Medical device business enterprises shall obtain the following qualifications when selling COVID-19 antigen detection kits as agents:
1, business license
The business scope must include: the third kind of medical device business.
2. Medical device business license
The business scope must include: 2002 classification catalogue: 6840 (diagnostic reagents need to be transported and stored at low temperature); 20 17 classification catalogue 6840 in vitro diagnostic reagents.
Two, drugstore retail COVID-19 antigen test kit, must obtain the following qualifications:
1, business license
The business scope shall include: first, second and third categories of medical device retail (the third category shall be operated according to the items listed in the Medical Device Business License).
2. Medical device business license
The business scope must include: 2002 classification catalogue: 6840 (diagnostic reagents need to be transported and stored at low temperature); 20 17 classification catalogue 6840 in vitro diagnostic reagents.
3. Other relevant retail qualifications, which do not involve the retail of antigen detection kits in COVID-19, can be handled according to the business scope and requirements, such as drug business license, medical device business registration certificate, food business license, etc.
Q: I want to sell the COVID-19 antigen test kit as soon as possible. Is there a quick way?
A: Yes, we have settled in the third-party medical device park and started a medical device business enterprise.
Q: What qualifications do I need to apply for to start a medical device business enterprise?
A: Business license and medical device business license.
Q: How much does it generally cost to set up a medical device business enterprise on a third-party platform?
A: Prices vary. For example, in economically developed areas, the settlement cost is relatively high, including the cold chain price ranging from 40,000 to 50,000 yuan/year; Other areas, including the cold chain, have prices ranging from 30,000 to 40,000 yuan/year.
Q: Is there any way to reduce the settlement fee?
A: Yes. Settle in the policy park and enjoy preferential tax policies. Suppose you make an annual profit of 5 million yuan, enjoy 30% value-added tax and 15% enterprise income tax, and you can get 306,000 yuan of financial support funds. The settlement fee of 40,000-50,000 yuan per year is not considered as expenditure.
Q: How soon can I apply for the relevant business qualifications for starting a medical device business enterprise?
Answer: To ensure the uniqueness of enterprise brand name, the shortest time is 19 days.