2. Field record
If the data is qualified in the preliminary examination, the record certificate shall be filed on the spot.
3. Information publication
The Department of Medical Devices will send the filed electronic files to the Department of Regulations for publication on the website, and regularly submit the filing information to the provincial food and drug administration.
Requirements for filing of Class II medical devices:
(1) Having a quality management organization or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) Having a relatively independent business place suitable for its business scale and business scope;
(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
(four) establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system;
(5) It shall have the technical training and after-sales service capabilities suitable for the medical device products it deals in, or agree to provide technical support by a third party.
Extended data:
Records of Class II medical devices:
1. Copy of business license (original inspection);
2, the legal representative of the enterprise, the person in charge, the person in charge of quality management ID card, diploma or title certificate copy and resume;
3. A copy of the ID card, education or professional title certificate of the enterprise quality management personnel to be employed;
4. The organization and functions of the proposed enterprise or the functions of full-time quality management personnel;
5. A copy of the geographical location map, floor plan (indicating the usable area), house property right certificate or lease agreement (attached with the leased house property right certificate, the same below) of the business premises and warehouse address of the proposed enterprise;
6. Product quality management system documents, working procedures (in vitro diagnostic reagent wholesale enterprises only) and storage facilities and equipment catalogue of the enterprise to be operated;
7. The authorization certificate of the agent;
8. Other supporting materials.
References:
Xining Municipal People's Government-Management of Class II Medical Devices for the Record
References:
Baidu Encyclopedia-Business Records of Medical Devices of Class II