1, having business premises and storage conditions suitable for the business scale and scope, as well as quality management systems and quality management institutions or personnel suitable for the medical devices operated.
1. The operation of medical devices shall be filed with the municipal food and drug supervision department of the local district. Engaged in the third kind of medical device business, the business enterprise shall apply to the food and drug supervision and administration department of the municipal people's government with districts where it is located for a business license, which shall be examined and approved by the food and drug supervision and administration department of the municipal people's government with districts where it is located, and a Medical Device Business License shall be issued.