2026.06.23 515(E)_Draft notification regarding amendments under Medical Devices Rules 2017

The draft would be called the Medical Devices (Amendment) Rules, 2026. The Central Government will review feedback and recommendations from stakeholders who submits them within the designated 30-day window. The comments can be addressed to Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, C Wing, First Floor, Kartavya Bhavan 1, New Delhi - 110001 or via email at drugsdiv-mohfw@gov.in."   For Class B devices and applications assigned to Notified Bodies, the State Licensing Authority must complete scrutiny within 30 days of online submission. If deficiencies are raised and later remedied, the 30‑day clock restarts from the date deficiencies are removed.   Manufacturing sites must conform to a Quality Management System (QMS) as specified in the Fifth Schedule and applicable standards. QMS conformance must be verified by an audit carried out by a registered Notified Body (as per rule 13) before grant of license.   After assignment to a Notified Body, that body must conduct the site audit in the manner specified in the Third Schedule within 30 days of assignment and submit the audit report to the State Licensing Authority. Where non‑conformances are found during the Notified Body audit, the compliance verification shall be done within 20 days from the date the manufacturer’s compliance report is received by the authority   The Notified Body must furnish its final audit report and recommendations to the State Licensing Authority within 15 days after audit completion. In rule sub-rule (4) in rule 21, the word “forty-five” shall be replaced with the word “thirty” In rule sub-rule (1) in rule 23, the word “sixty” shall be replaced with the word “forty-five” In rule sub-rule (1) in rule 25, the word “forty-five” shall be replaced with the word “twenty” A new sub rule(3), shall be added after sub-rule (2) in rule 23, “In case of non-conformance of Quality Management System requirements as observed during the inspection by the inspection team referred to in sub-rule (1), the compliance verification shall be carried out within fifteen days from the date of receipt of compliance report from manufacturer.”   State Licensing Authorities must process and coordinate faster, including handling Notified Body reports promptly.