Article 1 These Provisions are formulated for the purpose of further standardizing the handling of service matters for which the food and drug regulatory departments issue certificates of export sales of medical devices, and facilitating the export of products of medical device manufacturers.
Article 2 Where the medical device product registration certificate and production license certificate have been obtained in China, or the medical device product record and production record have been handled, the food and drug regulatory department may issue the Certificate of Export Sales of Medical Device Products (hereinafter referred to as the enterprise) for the relevant manufacturing enterprises (hereinafter referred to as the enterprise) (see Appendix 1 for the format).
Article 3 The provincial food and drug regulatory department where the enterprise is located shall be responsible for the administration of the Certificate of Export Sales of Medical Devices products within its administrative region.
Article 4 an enterprise shall to the local provincial food and drug supervision and administration department or the designated department (hereinafter referred to as the department) to certify that submit export sales prove that the medical devices registration form "(see format in annex 2), and submit the following information is stamped with enterprise stamp, information content should be consistent with the actual information export products:
(1) A copy of the business license of the enterprise;
(2) a copy of the production license or the record certificate for medical devices;
(3) a copy of the registration certificate or record-keeping certificate of the medical device;
(4) A self-assurance statement of the authenticity of the submitted materials and the consistency of the contents in both Chinese and English.
Article 5 The certifying authority shall examine and verify the relevant materials submitted by the enterprise. If it meets the requirements, the Certificate of Export Sales of Medical Devices shall be issued; If it does not meet the requirements, it shall give reasons without delay.
If an enterprise that needs to issue the Certificate of Export Sales of Medical Devices does not meet the requirements of relevant laws and regulations, has a low credit rating, or is in the process of production rectification or case handling, it shall not issue the Certificate of Export Sales of Medical Devices.