Outside the processing of nucleic acid test kits in the factory need to be approved by which departments of the audit

Municipal people's government food and drug supervision and management department, the State Drug Administration. External processing of nucleic acid test kit production of various raw materials, auxiliary materials and so on should be formulated its corresponding quality standards, and should meet the requirements of relevant regulations. Outside the processing of nucleic acid test kit production enterprises should have the appropriate professional and technical personnel, equipment and suitable production environment to obtain a "medical device production license.