What qualifications are needed to produce medical devices

Industrial and commercial business license, medical device production license, medical device registration certificate, ISO quality management system certification, product quality inspection report.

According to the query of Anning Medical Devices, the medical device production license and medical device registration certificate is the core qualification of medical device production, approved by the State Food and Drug Administration. Professional medical device manufacturers and production equipment, standardized production workshop, strict production process and quality control system, professional R & D team and after-sales service team, etc. are required.