Does the production of an in vitro diagnostic reagent need a factory?

Need. Announcement of China Food and Drug Administration (No.103,2015) on Issuing the Appendix of in vitro Diagnostic Reagents to the Quality Management Specification for Medical Device Production. Workshops and facilities should have a clean production environment. The ground, road surface and surrounding environment of transportation in the factory area should not cause pollution to the production of products. The overall layout of administrative area, living area and auxiliary area is reasonable, and it shall not adversely affect the production area. Factories should stay away from areas with air and water pollution. The production workshop should be equipped with dust-proof facilities to prevent insects and other animals from entering. The doors, windows and safety doors of clean room (area) should be sealed, and the doors of clean room (area) should be opened in the direction of high cleanliness.