Medical Device Manufacture Permit Licence

Legal basis

• 1
  Measures for supervision and administration of medical device production
• 2
  NMPA circular on issuing catalogue forbidding commissioned production of medical devices
• 3
  Guidelines for The Preparation of Quality Agreement for Commissioned Production of Medical Devices (Draft)

Flow chart of the license of medical device production enterprise

Documentation flow chart of medical device production enterprises

The required documents:

Refer to the local food and drug administration rules