What certificate do I need to sell the kit?

What certificate do I need to apply for to sell COVID-19 test kit? Due to the spread of COVID-19, the demand for COVID-19 test kits at home and abroad has greatly increased. Does COVID-19 nucleic acid detection kit belong to medical devices? What qualifications do I need to apply for to sell COVID-19 test kits? COVID-19 test kit belongs to the category 6840 of in vitro diagnostic reagents. Operating three types of medical equipment is different from operating the first and second types of medical equipment. Only a business license is required to operate a class I medical device, a class II medical device needs to be filed with the Food and Drug Administration, and a class III medical device needs a medical device business license. 、

What certificate do I need to apply for to sell COVID-19 test kit?

It should be noted that to apply for a business license for three types of medical devices, the business scope column in the general business license needs to clearly state that three types of medical devices can be sold. If not, you need to go to the industrial and commercial bureau to add items. In addition, the sale of such products must have its own warehouse, and it is necessary to set up a cold storage in the warehouse, because the three types of medical devices need to be insulated, and they will easily deteriorate if they exceed a certain temperature, which will affect the product quality.

Conditions for business license of medical devices of category III:

1. The business scope of the business license includes medical device business (sales).

2. There are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have professional qualifications or titles recognized by the state;

3. Having business and storage places suitable for the business scope and scale;

4. It has the storage conditions suitable for the business scope and scale, and all the storage entrusted to the third-party medical device business enterprise can be stored without a warehouse;

5. Having a quality management system suitable for operating medical devices;

6. Having professional guidance, technical training and after-sales service capabilities suitable for the medical devices operated, or agreeing to provide technical support by a third-party organization.

Three types of medical device business license information:

1. Application Form for Medical Device Business License;

2. Qualification certificate;

3. Copy of business license or pre-approval certificate of enterprise name;

4. Qualification certificate of quality manager;

5. Qualification certificate of after-sales service personnel.

Three types of medical device business license process:

1. Managers of operating enterprises shall bring the above information to the food and drug supervision and administration department of the local municipal people's government with districts to apply for a business license;

2, the staff to accept the information, and within 30 working days to review, organize verification when necessary;

3, to meet the prescribed conditions, grant permission and issue a medical device business license; If it does not meet the prescribed conditions, it shall not be permitted and the reasons shall be explained in writing.