Zhengzhou Erqi District, medical equipment Class II filing process:
Conditions that need to be met by the Class II medical device filing enterprises:
Enterprises engaged in the operation of medical devices should have the following conditions:
1, the enterprise, the enterprise's legal representative or person in charge of the enterprise, the person in charge of quality management does not have the "Supervision and Administration of Medical Devices Regulations" Article 63, Article 64, Article 65 of the provisions of the situation;
2, with the scale and scope of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;
3, with the scale and scope of operation of the operation of the business premises, the operation of medical devices, storage shall not be set in the Residential homes and other places not suitable for business;
4, with the scale and scope of business appropriate storage conditions, all entrusted to the third-party logistics enterprises of medical devices can not set up storage;
5, with the operation of medical devices appropriate quality management system;
6, with its operation of medical devices products appropriate professional Guidance, technical training and after-sales service capabilities, or agreed to provide technical support by a third party;
7, the specific implementation of standards in accordance with the "Transmission of the State Food and Drug Administration on the issuance of medical device business quality management standard on-site inspection guidelines notice" (Yu Food and Drug Administration [2015] No. 163)
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