Medical Devices Rules Amended to Include European Union Countries in Rule 63

The Ministry of Health and Family Welfare has notified the Medical Devices (Third Amendment) Rules, 2026, further amending the Medical Devices Rules, 2017.

Key points include:

1. Amends Rule 19H to require compliance with standards and Quality Management System under the specified provision.
2. Similarly amends Rule 19J to include Quality Management System alongside existing standards.
3. Changes the marginal heading of Rule 19 to “Government Medical Device Testing laboratories”.
4. Amends Rule 63 to include European Union countries alongside the countries already specified under the provision.
5. The amendment follows consideration of objections and suggestions received on the draft rules published on 10 April 2026.
6. The Medical Devices (Third Amendment) Rules, 2026 come into force from the date of their final publication in the Official Gazette, unless otherwise specified.
7. The amendments strengthen quality management and expand the countries recognised under the specified Rule 63 provision.