Antigen reagent business needs what qualification

According to the "State Drug Administration Comprehensive Division on the new coronavirus antigen test reagents to do a good job of quality and safety supervision of the work of the notice" requirements, during the epidemic, meet the following requirements can be engaged in the operation of the new coronavirus antigen test reagents:

To obtain the "drug license" of the drugstore;

To obtain the "medical device license" of the medical device business enterprises, engaged in the new coronavirus antigen test reagents Wholesale of new coronavirus antigen test reagents, the scope of business needs to include three types of in vitro diagnostic reagents;

engaged in the network sales of new coronavirus antigen test reagents need to obtain a "Medical Device License" and "Shandong Province, the medical equipment network sales of information for the record", and the scope of business needs to include three types of in vitro diagnostic reagents.

Pharmacy sales of medical devices need to have the following qualifications:

1. Engaged in

the first class medical devices do not need to apply for licensing and filing.

2. Engaged in

second class

medical device business, need to apply for the "second class of medical equipment business record certificate";

3. Engaged in

third class

medical device business, need to apply for the "medical device business license".

Business enterprises in Shandong Province Food and Drug Administration administrative licensing service platform to submit the relevant information. (Tel: 88036026).

"Medical Device License" on-site verification link, Laoshan District Market Supervision Bureau will be based on "Medical Device Business Quality Management Code on-site inspection guiding principles" requirements for on-site verification. (Tel: 68066760)

Medical equipment business to note:

1. Engaged in medical equipment business activities, should have with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of the medical equipment and quality management system and quality management institutions or personnel.

2. Purchase of medical devices:

(1) should check the supplier's qualifications and medical equipment qualification documents, including business license (whether or not the qualification of medical equipment business), medical device record certificate or medical device registration, medical device license, medical device manufacturing license.

(2) To determine the legitimacy of the purchased medical devices, the two sides need to sign a purchase contract and quality assurance agreement to ensure the quality of the product.

(3) Purchase of medical devices need to be accompanied by a single and product inspection report, and the establishment of purchase inspection record system.

(4) can be through the State Drug Administration website (on the product information to query.

(5) Purchase of medical devices, need to check the product specification, labeling and registration or filing of the relevant content is consistent to ensure that the true and accurate.

3. "Class II medical device record certificate", "medical device license" should be hung in a conspicuous position.

4. Medical devices and non-medical devices should be stored separately, not mixed.

5. Temperature and humidity detection equipment and other measuring instruments for regular calibration or verification, calibration or verification records, and make a good temperature and humidity testing records.

6. Engaged in the second, third-class medical device wholesale business and third-class medical device retail business enterprises, should also establish sales records, third-class medical device sales enterprises should establish a computer system to ensure that the information is traceable.