Antigen kit sales qualification

First, the medical device business enterprise agent sales of new coronavirus antigen test kit, must obtain the following qualifications: 1, "Business License"

business scope must include: Class III medical device business.

2, "Medical Device License"

business scope must include: 2002 classification: 6840 (diagnostic reagents require low-temperature refrigerated transport and storage); 2017 classification 6840 in vitro diagnostic reagents.

Second, the pharmacy retail new coronavirus antigen test kits, must obtain the following qualifications:

1, "Business License"

business scope must include: one, two, three types of medical devices retail (three types of medical devices according to the "Medical Device License" listed in the project business).

2, "Medical Device License"

business scope must include: 2002 classification: 6840 (diagnostic reagents require low-temperature refrigerated transport storage); 2017 classification 6840 in vitro diagnostic reagents.

3, other related retail qualifications, because it is not involved in the retail of new coronavirus antigen test kit, according to the scope of business and requirements can be handled, such as the "Drug License", "Medical Device Business Record Certificate", "Food Business License" and so on.

Q:I want to sell the new coronavirus antigen test kit as fast as possible, is there a fast way?

A:Yes, you can set up a medical device business in a third-party medical device park.

Q:Where do I need to qualify to start a medical device business?

A:Business license, medical device license.

Q:How much does it cost to start a medical device business on a third-party platform?

A: The price varies, such as economically developed regions, the stationing fee is relatively high, including the cold chain price of 40,000-50,000 yuan/year; other regions including the cold chain price of 30,000-40,000 yuan/year.

Q: Is there a way to reduce the cost of entry?

A:Yes. Settle in the policy park, enjoy tax incentives. Assuming your annual profit is 5 million, you can get 306,000 RMB as financial incentives for 30% VAT and 15% EIT, which is not an expense of 40,000-50,000 RMB a year.

Q: start medical equipment business enterprises, the fastest how long can handle the relevant business qualifications?

A: To ensure the uniqueness of the enterprise name, the quality of the person in charge of the post in the job, the fastest 19 days.