The guiding principles include seven parts, respectively, for the preparation of the purpose, regulatory basis, scope of application, basic principles, included in the "exempted from clinical trials of the second class of medical devices directory", "exempted from clinical trials of the third class of medical devices directory" (hereinafter referred to as the "directory") of the product's clinical evaluation requirements, the analysis of data obtained through the same varieties of medical devices clinical trials or clinical use of data Evaluation requirements, clinical trial-related requirements. According to the requirements of the Guidelines, for the products listed in the Catalogue, the applicant for registration shall submit comparative information between the relevant information of the declared products and the contents described in the Catalogue and comparative descriptions between the declared products and the medical devices in the Catalogue which have been approved for domestic registration; if the corresponding comparative descriptions can prove that the products are the products in the Catalogue, then the enterprises do not need to carry out the clinical trials. If it cannot be proved that the declared product is equivalent to the product in the Catalog, the corresponding work should be carried out in accordance with other requirements of this guideline. For the same species of medical devices through clinical trials or clinical use of data obtained by analyzing and evaluating the situation to prove that the medical device is safe and effective.
Declared for registration of the product should first choose and has been approved in the territory of the registration of the same varieties of medical devices for comparison, to prove that they are basically equivalent, that is, declared that the product and the same varieties of medical devices of the differences do not adversely affect the safety and effectiveness of the product. Whether the differences adversely affect the safety and effectiveness of the product should be verified and/or confirmed by the data of the declared product itself. On this basis, clinical literature and clinical experience data of the same variety of medical devices are provided and analyzed and evaluated to complete the clinical evaluation. The guidelines specify the corresponding literature search and screening requirements, literature search and screening program, literature search and screening report format, through the same variety of medical devices clinical trials or clinical use of data obtained from the analysis and evaluation report format.
For products undergoing clinical trials in China, the clinical trials should be conducted in qualified clinical trial organizations in accordance with the requirements of the Code for Quality Management of Clinical Trials of Medical Devices. For imported medical devices undergoing clinical trials outside China, if the clinical trial meets the requirements of relevant Chinese regulations and registration technical guidelines, such as sample size, control group selection, evaluation indexes and evaluation principles, efficacy evaluation indexes, etc., the applicant for registration may submit the clinical trial information submitted to the overseas medical device authorities when the product is listed outside China. The information should at least include the opinion of the ethics committee, clinical trial program and clinical trial report, and the applicant is also required to submit relevant supporting information to demonstrate whether there are ethnical differences in the clinical performance and/or safety of the product. For medical devices listed in the Catalog of Class III Medical Devices Requiring Clinical Trial Approval, clinical trials should be conducted in China.
The guiding principles standardize and unify the requirements for clinical evaluation of imported and domestic medical devices, by distinguishing between different clinical evaluation situations, and reasonably setting the corresponding requirements, improve the relevance of clinical evaluation, scientific, and reduce the burden on the management relative. In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations. In the Chinese people's *** and the State engaged in the development of medical devices, production, operation, use of activities and their supervision and management, shall comply with these regulations.
Legal basis:
"Regulations on the Supervision and Administration of Medical Devices"
Article I In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations.
Article 2 The development, production, operation and use of medical devices and their supervision and management within the territory of the Chinese People's **** and the State shall comply with these Regulations.
Article 3 The food and drug administration department of the state council is responsible for the supervision and management of medical devices nationwide. The relevant departments of the State Council in their respective areas of responsibility for supervision and management of medical devices.
Article 4 The local people's government at or above the county level shall strengthen the leadership of the supervision and management of medical devices in the administrative area, organize and coordinate the supervision and management of medical devices in the administrative area as well as the response to emergencies, and strengthen the supervision and management of medical devices to build capacity and provide protection for the safety of medical devices. The departments of local people's governments above the county level responsible for drug supervision and management are responsible for the supervision and management of medical devices in the administrative area. 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 in their respective areas of responsibility.