What are the provisions of China's exports of medical devices?

Article 1 to further standardize the food and drug supervision and management departments to issue medical device export sales certificate of service matters for the handling of medical devices, to facilitate the export of medical device manufacturers products, specially formulated this provision. \x0d\ Article 2 in our country has obtained a medical device product registration certificate and production license certificate, or has applied for medical device product filing and production filing, food and drug supervision and management department can for the relevant production enterprise (hereinafter referred to as the enterprise) issued "medical device product export sales certificate" (format see Annex 1). \x0d\ Article 3 The provincial food and drug supervision and management department where the enterprise is located is responsible for the management of the "proof of export sales of medical device products" in the administrative region. \x0d\ Article 4 Enterprises shall submit to the local provincial food and drug supervision and management department or its designated department (hereinafter referred to as the department that issues the certificate) the Registration Form for Certificate of Export Sales of Medical Devices Products (see Annex 2 for the format), and submit the following information stamped with the official seal of the enterprise, which shall be consistent with the actual information on the exported products:\x0d\ (a) a copy of the business license of the enterprise;\ x0d\(ii) copy of medical device production license or filing certificate; \x0d\(iii) copy of medical device product registration certificate or filing certificate; \x0d\(iv) self-assurance statement of the authenticity of the submitted materials and the consistency of the contents in Chinese and English. \x0d\\ Article 5 The department issuing the certificate shall review and check the relevant information submitted by the enterprise. Meet the requirements, should be issued "medical device products export sales certificate"; does not meet the requirements, should promptly explain the reasons. \x0d\ need to issue "medical device products export sales certificate" of the enterprise, its production does not meet the requirements of the relevant laws and regulations, corporate credit rating is low, or in the production of rectification, involved in the handling of the period of time, will not be issued "medical device products export sales certificate". \x0d\ Article 6 of the "Medical Device Products Export Sales Certificate" number is organized as follows: XX Food and Drug Administration Measures out of XXXXXXXXXXXX number. Where: \x0d\ first X represents the abbreviation of the province, autonomous region, municipality directly under the Central Government where the manufacturer is located; \x0d\ second X represents the abbreviation of the municipal administrative region where the manufacturer is located; \x0d\ third to sixth X represents the 4-digit year of issuance of the certificate; \x0d\ seventh to tenth X represents the 4-digit number of proof of the issuance of the water number. \x0d\ Article 7 "Medical Device Products Export Sales Certificate" effective date should not exceed the declaration of information submitted by the enterprise in the various types of documents first arrived at the cut-off date, and the longest not more than 2 years. \x0d\\ Article VIII of the relevant information submitted by the enterprise changes should be promptly reported to the issuing department. Changes in the relevant information or the expiration of the validity period still need to continue to use, the enterprise should re-apply for the "medical device products export sales certificate. \x0d\ Article IX enterprises should establish and maintain export product files. The content includes the processed "medical device product export sales certificate" and "medical device export record form", purchase contracts, quality requirements, inspection reports, certificates of compliance, packaging, labeling styles, customs declarations, etc., in order to ensure that the product export process can be traced. \x0d\ Article 10 Provincial food and drug supervision and management departments shall organize the issuance of certificates within the administrative region of the timely disclosure of information related to the "proof of export sales of medical device products". \x0d\\ Food and drug supervision and management departments found that the production of the relevant enterprises do not meet the requirements of the relevant laws and regulations, the enterprise credit rating dropped to a lower level, or that it is no longer in line with the issuance of proof of the relevant circumstances, as well as changes in the relevant information submitted by the enterprise report, the provincial food and drug supervision and management departments shall promptly notify the relevant information. \x0d\ Article 11 enterprises to provide false proof or take other deceptive means to fraudulently obtain "proof of export sales of medical device products", within five years will no longer be issued for its "proof of export sales of medical device products", and will be the name of the enterprise, the medical device production license or filing certificate number, the medical device product registration certificate or filing certificate number, the legal representative and the organization code and other information to be notified. \x0d\ Article 12 The enterprise shall ensure that the exported products comply with the requirements of the relevant regulations for the export of medical devices, and shall comply with the relevant requirements of the importing country. All legal responsibilities incurred in the export process shall be borne by the enterprise itself. \x0d\ Article XIII of these provisions from September 1, 2015 shall come into force. From the date of implementation of these provisions, any inconsistency between the previous documents and these provisions shall prevail. \x0d\ Article 14 Provincial food and drug supervision and management departments may formulate specific implementation rules in accordance with these provisions. \x0d\\Attachment: 1. Medical device products export sales certificate (format) \x0d\2. Medical device products export sales certificate registration form (format)