What qualifications are needed to produce new coronavirus detection reagents

The production of new coronavirus detection reagents belongs to three categories of medical devices, and its production qualifications are reviewed and managed by the National Medical Products Administration (NMPA)

Therefore, the production of such masks requires strict production qualifications, the qualifications are as follows (the following pictures are from the official website of the State Drug Administration):

  • Medical Device Product Registration Certificate Medical Device Registration

This company Shanghai Fuxing Long March Medical Science Co., Ltd.
The registered medical product is New Coronavirus (2019-nCoV) nucleic acid detection kit (fluorescence PCR method)
Level Three categories
Certificate No. National Machinery Note 20203400299, you can see the approval date is the most recent epidemic period

  • Medical Device Manufacturing License

  • Recording of medical device production

  • Medical Device Business License

  • Medical device operation record

Not all of the above qualifications are required
If it is a medical device, it must have a medical device production license or production record
If it is selling medical devices, it must have a medical device business license or record

See list of manufacturers of new domestic coronavirus detection reagents
See Description of new coronavirus detection reagents belonging to several types of medical devices

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