The food and drug administration department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative region. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices within their respective areas of responsibility.
The food and drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of national medical device industry planning and policy. Article 4 The state of medical devices in accordance with the degree of risk to implement the classification and management.
The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The food and drug administration department under the state council is responsible for formulating the classification rules and classification directory of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification directory. The formulation and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and refer to the international medical device classification practice. Classification catalog of medical devices shall be published to the public. Article 5 The development of medical devices shall follow the principles of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the popularization and application of new technology of medical devices, and promotes the development of medical device industry. Article VI medical device products shall comply with the mandatory national standards for medical devices; there is no mandatory national standards, shall comply with the mandatory industry standards for medical devices.
Disposable medical device directory by the State Council food and drug supervision and management department in conjunction with the State Council department in charge of health planning to develop, adjust and publish. Repeated use can ensure the safety and effectiveness of medical devices, not included in the single-use medical device catalog. For the design, production process, sterilization technology and other improvements in repeated use can ensure the safety and effectiveness of medical devices, should be adjusted out of the directory of single-use medical devices. Article 7 The medical device industry organizations shall strengthen industry self-discipline, promote the construction of integrity system, supervise enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy. Chapter II Medical Device Product Registration and Filing Article 8 The first class of medical devices to implement product filing management, the second and third class of medical devices to implement product registration management. Article IX Class I medical device product filing and application for Class II, Class III medical device product registration, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection report;
(d) clinical evaluation information;
(e) product instructions and labeling Sample;
(F) and product development, production and quality management system documents;
(VII) to prove that the product is safe, effective and other information required.
Applicants for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted. Article 10 the first class of medical device products for the record, by the filer to the municipal people's government of the location of the food and drug supervision and management department to submit the record information. Among them, the product inspection report can be the filer's self-inspection report; clinical evaluation information does not include clinical trial report, can be through the literature, the data obtained from the clinical use of similar products to prove that the medical device is safe and effective information.
Overseas manufacturers exporting Class I medical devices to China shall submit to the Food and Drug Administration under the State Council the filing information and the documents certifying that the competent authorities of the country (region) where the filer is located have authorized the marketing of the medical device by the representative organization set up in China or by designating an enterprise legal person in China as the agent.
Filing information contained in the matter of change, shall be filed to the original record department to change the record. Article XI application for registration of Class II medical device products, the applicant for registration shall be the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Food and Drug Administration.
To China's exports of Class II, Class III medical devices overseas manufacturers, should be set up by its representative office in China or designated in China as an agent of the enterprise legal person, to the State Council Food and Drug Administration to submit the application for registration information and the registration of the applicant's country (region) the competent authorities to permit the marketing of the medical device documents.
The second class, the third class of medical devices product registration application information in the product inspection report shall be a medical device inspection agency issued the inspection report; clinical evaluation information shall include clinical trial report, but in accordance with the provisions of Article 17 of the Regulations are exempted from clinical trials of medical devices.