On January 4, 2000, the State Council Order No. 276 announced on February 12, 2014, the revision of the State Council 39th executive meeting, based on the "Regulations on the Amendment of Medical Device Supervision Management" on May 4, 2017 Revised) Chapter 1 General Article 1 In order to ensure the safety and effectiveness of medical devices, this regulation is developed. Article 2 The development, production, operation, use activities and supervision and management of medical devices in the People's Republic of China shall comply with this Regulation. Article 3 The Food and Drug Administration Department of the State Council is responsible for the supervision and management of national medical devices. The relevant departments of the State Council are responsible for the relevant supervision and management of medical devices within their respective responsibilities. The local people's government of the county level is responsible for the supervision and management of medical devices in the administrative region. The relevant departments of local people's governments above county level shall be responsible for the relevant supervision and management of medical devices within their respective responsibilities. The Food and Drug Administration of the State Council shall cooperate with the relevant departments of the State Council to implement national medical equipment industry planning and policies. Article 4 The state has implemented classified management in medical devices in accordance with risk. The first category is low degree, and routine management can guarantee its safe and effective medical instruments. The second category is a moderate risk and requires strict control management to ensure its safety, and effective medical devices. The third category is a high risk, requiring special measures to strictly control management to ensure its safety, and effective medical devices. The degree of risk of medical device should be considered, and the intended purpose, structural characteristics, methods of use of medical devices should be considered. The State Council Food and Drug Administration is responsible for the development of the classification rules and classification catalogs of medical devices, and analyzes, evaluates, evaluates, evaluates, and evaluates, and evaluates, and evaluates the risk changes of medical devices in time, in accordance with medical equipment. Formulate, adjust the classification directory, and you should fully listen to the medical equipment production and operation enterprises and the use of the organization, and the industry organization should be fully understood, and the industry organization should be fully understood and refer to the International Medical Device Classification Practice. The medical device classification directory should be announced to the public. Article 5 The development of medical devices shall follow the principles of safety, effective and saving. The state encourages the research and innovation of medical devices to play the role of market mechanisms, promote the promotion and application of new medical equipment, and promote the development of medical equipment industry. Article 6 The medical device products shall comply with the mandatory national standards for medical devices; there is no mandatory national standard, and should comply with the mandatory industry standards for medical devices. The disposable medical device catalog was developed, adjusted and announced by the State Council Food and Drug Administration. Reuse can be used to ensure safe, effective medical instruments, and do not include a disposable medical instrument catalog. Repeated use of safety and effective medical instruments, which can be adjusted for a one-time medical device catalog, which can ensure safety and effective medical instruments, such as design, production process, and disinfection techniques. Article 7 The medical device industry organization shall strengthen industry self-discipline, promote the construction of integrity system, and urge companies to carry out production and operation activities according to law, and guide enterprises to honesty and trustworthy. Chapter II Medical Device Product Registration and Record Article 8 The first type of medical device implements product record management, second type, and third types of medical equipment implement product registration management. Article 9 Article 9 The first type of medical device product filing and application second type, the third type of medical device product registration shall be submitted: (1) Product risk analysis information; (2) Product technical requirements; (3) Product inspection report; (4) Clinical evaluation information; (5) Product instructions and label samples; (6) Quality management system documents related to product development and production; (7) Other information needed to prove product safety and effectively. The applicant for medical devices shall be responsible for the authenticity of the submitted information. Article 10 The first type of medical device product record shall submit a filing information from the subsidiary of the city-level people's government food and drug supervision and management departments to the site. Among them, the product inspection report can be a self-test report of the filing; clinical evaluation information does not include clinical trial reports, which can be secured by the clinical use of similar products, and data on the safety and effective information of the medical device. Outside the foreign manufacturers of medical devices in my country, the representative agencies established in China or the company's legal persons in my country, as a agent, to the State Council Food and Drug Administration, submit filing information and filing countries ( Regional) The competent department shall allow the certificate of payment of the medical device. If the result of the filing is changed, it shall change the original filing department to change the record. Article 11 Applications for the second type of medical device product registration, the registration applicant shall submit a registration application information to the food and drug supervision and administration department of the people's government in the city, autonomous region, municipality directly under the Central Government. Apply for a third type of medical equipment product registration, the registration applicant shall submit a registration application information to the State Council Food and Drug Administration. In my country, exports to China, foreign manufacturers of medical devices should be used as a representative agency established in my country or a corporate legal personnel in my country, and submit a registration application information to the State Council Food and Drug Administration. And registered applicants (regional) competent authorities in accordance with the authority of the medical device listed sales. The product inspection report in the second category, the third type of medical device product registration application shall be the inspection report issued by the medical device inspection agency; clinical evaluation information should include clinical trial reports, but in accordance with Article 17 of this Regulation The medical device for clinical trials is carried out. Article 12 The food and drug supervision and management department of accepting registration shall be from the date of acceptance.
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