Nucleic acid swab factory need qualification

Nucleic acid swab factory needs qualification. Swabs belong to medical devices, manufacturers have class II medical device production qualification, and through the ISO13485 or ISO9001 quality certification. Also need a health license. China's medical device management methods have clear provisions, the production of medical devices need to apply for a health license, sales, use of medical devices must be claimed (which includes health license), the lack of health license products are not allowed to enter the circulation chain.