1st 2021
DCGI-Order-18-04-2021-Regulation-of-CT-Scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
DCGI Notice dt 15-04-2021 Regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK HRA, PMDA Japan or which are listed in WHO Emergency list
DCGI-Notice-dt-15-04-2021-Regarding-Guidance-for-approval-Covid-19-vaccine-in-India-for-restricted-use-in-emergency-situation-which-are-already-approved-for-restricted-use-by-US-FDA-EMA-UK-HRA-PMDA-Japan-or-which-are-listed-in-WHO-Emergency list
DCGI Circular dt 13-04-2021 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-dt-13-04-2021-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Notice dt 13-04-2021 Submission of notarized or apostilled documents for import and Registration of cosmetics in view of COVID 19
DCGI-Notice-dt-13-04-2021-Submission-of-notarized-or-apostilled-documents-for-import-and-Registration-of-cosmetics-in-view-of-COVID-19
DCGI Notice dt 12-04-2021 Public notice hearing on irrational FDCs which meeting to be held from 19.04.2021 to 07.05.2021 by DTAB Subcommittee
DCGI-Notice-dt-12-04-2021-Public-notice-hearing-on-irrational-FDCs-which-meeting-to-be-held-from-19.04.2021-to-07.05.2021-by-DTAB-Subcommittee
CDSCO dt 08-03-2021 - List of 11 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI Notice dt 25-02-2021 -Regarding implementation of SUGAM Online system for reporting of SAE's
DCGI-Notice-dt-25-02-2021-Regarding-implementation-of-SUGAM-Online-system-for-reporting-of-SAEs
DCGI letter dt 08-02-2021 - Supreme Court decision Cr Appeal No 200-2020 for Cognizable offences
DCGI-letter-dt-08-02-2021-Supreme-Court-decision-Cr-Appeal-No-200-2020-for-Cognizable-offences
2020
DCGI Order dt 28-12-2020 - Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021
DCGI-Order-dt-28-12-2020-Regulation-of-Blood-Glucose-monitors-Blood-pressure-monitors-Nebulizers-and-Thermometers-as-drugs-with-effect-from-Jan-1st-2021
DCGI Circular dt 18-12-2020 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-dt-18-12-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Letter dt 04-12-2020 - Clarification regarding reference standards
DCGI-Letter-dt-04-12-2020-Clarification-regarding-reference-standards
CDSCO dt 09-10-2020 - List of 10 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI Notice dt 17-9-2020 - regarding import of drug & related product
DCGI-Notice-dt-17-9-2020-regarding-import-of-drug-related-product
DCGI Circular 08-09-2020 - regarding 294 rational FDCs - procedure to be followed
DCGI-Circular-08-09-2020-regarding-294-rational-FDCs-procedure-to-be-followed
DCGI Notice dt 03-09-2020 - Classification 24 categories of MD - reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 03-09-2020 - Classification of 3 Categories of MD IVDs - reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt. 31-08-2020 - requirement of fees for change in address of authorized agent under MDR 2017
DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-of-authorized-agent-under-MDR-2017
DCGI Notice dt 31-08-2020 - Submission of notarized documents for import of medical devices and In-Vitro kits in view of Covid-19
DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-for-import-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19
DCGI Circular dt 10-07-2020 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-dt-10-07-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Letter 01-05-2020 - regarding extension of validity of WHO-GMP / CoPP
DCGI-Letter-01-05-2020-Extension-of-validity-of-WHO-GMP-CoPP
DCGI Circular 30-04-2020 - regarding extension of validity of BA/BE study centres
DCGI-Circular-30-04-2020-Extension-of-validity-of-BA-BE-study-centres
DCGI approval 17-04-2020 - Rapid, CLIA, ELISA kits approved for testing of Covid-19 with the condition
DCGI-approval-17-04-2020-Rapid-CLIA-ELISA-kits-approved-for-testing-of-Covid-19-with-the-condition
DCGI Notice 17-04-20 Clinical trial of convalescent plasma in COVID-19 Patients
DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19-Patients
DCGI letter 16-04-20 along with list of 55 critical medicines for Covid-19
DCGI-letter-16-04-20-along-with-list-of-55-critical-medicines-for-Covid-19
DCGI letter 07-04-2020 Regarding granting permission to-manufacture Medical gas by Industrial gases plant
DCGI-letter-07-04-2020-Regarding-granting-permission-to-mafr-Medical-gas-by-Industrial-gases-plant
ICMR-Press-release-17-03-2020-ICMR-enables-more-laboratories-to-test-for-COVID-19-and-revises-the-criteria
DCGI Notice 13-03-20 - Guidelines for approval of synthetically manufactured drugs which has been previously approved as r-DNA derived drug
DCGI-Notice-13-03-20-Guidelines-for-approval-of-synthetically-manufactured-drugs
DCGI Notice 13-03-20 - Requirement of CMC documents for approval of additional indication of an already approved drug product
DCGI-Notice-13-03-20-Requirement-of-CMC-documents-for-approval-of-additional-indication-of-an-already-approved-drug-product
DCGI Notice 13-03-20 - Requirement of process validation report for permission to conduct Clinical trial / BA-BE studies
DCGI-Notice-13-03-20-Requirement-of-process-validation-report-for-permission-to-conduct-Clinical-trial-BA-BE-studies
DCGI Notice 13-03-20 - Testing of all categories of new drugs for their approval
DCGI-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-their-approval
DCGI has issued circular on 04-03-2020 Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2) (b) of Directive No. 2001/83/EC.
DCGI Circular 04-03-2020 – Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU
DCGI has issued circular on 03-03-2020 regarding disposal applications of WHO-GMP, Certificate of Pharmaceutical Products (CoPP)
DCGI-Circular-03-03-2020-Regarding-Disposal-of-applications-of-WHO-GMP-CoPP
DCGI
https://thehealthmaster.com/circulars-on-pharmaceuticals/
Download Classifications of Medical Devices
Download Classifications of Medical Devices: Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder.
For the regulation of medical devices with respect to the import, manufacture, sale and distribution, clinical investigation, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 vide G.S.R. 78 (E) dated 31.01.2017 which is already implemented from 01.01.2018
In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the Drugs Controller General (India) (DCGI) classifies the medical devices, based on the intended use, risk associated with the device and other parameters specified in the First Schedule of the Medical Devices Rules-2017
To read / download, click the respective links below:
2022
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI dt 11-11-2021 - List of Notified Bodies registered with CDSCO under MDR-2017
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
DCGI dt 10-12-2021 - List of the certified Medical Device Testing Laboratory under MDR 2017
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI Notice dt 03-11-2021 Regulation of CT scan equipment All Implantable Devices MRI equipment etc. as Drugs with effect from April 1st 2021
DCGI-Notice-dt-03-11-2021-Regulation-of-CT-scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
CDSCO circular dt 27-10-2021 Best Practices for individual users to safeguard against data breaches
CDSCO-circular-dt-27-10-2021-Best-Practices-for-individual-users-to-safeguard-against-data-breaches
DCGI Notice dt 01-10-2021 Module for online processing of applications for registration of BA BE study centres (CT-08)
DCGI-Notice-dt-01-10-2021-Module-for-online-processing-of-applications-for-registration-of-BA-BE-study-centres-CT-08
GCGI dt 28-09-2021 - Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
DCGI dt 21-09-2021 - Guidance Document for Manufacturers, Importers for voluntary mandatory registration of Medical Devices
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to General Hospital under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 09-08-2021 – Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 23-07-2021 – Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 – Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
2020
DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
2019
DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices
DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-Devices
Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Click to read all articles by the Author
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
https://thehealthmaster.com/2021/09/23/classifications-of-medical-devices-under-the-provisions-of-mdr-2017/
Medical devices - Manufacturing license
In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
Must read articles, click below links:
NPPA-OM-dt-30-09-2021-increase-in-GST-rate-Medical-Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
19 Medical devices added in Public Procurement Policy
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs – on Drug Permission in Brand or Generic Name
FAQs on Sanitizer, N95 Mask & Digital Thermometer
FAQs on Medical Devices Rules, 2017
Understanding Quality Risk Management
Importance of patent regime in pharma industry
IVD (In Vitro Diagnostics)
- In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules- The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
- In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:- Low risk - Class A;
- Low moderate risk- Class B;
- Moderate high risk- Class C;
- High risk- Class D.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
- The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:- Import of all Classes of In Vitro Diagnostic Medical Device
- Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
- Clinical Performance evaluation and approval of new in vitro diagnostic medical devices
- Co-ordination with the State Licensing Authorities
- The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-- Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices
- Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.
How to obtain manufacturing license for Medical Devices
Documents required
For obtaining manufacturing
license for Medical Devices, the list of documents required is provided below. Download
the pdf file and prepare the documents accordingly.
Documents-required-for-obtaining-Mfg-license-for-Medical-Devices
Procedure
Procedure for obtaining
manufacturing license for Medical Devices. Download the pdf file for more
detail and prepare the documents accordingly.
Procedure-for-obtaining-Mfg-license-for-Medical-Devices
Forms
List of Form MD 1 to MD 40 of Medical Devices, click below link to read or download the desired Form:
Medical-Devives-Form-MD-1-to-MD-40
Click for all other application forms
Sugam Portal
Submit your
application (Online at SUGAM Portal) after completing all the required
documents. Click the link below for SUGAM Portal:
SUGAM Portal
Note:
Requirements of some of documents and procedure for submission of application
may vary from State to State
License retention fee
Procedure for
submission of license retention fee. Download the pdf file for more detail and
prepare the documents accordingly.
Procedure-for-License-retention-fee
Medical Device Testing Laboratories (MDTLs)
Central Govt. time to time notifies Medical Devices Testing Laboratories. For more details click below links:
List of MDTLs
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs
List of Notified bodies
Central Govt. has notified 8 Notified Bodies on 30-12-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:
List-of-notified-bodies-8-as-on-30-12-2019
Central Govt.
has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of
manufacturing of Medical Devices Category B. For more details click below:
List-of-Notified-bodies-6-as-on-31-07-2019
Medical Devices
have been divided into four categories i.e. A, B C & D. For more details of
classification of Medical Devices dated 15-05-2019, click below:
Medical Devices Categories / Classification
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 09-08-2021 – Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 23-07-2021 – Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 – Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices
DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-Devices
MRPs of Medical Devices
NPPA Office Memorandum dt 23-07-2021 – for Revised MRPs in pursuance to the TMR Notification for 5 Medical Devices
NPPA-Office-Memorandum-dt-23-07-2021-–-for-Revised-MRPs-in-pursuance-to-the-TMR-Notification-for-5-Medical-Devices
NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices
NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices
NPPA Dt 09-06-2021 – Office Memorandum -Revised MRP for Oxygen Concentrators
NPPA-Dt-09-06-2021-Office-Memorandum-Revised-MRP-for-Oxygen-Concentrators
NPPA Office Memorandum dt 04-06-2021 In pursuance to the Notification dated 03.06.2021 for Oxygen Concentrators
NPPA-Office-Memorandum-dt-04-06-2021-In-pursuance-to-the-Notification-dated-03.06.2021-for-Oxygen-Concentrators
NPPA order dt 03-06-2021 Price Cap for Oxygen Concentrator through Trade Margin Rationalisation Approach
NPPA-order-dt-03-06-2021-Price-Cap-for-Oxygen-Concentrator-through-Trade-Margin-Rationalisation-Approach
NPPA Office Memorandum dt 15-05-2021 for call of MRP Data for Pulse Oximeter & Oxygen Concentrator 2021
NPPA-Office-Memorandum-dt-15-05-2021-for-call-of-MRP-Data-for-Pulse-Oximeter-Oxygen-Concentrator-2021
Bureau of Indian Standards (BIS) of Medical Devices
Bureau of Indian Standards (BIS) of Medical Devices, click below link:
DoP-Notice-dt-01-02-2022-List-of-standards-of-Bureau-of-Indian-Standards-BIS-for-Medical-Devices
Fifth Schedule QMS
Medical Devices
manufacturing units have to maintain the facilities as per Fifth Schedule,
Quality Management System for medical devices and in vitro diagnostic medical devices. For more details, click below:
Medical-Devices-Fifth-Schedule-QMS
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL for Medical Devices
Click below link for more details:
NABL
NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices
NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices
DCGI Notice dt. 31-08-2020 – requirement of fees for change in address of authorized agent under MDR 2017
DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-of-authorized-agent-under-MDR-2017
DCGI Notice dt 31-08-2020 – Submission of notarized documents for import of medical devices and In-Vitro kits in view of Covid-19
DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-for-import-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19
Additional information for Medical Devices
For additional information
for Medical Devices, click below:
Additional-information-MDR-2017
Medical Devices Rule 2017
To download Medical Devices Rule 2017, click below
Medical-Device-Rules-2017
Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
Guidelines on registration of Medical Store
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
Medical Device Notifications
For various notifications of medical devices, click below link:
Notifications - Medical Devices
Notifications – Drugs Act
Notifications – Drugs Rule
Click here for more articles on Medical Devices
https://thehealthmaster.com/2021/07/15/procedure-to-obtain-license-for-manufacturing-of-medical-devices/
Procedure to obtain Medical devices - Manufacturing license
In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
Must read articles, click below links:
NPPA-OM-dt-30-09-2021-increase-in-GST-rate-Medical-Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
19 Medical devices added in Public Procurement Policy
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs – on Drug Permission in Brand or Generic Name
FAQs on Sanitizer, N95 Mask & Digital Thermometer
FAQs on Medical Devices Rules, 2017
Understanding Quality Risk Management
Importance of patent regime in pharma industry
IVD (In Vitro Diagnostics)
- In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules- The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
- In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:- Low risk - Class A;
- Low moderate risk- Class B;
- Moderate high risk- Class C;
- High risk- Class D.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
- The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:- Import of all Classes of In Vitro Diagnostic Medical Device
- Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
- Clinical Performance evaluation and approval of new in vitro diagnostic medical devices
- Co-ordination with the State Licensing Authorities
- The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-- Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices
- Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.
How to obtain manufacturing license for Medical Devices
Documents required
For obtaining manufacturing
license for Medical Devices, the list of documents required is provided below. Download
the pdf file and prepare the documents accordingly.
Documents-required-for-obtaining-Mfg-license-for-Medical-Devices
Procedure
Procedure for obtaining
manufacturing license for Medical Devices. Download the pdf file for more
detail and prepare the documents accordingly.
Procedure-for-obtaining-Mfg-license-for-Medical-Devices
Forms
List of Form MD 1 to MD 40 of Medical Devices, click below link to read or download the desired Form:
Medical-Devives-Form-MD-1-to-MD-40
Click for all other application forms
Sugam Portal
Submit your
application (Online at SUGAM Portal) after completing all the required
documents. Click the link below for SUGAM Portal:
SUGAM Portal
Note:
Requirements of some of documents and procedure for submission of application
may vary from State to State
License retention fee
Procedure for
submission of license retention fee. Download the pdf file for more detail and
prepare the documents accordingly.
Procedure-for-License-retention-fee
Medical Device Testing Laboratories (MDTLs)
Central Govt. time to time notifies Medical Devices Testing Laboratories. For more details click below links:
List of MDTLs
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs
List of Notified bodies
DCGI dt 11-11-2021 – List of Notified Bodies registered with CDSCO under MDR-2017
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
Central Govt. has notified 8 Notified Bodies on 30-12-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:
List-of-notified-bodies-8-as-on-30-12-2019
Central Govt.
has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of
manufacturing of Medical Devices Category B. For more details click below:
List-of-Notified-bodies-6-as-on-31-07-2019
Medical Devices
have been divided into four categories i.e. A, B C & D. For more details of
classification of Medical Devices dated 15-05-2019, click below:
Medical Devices Categories / Classification
2022
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 – Classification of Medical Device pertaining to General Hospital under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 09-08-2021 – Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 – Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 – Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 23-07-2021 – Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 – Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
2020
DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
2019
DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices
DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-Devices
MRPs of Medical Devices
NPPA Office Memorandum dt 23-07-2021 – for Revised MRPs in pursuance to the TMR Notification for 5 Medical Devices
NPPA-Office-Memorandum-dt-23-07-2021-–-for-Revised-MRPs-in-pursuance-to-the-TMR-Notification-for-5-Medical-Devices
NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices
NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices
NPPA Dt 09-06-2021 – Office Memorandum -Revised MRP for Oxygen Concentrators
NPPA-Dt-09-06-2021-Office-Memorandum-Revised-MRP-for-Oxygen-Concentrators
NPPA Office Memorandum dt 04-06-2021 In pursuance to the Notification dated 03.06.2021 for Oxygen Concentrators
NPPA-Office-Memorandum-dt-04-06-2021-In-pursuance-to-the-Notification-dated-03.06.2021-for-Oxygen-Concentrators
NPPA order dt 03-06-2021 Price Cap for Oxygen Concentrator through Trade Margin Rationalisation Approach
NPPA-order-dt-03-06-2021-Price-Cap-for-Oxygen-Concentrator-through-Trade-Margin-Rationalisation-Approach
NPPA Office Memorandum dt 15-05-2021 for call of MRP Data for Pulse Oximeter & Oxygen Concentrator 2021
NPPA-Office-Memorandum-dt-15-05-2021-for-call-of-MRP-Data-for-Pulse-Oximeter-Oxygen-Concentrator-2021
Bureau of Indian Standards (BIS) of Medical Devices
Bureau of Indian Standards (BIS) of Medical Devices, click below link:
DoP-Notice-dt-01-02-2022-List-of-standards-of-Bureau-of-Indian-Standards-BIS-for-Medical-Devices
Fifth Schedule QMS
Medical Devices
manufacturing units have to maintain the facilities as per Fifth Schedule,
Quality Management System for medical devices and in vitro diagnostic medical devices. For more details, click below:
Medical-Devices-Fifth-Schedule-QMS
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL for Medical Devices
Click below link for more details:
NABL
NPPA S.O. 2808 dt 13-07-2021 – Trade Margin Rationalisation (TMR) of 5 Medical Devices
NPPA-S.O.-2808-dt-13-07-2021-Trade-Margin-Rationalisation-TMR-of-5-Medical-Devices
DCGI Notice dt. 31-08-2020 – requirement of fees for change in address of authorized agent under MDR 2017
DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-of-authorized-agent-under-MDR-2017
DCGI Notice dt 31-08-2020 – Submission of notarized documents for import of medical devices and In-Vitro kits in view of Covid-19
DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-for-import-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19
Additional information for Medical Devices
For additional information
for Medical Devices, click below:
Additional-information-MDR-2017
Medical Devices Rule 2017
To download Medical Devices Rule 2017, click below
Medical-Device-Rules-2017
Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
Guidelines on registration of Medical Devices
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
Medical Device Notifications
For various notifications of medical devices, click below link:
Notifications - Medical Devices
Notifications – Drugs Act
Notifications – Drugs Rule
Click here for more articles on Medical Devices
https://thehealthmaster.com/drugs/manufacturing-licenses/medical-devices-manufacturing-license/
Download latest Circulars – CDSCO, DCGI
Download latest circulars: Govt of India, DCGI, Health Ministry, ICMR issues notices / circulars time to time for stake holders and the same are uploaded on official websites of above institutions.
We have provided some of the important notices / circulars relevant to the above said topic, Click below links for more information:
Circulars – CDSCO, DCGI
Source of Circulars / Notices / letters: CDSCO website
2022
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI-Notice-dt-03-11-2021-Regulation-of-CT-scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
CDSCO-circular-dt-27-10-2021-Best-Practices-for-individual-users-to-safeguard-against-data-breaches
DCGI-Notice-dt-01-10-2021-Module-for-online-processing-of-applications-for-registration-of-BA-BE-study-centres-CT-08
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI-Circular-13-09-2021-Special-condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI-Notice-10-09-2021-Timelines-for-activities-requiring-minor-and-major-procedures-for-cargo-clearances-at-port-offices-of-CDSCO
DCGI-Notice-09-09-2021-Online-Application-for-issuance-of-Written-Confirmation-Certificate-WCC-regarding
DCGI-07-09-2021-List-of-standards-published-under-Medical-Equipment-and-Hospital-Planning-MHD-of-BIS-as-forwarded-by-BIS-for-ready-reference
DCGI-dt-01-09-2021-Manufacturing-and-marketing-of-FDC-of-Tolperisone-HCL-150mg-Paracetamol-IP-500mg-tablet
DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI-dt-27-08-2021-Procedure-for-regulation-of-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI-dt-27-08-2021-Procedure-for-regulation-of-19-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI-dt-27-08-2021-Manufacturing-and-marketing-of-certain-FDCs-as-per-directions-of-Honble-High-Court-Maharashtra-Nagpur-Bench
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI-Notice-dt-19-08-2021-Certain-pre-1988-permitted-FDCs-de-novo-manufacturing-for-sale-without-approval-from-CLA
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
FAQs-on-Cosmetics-Rules-2020-by-Cosmetic-division-of-CDSCO-dt-06-08-2021
DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019
DCGI-dt-26-07-2021-Inviting-Public-comments-as-steps-are-being-taken-by-CDSCO-to-regulate-the-products-like-skin-patches-which-are-being-used-as-cosmetic
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI-Notice-dt-26-07-2021-Evaluation-of-certain-Pre-1988-permitted-FDCs-without-due-approval-from-CLA
DCGI-Circular-23-07-2021-Already-approved-drugs-is-New-Drug-if-certain-changes-occur-in-Active-substance
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
DCGI-Notice-dt-07-07-21-to-Stakeholders-for-Module-for-online-processing-of-applications-for-issuance-of-written-Confirmation-Certificate-WCC
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-dt-30-06-2021-Medical-Devices-alert-for-Ventilator-of-Philips-June-2021
CDSCO-notification-25-06-21-appointment-of-172-Medical-Devices-officers
DCGI-dt-16-05-2021-Advisory-regarding-Oxygen-Concentrators-suitable-for-COVID-19-case-management-in-Home-settings
DCGI-Order-18-04-2021-Regulation-of-CT-Scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
DCGI-Notice-dt-15-04-2021-Regarding-Guidance-for-approval-Covid-19-vaccine-in-India-for-restricted-use-in-emergency-situation-which-are-already-approved-for-restricted-use-by-US-FDA-EMA-UK-HRA-PMDA-Japan-or-which-are-listed-in-WHO-Emergency list
DCGI-Circular-dt-13-04-2021-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI-Notice-dt-13-04-2021-Submission-of-notarized-or-apostilled-documents-for-import-and-Registration-of-cosmetics-in-view-of-COVID-19
DCGI-Notice-dt-12-04-2021-Public-notice-hearing-on-irrational-FDCs-which-meeting-to-be-held-from-19.04.2021-to-07.05.2021-by-DTAB-Subcommittee
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI-Notice-dt-25-02-2021-Regarding-implementation-of-SUGAM-Online-system-for-reporting-of-SAEs
DCGI-letter-dt-08-02-2021-Supreme-Court-decision-Cr-Appeal-No-200-2020-for-Cognizable-offences
2020
DCGI-Order-dt-28-12-2020-Regulation-of-Blood-Glucose-monitors-Blood-pressure-monitors-Nebulizers-and-Thermometers-as-drugs-with-effect-from-Jan-1st-2021
DCGI-Circular-dt-18-12-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI-Letter-dt-04-12-2020-Clarification-regarding-reference-standards
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI-Notice-dt-17-9-2020-regarding-import-of-drug-related-productFor daily updates on mail, subscribe below
DCGI-Circular-08-09-2020-regarding-294-rational-FDCs-procedure-to-be-followed
DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020
DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-of-authorized-agent-under-MDR-2017
DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-for-import-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19
DCGI-Circular-dt-10-07-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI-Letter-01-05-2020-Extension-of-validity-of-WHO-GMP-CoPP
DCGI-Circular-30-04-2020-Extension-of-validity-of-BA-BE-study-centres
DCGI-approval-17-04-2020-Rapid-CLIA-ELISA-kits-approved-for-testing-of-Covid-19-with-the-condition
DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19-Patients
DCGI-letter-16-04-20-along-with-list-of-55-critical-medicines-for-Covid-19
DCGI-letter-07-04-2020-Regarding-granting-permission-to-mafr-Medical-gas-by-Industrial-gases-plant
ICMR-Press-release-17-03-2020-ICMR-enables-more-laboratories-to-test-for-COVID-19-and-revises-the-criteria
DCGI-Notice-13-03-20-Guidelines-for-approval-of-synthetically-manufactured-drugs
DCGI-Notice-13-03-20-Requirement-of-CMC-documents-for-approval-of-additional-indication-of-an-already-approved-drug-product
DCGI-Notice-13-03-20-Requirement-of-process-validation-report-for-permission-to-conduct-Clinical-trial-BA-BE-studies
DCGI-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-their-approval
DCGI Circular 04-03-2020 – Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU
DCGI-Circular-03-03-2020-Regarding-Disposal-of-applications-of-WHO-GMP-CoPP
DCGI-Notice-26-02-2020-Submission-and-processing-of-application-for-registration-certificate-and-import-license-in-parallel-with-new-drug-application
DCGI-Notice-21-02-2020-regarding-approval-of-FDCs-containing-new-drugs
DCGI-Notice-21-02-2020-regarding-fixing-of-limit-of-impurities-in-the-specifications-of-INDs
DCGI-Notice-21-02-2020-regarding-permission-to-conduct-BA-BE-studies-and-clinical-trial
DCGI-Notice-21-02-2020-regarding-pre-submission-meeting-for-new-drugs-and-clinical-trials
DCGI-Notice-21-02-2020-regarding-Processing-of-application-for-BA-BE-permission-issued-in-Form-CT-07-import-license-issued-in-CT-17
DCGI-Notice-21-02-2020-regarding-requirements-of-stability-data-for-CoPPs
DCGI-Notice-21-02-2020-regarding-stability-data-for-BA-BE-study-in-human-for-export
DCGI-Notice-21-02-2020-regarding-sub-acute-toxicity-study-report-for-injectable-products-for-BA-BE-study-in-human-for-export
DCGI-Notice-20-02-2020-Considerations-of-Honble-Supremen-Court-of-India-in-the-case-of-294-FDCs
DCGI-Notice-07-02-2020-Pathway-for-subsequent-manufacture-of-category-d-FDCs-as-per-Prof.-Kokate-Committee-Report-extension-in-time-limit-for-submission-of-application
DCGI-Notice-27-01-2020-Processing-of-post-approval-to-BA-BE-permission-issued-in-Form-CT-07-import-license-issued-in-CT-17
DCGI-Notice-22-01-2020-List-of-Reference-Products-for-Conduct-of-BE-Study
2019
DCGI-Notice-dt-15-12-2019-Regarding-warning-of-Schedule-H-H1-and-X-drugs
DCGI-Notice-08-11-2019-Clarification-on-exemption-of-sale-license-for-importer-of-X-Ray-MRI-PET-Ultrasound-CT-Scan-machine-etc.
DCGI-Notice-08-11-2019-Clarification-on-Implantable-Medical-Devices
DCGI-Notice-08-11-2019-Clarification-regarding-environmental-conditions-for-equipments
CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO-DBT-and-ICMR-Joint-Guidelines-October-2019-for-Evaluation-of-Nanopharmaceuticals-in-India
DCGI-Circular-05-07-2019-Monitoring-the-end-use-of-drugs-which-are-meant-for-dual-use
DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-Devices
CDSCO / DCGI Guidelines
We have provided some of the important CDSCO / DCGI Guidelines, Click below links for more information:
Recall & Rapid Alert System
CDSCO-Guideline-on-Recall-and-Rapid-Alert-System-for-drugs-including-Biologicals-vaccines-version-2017
CDSCO-Guidelines-on-Recall-and-Rapid-Alert-System-for-Drugs
Good Distribution Practice
DCGI-Notice-25-09-2018-Draft-Guidelines-on-Good-Distribution-Practices-for-Pharmaceutical-Products
CDSCO-Guidelines-on-Good-Distribution-Practices-for-Biological-Products
Samples declared as Spurious / NSQ
CDSCO-Guidelines-for-taking-action-on-samples-declared-as-Spurious-or-NSQ
Also read latest notifications on:
Banned Drugs
Blood Bank / Centre
Cosmetics
COTPA
DPCO / NPPA
Drug Rules
Drugs Act
DMROA
EC Act
General
Homoeopathic
Hospital – RMI
Medical Devices
NDPS Act
New Drugs
Testing Laboratories
https://thehealthmaster.com/2021/04/18/latest-circulars-notices-guidelines-cdsco-dcgi/
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