Phased expansion of notified medical device categories requiring CDSCO registration
Key Date
2026-10-01 — Phased expansion of notified medical device categories requiring CDSCO registration
India's MDR 2017 framework uses a phased notification approach — medical device categories are progressively brought under mandatory CDSCO regulation by Gazette notification. Devices not yet notified can be imported and sold without a licence (subject to other applicable laws), but once a category is notified, the MDR 2017 registration requirements apply.
Manufacturers supplying India must:
- Confirm whether their specific device category is currently on the notified list (Schedules to MDR 2017 and subsequent amendment notifications).
- If recently notified, comply within the applicable transition period specified in the notification.
- If not yet notified, monitor the CDSCO website and Gazette of India for upcoming notifications affecting your device category.
The CDSCO and Ministry of Health and Family Welfare issue updated device category notifications periodically. Verify the current notification status of your device category directly with CDSCO or your Indian Authorised Representative (IAR).
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