What license do I need to apply for to sell COVID-19 antigen detection reagents?
For this, we will explain it to you on behalf of Bangbang enterprises.
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According to the Guangzhou Municipal Market Supervision Bureau, during the epidemic prevention and control period, retail pharmacies that have obtained the Pharmaceutical Trading License and have corresponding storage conditions, or medical device trading enterprises that have obtained the Medical Device Trading License and have corresponding storage conditions can retail COVID-19 antigen detection reagents offline.
Enterprises that meet the business qualification requirements in Guangzhou should register online with the "Three Products, One Machine" platform (website) of Guangzhou Municipal Market Supervision Bureau within 1 day after COVID-19 antigen detection reagents are put into storage or put on shelves.
Without obtaining the domestic medical device registration certificate to sell products, the products involved were seized on the spot, and the pharmacy operators were investigated.
It should also be noted that the applicable population of antigen testing mainly includes the following three categories: those who have symptoms such as respiratory tract and fever to primary medical and health institutions within 5 days; Isolated observers, including home isolated observers, close contacts and sub-close contacts, entry isolated observers, closed control areas and control areas; Community residents who need antigen self-test
From the above, we know that enterprises that want to sell COVID-19 antigen detection reagents need to apply for a Drug Business License or a Medical Device Business License and have corresponding storage conditions.