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

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