Which departments need to approve and audit the factory that processes nucleic acid detection kits outside?
The food and drug supervision and administration department of the Municipal People's Government and the national drug supervision and administration department. Various raw and auxiliary materials used in the production of external processing nucleic acid detection kits should formulate their corresponding quality standards and meet the requirements of relevant laws and regulations. The production enterprise of externally processed nucleic acid detection kit shall have corresponding professional and technical personnel, instruments and equipment and a suitable production environment, and obtain a production license for medical devices.