Administrative Measures for Medical Device Registration (Order No.4 of CFDA) July 30, 2014 Order of China Food and Drug Administration No.4 Administrative Measures for Medical Device Registration, passed by China Food and Drug Administration at the administration affairs meeting on June 27, 2014, are hereby promulgated and shall go into effect as of October 1, 2014. Minister of CFDA Zhang Yong July 30, 2014 Administrative Measures for Medical Device Registration Chapter I General Provisions Article 1 In order to standardize the registration and filing administration of medical device and guarantee the safety and effectiveness of medical device, the Administrative Measures are formulated in accordance with Regulations for the Supervision and Administration of Medical Device. Article 2 All medical devices sold and used within the territory of the Peoples Republic of China shall apply for registration or conduct filing in accordance with the Administrative Measures. Article 3 Medical device registration refers to approval process conducted by the food and drug administration upon an application submitted by the registration applicant, following the legal procedure to decide whether the medical device to be marketed can be approved or not based on a comprehensive assessment on research and results of medical devices safety and effectiveness. Medical device filing refers to the food and drug administration files filing materials submitted by the filing applicant for future reference. Article 4 Registration and filing of medical device shall follow the principles of publicity, justice, and equity. Article 5 Filing administration shall be implemented for Class I medical device. Registration administration shall be implemented for Class II and Class III medical device. For filing of domestic Class I medical device, the filing applicant shall submit the filing to the local municipal food and drug administration. Domestic Class II medical device shall be inspected by the food and drug administrations of provinces, autonomous regions, municipalities directly under the central government, and the registration certificate for medical device will be issued after approval. Domestic Class III medical device shall be inspected by the China Food and Drug Administration (hereinafter referred to as CFDA), and the registration certificate for medical device will be issued after approval. For filing of imported Class I medical device, the filing applicant shall submit the filing to CFDA. Imported Class II and Class III medical device shall be inspected by the CFDA, and the registration certificate for medical device will be issued after approval. Beijing Codex translation Co.,Ltd. www.codex-trans.com infocodex-trans.com For reference only. For legal basis, the original version in Chinese shall prevail. The medical device from Hong Kong, Macau and Taiwan shall be registered or filed as imported medical device. Article 6 The registration applicant and filing applicant shall launch product to the market in its own name and hold legal liability for the product. Article 7 The food and drug administration shall publicize information of medical device registration and filing in accordance with laws regulations. The applicant can inquiry the approval process and results, the public can look up approval results. Article 8 China encourages research and innovation of medical device, conducts special approval procedures for innovative medical device, contributes to promotion and application of new technology of medical device and boosts the development of medical device industry. Chapter II Basic Requirement Article 9 The registration applicant or the filing applicant shall establish quality management system related to R when domestic products not approved by the special approval procedures for innovative medical device apply for registration application, another manufacturer cannot be entrusted to produce samples. Article 10 The person that apply for registration or conduct filing for medical device shall have the corresponding professional knowledge and be familiar with laws, regulations, normative documents and technical requirements regarding medical device registration or filing administration. Article 11 The applicant or the filing applicant shall follow the basic requirements for safety and effectiveness of medical device, ensure that R (2) Deliver related laws, regulations and technical requirements to the applicant or the filing applicant Beijing Codex translation Co.,Ltd. www.codex-trans.com infocodex-trans.com For reference only. For legal basis, the original version in Chinese shall prevail. truly and faithfully; (3) Collect post-market adverse event information of medical device and feed them back to the overseas applicant or the filing applicant, meanwhile, report them to relevant food and drug administration; (4) Coordinate the recall for post-market medical device, and report to relevant food and drug administr