1. What types of medical devices do antigen detection reagents belong to?
Because the new G virus involves infectious diseases, the new G antigen self-test detection reagents belong to the 6840 in vitro diagnostic reagents under the third category of medical devices;
Operating enterprises need to obtain the third category of medical devices Only those who have a business license and the business scope of 6840 in vitro diagnostic reagents can operate and sell.
Note: (1) 6840 in vitro diagnostic reagent:
1. Person in charge of the company: college degree or above;
2. Quality management personnel: 1 person in charge Inspectors, or those with a university degree or above in inspection-related majors and more than 3 years of work experience in inspection-related work. Quality management personnel should be on-the-job and not part-time;
3. After-sales and acceptance: should have a technical secondary school degree or above in inspection or a professional technical title of junior inspector or above;
4. Enterprise custodial, sales and other personnel: should have a high school or technical secondary school education or above.
5. Office business premises: should be commensurate with the business scale and shall not be less than 100 square meters;
6. Warehouse (excluding cold storage): the area shall not be less than 60 square meters , cannot be residential;
7. The cold storage must not be less than 20 cubic meters.
2. Processing conditions:
According to Article 7 of the "Measures for the Supervision and Administration of Medical Device Business", those engaged in the business of medical devices must meet the following conditions:
( 1) Have a quality management organization or quality management personnel that is consistent with the business scope and scale of the business, and the quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state;
(2) Have a quality management organization or quality management personnel that is consistent with the business scope and scale Business and storage locations commensurate with the scale;
(3) Having storage conditions commensurate with the business scope and business scale, if all storage is entrusted to other medical device business enterprises, there is no need to set up a warehouse;
(4) Have a quality management system that is suitable for the medical devices it operates;
(5) Have the ability to provide professional guidance, technical training and after-sales service that are suitable for the medical devices it operates, or It is agreed that relevant institutions will provide technical support. Enterprises engaged in the operation of Class III medical devices should also have a computer information management system that meets the quality management requirements for medical device operations to ensure that the products they operate can be traced.
3. Required materials:
General situation: Notes
1. "Medical Device Business License Application Form"
2. "Business License"
3. Documents proving the business site and warehouse location, including real estate certificate or lease agreement
4. Geographical location map and layout of the business site and warehouse address Floor plan
5. Copies of the identity certificates of the legal representative, the person in charge of the enterprise, and the person in charge of quality (manager), copies of the academic qualifications or professional title certificates of the person in charge of quality (manager), and relevant work experience Copies of supporting documents and personal resume
6. "List of Technical Personnel" and 1 copy each of ID card, academic qualifications, and professional title certificates
7. Catalog of operating and warehousing facilities and equipment