Nov 4, 2021

India’s Ministry of Health and Family Welfare has proposed easing medical device registration requirements related to proof of ISO 13485 quality management system (QMS) certification.

A draft amendment issued by the ministry targets requirements under Chapter IIIA of India’s Medical Device Rules, 2017 (MDR 2017) whereby device manufacturers or importers must submit ISO 13485 certificates as part of their registrations. Under the draft amendment, Indian market applicants would have until November 30, 2021 to submit “undertakings” declaring their intention to obtain ISO 13485 certification no later than May 31, 2022.

Medical device registration number and labeling considerations

The Indian government’s proposed changes would also allow medical device market applicants to generate provisional registration numbers for device labeling and other purposes; these numbers would remain valid through the May 31, 2022 deadline for full ISO 13485 certification.

Under the current Chapter IIIA requirements, registrants’ ISO 13485 QMS certifications must be complete before they can obtain registration numbers.

Manufacturers opting to submit undertakings but then fail to meet the May 2022 deadline for ISO 13485 certification will have their provisional device registrations cancelled without notice.

The proposed amendments to the Medical Device Rules, 2017 will take full effect upon their final publication in the Gazette of India.

Learn more about medical device registration and compliance in India:


Related resources: 

Related services for India:



  • Stewart Eisenhart