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The Medical Devices Rules 2017 (MDR 2017) (Amended by GSR 777(E) dated 14-Oct-2022). The Medical Devices Rule 2017 (“MDR 2017”) is the primary legislation governing the manufacture, import and sale of medical devices in India under the Drugs and Cosmetics Act, 1940. It regulates the classification of medical devices (Class A to D), licenses, quality control, labelling, post-approval changes and clinical investigation of medical devices among other things.

CDSCO internal targeted timeline document dated 20-Feb-2020 for application processing. For medical devices: Import Licence MD-15 – 270 working days, Test Licence MD-13/MD-17 – 30 days, permission for clinical investigation MD-23/MD-25 – 90 days, Class A/B manufacturing licence – 45-120 days, Class C/D manufacturing licence – 45-60 days, post-approval changes – 45-60 days.

Gazette notification GSR 19(E) dated 18-Jan-2022 amending Rules 19B, 19C, 19D and 19E of MDR 2017. This notification allows an applicant who has submitted an undertaking as on 28 th Feb 2022 to apply for ISO 13485 certification by 31 st May 2022 in lieu of a compliance certificate. The applicant is issued a provisional registration number valid till May 2022.

CDSCO guidance CDSCO/MD/GD/RC/01/00 for registration of medical devices in India: common submission format for notified-device registration/re-registration under the Drugs and Cosmetics Act - Form 40, POA, FSC, ISO 13485/CE QMS, audit reports, Schedule D-I (Plant/Site Master File) and Schedule D-II Device Master File CDSCO technical dossier.

Building or registering software as a medical device in India under CDSCO July 2026 update – MDR 2017 finally addresses software as medical devices: SaMD versus SiMD classification, IEC 62304 lifecycle management, and post-market control for algorithm updates and cybersecurity to ensure what to file, how to classify the risk, and what to prove after launch.

CDSCO Form MD-14 / MD 14 form is basically the MDR 2017 Import Licence Dossier for Class B, C and D devices. The mandatory documents to be attached along with the application are covering letter, apostilled POA, wholesale or manufacturing licence, FSC/Audit reports, ISO 13485/CE QMS certificates, Plant & Device Master Files (Fourth Schedule), overseas plant registration, constitution and fee challan for fresh and endorsement applications.