QMS requirements clarified for Class A NSNM medical devices

Indian central Health ministry has amended the Medical Devices Rules, 2017 to expressly require manufacturers and importers of Class A non-sterile and non-measuring medical devices to self-certify compliance with applicable standards and Quality Management System (QMS) requirement. The amendment strengthens quality controls for these devices under the registration framework.

Join our 1500+ subscribers to get our daily Health Laws and Policy Updates.