India, 15 December 2025 The Ministry of Health and Family Welfare (MoHFW) has formally published a Draft Notification (G.S.R. 883(E)) proposing significant amendments to the Medical Devices Rules, 2017. The draft was published in the Gazette of India on December 4, 2025. These amendments aim to simplify business operations by introducing perpetual license validity while simultaneously tightening post-market surveillance through stricter testing and reporting standards.
INDIA MEDICAL DEVICE RULES: TIMELINE FOR MANUFACTURERS
The publication of the India Medical Device Rules draft triggers the following timeline for industry feedback and implementation:
- Today (04 DECEMBER 2025): The draft rules are published for public information. The 30-day consultation period begins immediately.
- In 30 Days (03 JANUARY 2026): The deadline for submitting objections and suggestions ends. Feedback must be sent to the Under Secretary (Drugs) via email or post by this date.
- Final Implementation Date: These rules will formally come into force on the date of their final publication in the Official Gazette, following the review of stakeholder feedback.
G.S.R. 883(E): IMPACTED REGULATORY AREAS
The proposed amendments under G.S.R. 883(E) will specifically impact the following areas of compliance and operations:
- License Validity: Manufacturing and import licenses (Forms MD-5, MD-6, MD-9, MD-10, MD-15) and Registration Certificates (Form MD-40) will no longer expire. They will remain valid in perpetuity, provided the license holder deposits the required Retention Fee and the license is not suspended or cancelled.
- Class A Labeling & Documentation: Distinct terminology is introduced for Class A (Non-Sterile and Non-Measuring) devices. Manufacturers must now use “Registration Number” or “Reg. No.” on labels and import documents, distinct from full “License Numbers”.
- Testing & Evaluation (Form MD-44): A new mandatory reporting format, Form MD-44, is introduced. Registration holders must use this form to submit test or evaluation reports, which includes specific fields for batch numbers, raw material details, and test protocols.
- Inspections (Form MD-11): The Inspection Book format is updated to explicitly include “Registration Holders,” ensuring that facilities manufacturing Class A devices are audited under the correct regulatory identity.
- Sampling: New tables are inserted into Forms MD-36, MD-37, and MD-38 to capture granular data (Batch No., Brand Name, Date of Manufacture) during regulatory sampling and seizure.
Guidance & Reference Materials
To help prepare for these changes, manufacturers should review the specific draft text and updated forms:
- Form MD-44 Template: Review the new fields required for test reports.
- Feedback Channel: Submit your comments to [email protected].
- Official Gazette: Review the full text of G.S.R. 883(E).