What license do you need to sell kits

What kind of license is needed to sell the new crown test kit? Because of the spread of the new crown, domestic and foreign for the new crown virus test kit demand has increased significantly. Is it a medical device? What kind of license do I need to sell the test kits? The new crown test kit belongs to the third class of medical devices in vitro diagnostic reagents category 6840, the operation of the third class of medical devices is different from a class of medical devices and second class, the operation of a class of medical devices only need to have a business license can be, the operation of the second class of medical devices need to be filed to the Pharmacy and Drug Administration, and the operation of the third class of medical devices need to apply for the "Medical Device License".

What kind of license is needed to sell the new crown test kits?

It should be noted that, for the three types of medical equipment business license, the general business license on the business scope of this column, need to be clearly written to sell three types of medical equipment, if not, you need to go to the Trade and Industry Bureau for the addendum. In addition, the sale of such products must be their own warehouse, and the warehouse needs to be set up in the cold storage, because the three types of medical equipment, is the need for insulation, more than a certain temperature, it is easy to deteriorate and affect product quality.

Three types of medical equipment business license conditions:

1, business license business scope includes medical equipment business (sales)

2, with the scope of business and business scale of the quality management institutions or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;

3, with the scope of business and scale of operation of the business, storage space;

4, with the scope of business and scale of operation of the storage conditions, all entrusted to third-party medical equipment business enterprises can not set up storage;

5, with the operation of medical equipment quality management system;

6, with the operation of medical equipment with appropriate professional Guidance, technical training and after-sales service capabilities, or agreed to provide technical support by third-party organizations.

Three types of medical equipment business license information:

1, "Medical Device Business License Application Form";

2, proof of qualification;

3, a copy of the business license or pre-approval of the business name documents;

4, the quality of proof of qualification of managers;

5, after-sales service personnel. Proof of qualification.

Three types of medical equipment license process:

1, the business enterprise operator with the above information to the municipal people's government of the location of food and drug supervision and management department to apply for a license;

2, the staff accepts the information and within 30 working days for review, if necessary, the organization of verification;

3, to meet the required conditions, and issued to the medical device license; do not meet the required conditions, not licensed and a written explanation of the reasons.