Medical Devices Rules 2017 — India's Risk-Based Regulatory Framework
India's Medical Devices Rules 2017 (MDR 2017), notified under the Drugs and Cosmetics Act 1940, introduced a comprehensive risk-based regulatory framework for medical devices administered by the Central Drugs Standard Control Organisation (CDSCO). Devices are classified as Class A (lowest risk), B, C, or D (highest risk), broadly aligned with the IMDRF/GHTF classification principles.
Key features:
- Import Licence (Form MD-14) required for all Class B, C, D imported medical devices before sale in India.
- Class A import requires a simplified process (Form MD-15/notification) rather than a full licence.
- Indian Authorised Representative (IAR): Foreign manufacturers must appoint an IAR registered with CDSCO who holds the import licence.
- Free Sale Certificate (FSC) and Certificate of Conformity (CoC) from the country of origin required for import applications.
- SUGAM portal: CDSCO's online platform for all medical device applications, status tracking, and communications.
- Manufacturing licence: Issued by State Licensing Authorities (SLAs) against GMP requirements in Schedule 5 of MDR 2017.
📅 Effective / published: 2017; phased implementation (notified device categories expanded in stages through 2023+)
India has significantly expanded the list of notified medical devices requiring registration under MDR 2017. Manufacturers should verify whether their specific device category has been brought under regulatory control and whether transitional timelines apply. CDSCO frequently updates the notified device lists — check the SUGAM portal for the current schedule.
View official source (CDSCO — Medical Devices) ↗