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 dt 28-04-2022 Procedure for regulation of FDCs with respect to 294 FDCs DCGI-dt-28-04-2022-Procedure-for-regulation-of-FDCs-with-respect-to-294-FDCs 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)
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