Medical device product manufacturing standards for precision processing of medical parts

u200b　　 Everyone knows that medical device products are different from other automation or other industry equipment and equipment. The country has strict standards to control this. Shenzhen Hongweisheng Precision Technology, which is committed to the precision processing of medical parts, will share with you the medical device product manufacturing standards. What are there, let's find out together.　　 1. Examination and Approval Authority: Enterprises operating Class II and Class III medical devices shall report to the Provincial Drug Administration for review and approval, and issue the 'Medical Device Operating Enterprise License'. 1. Provincial enterprises (registered with the Provincial Administration for Industry and Commerce) are directly accepted by the Provincial Drug Administration; 2. Other enterprises and units are accepted by the drug regulatory authorities of each city and undergo preliminary examination and acceptance. If they are qualified, write a written acceptance opinion and sign in the review form After the preliminary review, the opinions are submitted to the Provincial Product Supervision Bureau for approval. 2. Application materials: 　　1, 1 application report; 　　2, fill in the 'Medical Device Operating Enterprise License' application form in 3 copies (the copy is invalid); 　　3, the enterprise (company) articles of association and the latest capital verification report (provided for renewal) Enterprise balance sheet and profit and loss statement) 1 copy; 　　4, enterprise self-examination summary (contrasted with 'Guangdong Province Medical Device Operating Enterprise Qualification Approval Implementation Rules' and 'Guangdong Province Verification, Replacement and Acceptance Standards' requirements) 1 copy; 　　5, A list of technical and maintenance personnel and one copy of their graduation certificate and professional title certificate (with the official seal of the unit); 　　6. One copy of the property right certificate or lease agreement and floor plan of the business and storage site; 　　7. Detailed written preliminary review by the Municipal Drug Administration 1 copy of acceptance report (except for provincial enterprises); 　　8. One copy of the enterprise name business pre-registration certificate or a copy of the 'Corporate Business License'; 　　9, various management rules and regulations. a. Quality responsibility and veto system; b. Inbound acceptance, storage and outbound review system; c. Quality analysis and feedback system; d. Validity management system; e. Retail sales quality management system; f. Special and imported medical care Device management system; g. After-sales service (installation, use technical training, maintenance, repair, etc.) system; h. Implantation and special medical device quality tracking and adverse reaction reporting system; i. Return, unqualified, expiration date or obsolete medical treatment Device handling report system; j. Hygiene management system; 　　 10. Self-assurance statement on the authenticity of the provided information.