A. Antigen detection reagents belong to how many classes of medical devices?
Because the new G virus involves infectious diseases, the new G antigen self-testing test reagent belongs to the 6840 in vitro diagnostic reagents under the three classes of medical devices;
Operating companies need to obtain the three classes of medical devices business license and 6840 in vitro diagnostic reagents business scope before operating 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 with a university degree in testing related disciplines 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 the 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 computerized 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