Individuals who want to sell antigen first need to apply for a "business license", followed by "medical equipment business license", individuals should also have a "health certificate".
Legal basis: "Chinese People's **** and the National Product Quality Law" Article 35 sellers shall not sell the state ordered to phase out and stop selling products and invalid, deteriorating products. Article 39 sellers selling products, shall not be adulterated, adulterated, shall not be false for real, substandard, shall not be unqualified products as qualified products.
If you want to sell test reagents, you need to meet the following requirements:
1, you need to have a medical device license, proving that the company has the qualification to operate medical devices.
2, need to have a test reagent production license, proving that the company has the technical ability to produce test reagents.
3, need to have a test reagent business record certificate, proving that the company has been filed with the business registration authority, and in line with relevant laws and regulations.
4, need to have test reagent test report, proving that the company's production of test reagents in line with quality standards.
5, need to have a test reagent quality management system certification, to prove that the company has a sound quality management system to ensure that the quality of test reagents can be controlled. Medical devices are divided into three categories: Class I medical devices, Class II medical devices and Class III medical devices.