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/