 "Medical Device (Amendment) Rules")
The Union government has notified the Medical Devices Rules on Tuesday as Medical Devices (Amendment) Rules, 2022. The Rules made provisions for all class A medical device manufacturers to register themselves through an identified online portal established for the purpose.
Class A medical devices are those with low-to-moderate risk to the patient or user (like surgical dressings). All class A and class B manufacturers are required to transition to the licensing regime by October 1.
Several manufacturers are awaiting audits from the government licensing authorities. Online registration with self declaration would make this transition process easier.
The manufacturer has to
