Name of service item: Business records of Class II medical devices.
Setting basis: Article 30 of the Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.650th) and Article 12 of the Measures for the Supervision and Administration of Medical Devices.
Application conditions: To engage in business activities of medical devices, there should be business premises and storage conditions suitable for the scale and scope of business, as well as a quality management system and quality management institutions or personnel suitable for the medical devices operated.
Handling materials:
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. Catalogue of application 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.
Venue: the window of Hefei US Food and Drug Administration on the second floor of Hefei Municipal Affairs Service Center.
Processing time: 1 working day
Charging standard: no charge.
Handling process: Hefei US Food and Drug Administration accepts the application at the window → material review → making an administrative licensing decision → making a certificate → issuing a certificate.
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