Date of Publication: 10-Apr-2026
INTELLIGENCE OVERVIEW
Agency: Official Gazette of India/MHFW
The Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017 on 10 April 2026, inviting feedback from stakeholders and the public.
The proposed changes aim to strengthen regulatory requirements, particularly by introducing Quality Management System (QMS) compliance alongside existing standards under key provisions (Rules 19H and 19J). This move highlights the government’s focus on improving the quality and safety framework for medical devices in India.
Stakeholders are invited to submit comments and suggestions within 30 days from the date of publication. All feedback will be considered before finalizing the amendments.
KEYWORDS: Quality Management System, Testing Laboratories, Public Consultation
REFERENCE: https://egazette.gov.in/(S(saaxmjnwuwwi4c3y0layi5za))/ViewPDF.aspx