GMP certification plays a crucial role in the medical device approval process by ensuring that manufacturers adhere to stringent quality and safety standards. It demonstrates that a facility consistently produces devices meeting regulatory requirements. W

The MFDS conducts GMP inspections for medical devices by evaluating manufacturing facilities for compliance with established quality standards. Inspectors review documentation, assess production processes, and verify the implementation of quality control measures. They may also conduct interviews with staff and inspect equipment, ensuring adherence to regulations and identifying any areas needing improvement or corrective action.