I. Conditions for Filing An enterprise engaged in the business of medical devices shall meet the following conditions:
1. The enterprise and its legal representative or the person in charge of the enterprise and the person in charge of quality management do not have the circumstances stipulated in Articles 63, 64 and 65 of the Regulations on the Supervision and Administration of Medical Devices;
2. There are quality management institutions or quality management personnel suitable for the scale and scope of operation, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state;
3. It has a business place suitable for the scale and scope of operation, and the business and storage place of medical devices shall not be located in residential buildings or other places unsuitable for operation;
4. It has the storage conditions suitable for the scale and scope of operation, and all medical devices entrusted to third-party logistics enterprises can be left without warehouses;
5. Having a quality management system suitable for operating medical devices;
6. Having the professional guidance, technical training and after-sales service capabilities suitable for the medical device products it deals in, or agreeing to provide technical support by a third party;
7. Enterprises engaged in the operation of third-class medical devices shall establish a computer information management system suitable for the operation scale.
8. The specific implementation standards shall be implemented in accordance with the "On-site Inspection and Acceptance Standards for Medical Device Enterprises in Henan Province" (Yu No.24).
Second, the filing procedure
1, filing materials submitted by enterprises
2. Review the materials. Check the integrity of the filing materials, and put them on record if they meet the prescribed conditions. If the filing materials are incomplete or do not conform to the prescribed form, it shall inform all the materials that need to be supplemented at one time. If it is not filed, it shall inform the applicant on the spot and explain the reasons.
3, director of the review
4. Signature of the competent director.
5. Issue a filing certificate
6. Online publicity
Three. Submission of materials
1. Operation Record Form of Class II Medical Devices;
2 copies of business license and medical device business license (if any);
3 copies of the identity, education and professional title certificates of the legal representative or person in charge of the enterprise and the person in charge of quality;
4. Description of the organization and department of the enterprise;
5. A copy of the geographical location map, floor plan (indicating the actual use area), house property certificate and lease agreement (with house property certificate attached) of the business address and warehouse address of the enterprise;
6. Catalogue of business facilities and equipment;
7 enterprise management quality management system, working procedures and other documents;
8. The authorization certificate of the agent;
9. Other supporting materials. The filing materials shall be complete and clear, printed and bound with A4 paper and attached with the table of contents, and the copies shall be submitted together with the electronic version after being stamped with the official seal.
Fourth, the change of filing certificate.
If the enterprise name, legal representative, person in charge of the enterprise, person in charge of quality, business scope, business address and warehouse address in the Record Certificate of Medical Device Business are changed, it shall be re-filed and returned to the original Record Certificate of Medical Device Business.
Verb (abbreviation of verb) Re-issuance of filing vouchers
If a medical device business enterprise loses the Record Certificate of Medical Device Business, it shall immediately report to the municipal food and drug supervision and administration department with districts, and issue a loss statement in the designated media. After 1 month after the release of the loss reporting statement, the medical device business registration certificate shall be reissued within 10 working days after receiving the application from the medical device business enterprise.