A. Antigen detection reagents belong to several classes of medical devices?
Because the new G virus involves infectious diseases, the new G antigen self-test test reagent belongs to the third class of medical devices under the 6840 in vitro diagnostic reagents;
Business enterprises need to obtain the third class of medical device license and 6840 in vitro diagnostic reagents business scope in order to operate sales.
Note: (a) 6840 in vitro diagnostic reagents:
1, the person in charge of the enterprise: college degree or above;
2, quality management personnel: a person in charge of the examiner, or a university degree in a laboratory-related field and engaged in testing-related work for more than 3 years of work experience. Quality management personnel should be on duty, not part-time;
3, after-sales, acceptance: should have a secondary school education or above in inspection or with the inspector above the junior professional and technical title;
4, corporate custodianship, sales and other personnel: should have a high school or secondary school education.
5, office space: should be compatible with the scale of operation, not less than 100 square meters;
6, warehouse (excluding cold storage): the area of not less than 60 square meters, can not be residential;
7, cold storage shall not be less than 20 cubic meters.
Two, the conditions:
According to the "supervision and management of medical devices" Article 7, engaged in the operation of medical devices, shall have the following conditions:
(a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a national Recognition of the relevant professional qualifications or titles;
(B) with the scope of business and business scale appropriate business, storage space;
(C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
(D) with the operation of medical equipment quality management system;
(D) with the operation of medical equipment appropriate Management system;
(E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support. Enterprises engaged in the operation of Class III medical devices should also have a computer information management system that meets the requirements of quality management of medical device business, to ensure that the operation of the product can be traced.
Three, the required materials:
General: Notes
1 . Medical Device License Application Form
2 . Business License
3 . Business premises, warehouse premises supporting documents, including property certificates or lease agreements
4 . Business premises, warehouse address location map, layout plan
5 . Legal representative, the person in charge of the enterprise, the quality of the person in charge (manager) of a copy of the identity card, the quality of the person in charge (manager) of a copy of the certificate of education or title, a copy of the relevant work experience and a copy of the documents and personal resume
6 . List of Technical Personnel and a copy of ID card, education, title certificates
7. Catalog of operating and storage facilities and equipment