Business records of Class II medical devices.
(1) Since June, 20 14, those who engage in the business of Class II medical devices shall fill out the Record Form for the Business of Class II Medical Devices (see Annex 4), file with the local municipal food and drug supervision and administration department, and submit the record materials that meet the requirements of the record materials for the business of Class II medical devices (see Annex 5).
The municipal food and drug supervision and administration department of a district that receives the filing materials for the operation of medical devices shall verify the integrity of the filing materials on the spot, and put them on record if they meet the prescribed conditions, and issue the Certificate for the Record of Operation of Medical Devices of Category II (see Annex 6).
The numbering rule of the record number of the second type of medical device business record certificate is: XX equipment of the US Food and Drug Administration XXXXXXXX. Among them, the first X represents the Chinese abbreviation of the province, autonomous region and municipality directly under the Central Government where the filing department is located, the second X represents the Chinese abbreviation of the municipal administrative region with districts, the third to sixth X represents four filing years, and the seventh to tenth X represents four filing serial numbers.
(2) If the business license for Class II medical devices has been obtained before June, 2065438+04 1, there is no need to re-apply for filing. If the business license expires and it is necessary to continue to engage in business, it shall be filed.
20 1 April1The food and drug supervision and administration department that has accepted the application for the business license of Class II medical devices shall notify the enterprise to handle the filing in accordance with the new regulations.
(3) Implement the Notice on Publishing the First Batch of Class II Medical Device Products without Medical Device Business License (SFDA [2005] No.239) and the Notice on Publishing the Second Batch of Class II Medical Device Products without Medical Device Business License (SFDA [20 1 1).
Requirements for application materials for the operation of Class II medical devices
1. Operation Record Form of Class II Medical Devices;
2. A copy of the business license of the enterprise;
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 title certificate or lease agreement (with house title 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.