Medical devices for the record is a medical device filing to the food and drug supervision and management department to submit the record information, the food and drug supervision and management department of the filing information submitted to the archives for inspection. Article IV medical device registration and filing should follow the principles of openness, fairness and justice. Article 5 The first class of medical devices for the record management. Class II, Class III medical device registration management.
Inside the first class of medical devices for the record, the filing of municipal food and drug supervision and management departments to submit the record information.
The territory of the second class of medical devices by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for review, approval and issue of medical device registration certificate.
The third class of medical devices within the territory of the State Food and Drug Administration to review and approve the issuance of medical device registration certificate.
Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information.
Import of Class II and Class III medical devices by the State Food and Drug Administration for review, approval and issue of medical device registration certificate.
Hong Kong, Macao, Taiwan, the registration of medical devices, for the record, with reference to the import of medical devices. Article VI medical device registrants, filers in their own name to market the product, the product is legally responsible. Article VII food and drug supervision and management departments in accordance with the law and timely release of medical device registration, filing related information. Applicants can inquire about the progress and results of the approval, and the public can access the results of the approval. Article 8 The state encourages the research and innovation of medical devices, and implements special approval for innovative medical devices, promotes the popularization and application of new technology of medical devices, and promotes the development of medical device industry. Chapter II Basic Requirements Article 9 The applicant for registration of medical devices and the filer shall establish a quality management system related to product development and production, and maintain effective operation.
In accordance with the innovative medical device special approval procedures for approval of the domestic medical device application for registration, the sample entrusted to other enterprises, should be entrusted with the corresponding production range of medical device manufacturers; does not belong to the innovative medical device special approval procedures for approval of the domestic medical device application for registration, the sample shall not be entrusted to other enterprises. Article 10 The person who handles the registration or filing of medical devices shall have appropriate professional knowledge and be familiar with the laws, regulations, rules and technical requirements for the registration or filing of medical devices. Article 11 The applicant or the filer to apply for registration or for the record, should follow the basic requirements of safety and effectiveness of medical devices, to ensure that the development process is standardized, all the data is true, complete and traceable. Article XII of the application for registration or for the record information should be used in Chinese. According to the translation of foreign language information should be provided at the same time the original. Citation of unpublished literature, should provide the owner of the data should be licensed to use the documents.
Applicants and filers are responsible for the authenticity of the information. Article XIII of the application for registration or for the record of imported medical devices, should be in the applicant or the filer of the registration or production address in the country (region) has been approved for marketing and sales.
The applicant or the filing of the applicant's place of registration or production address in the country (region) is not the product as a medical device management, the applicant or the filing of the applicant needs to provide the relevant documents, including the place of registration or the production address of the country (region) to authorize the sale of the product on the market documents. Article XIV of foreign applicants or filers should be set up in China through its representative organizations or designated Chinese enterprises as agents, with foreign applicants or filers to carry out the relevant work.
In addition to handling the registration or filing of medical devices, the agent shall also undertake the following responsibilities:
(1) liaison with the corresponding food and drug administration department, overseas applicant or filer;
(2) truthfully and accurately convey to the applicant or filer the relevant regulations and technical requirements;
(3) collect post-market Medical device adverse event information and feedback to the foreign registrant or filer, and at the same time report to the appropriate food and drug supervision and management departments;
(d) coordination of product recall of medical devices after listing, and report to the appropriate food and drug supervision and management departments;
(e) other product quality and after-sales service related to the joint responsibility. Chapter III Product Technical Requirements and Registration and Inspection Article 15 The applicant or the filer shall prepare to register or record the product technical requirements of medical devices. Class I medical device product technical requirements by the filer for the record submitted to the food and drug supervision and management department. Class II, Class III medical device product technical requirements by the food and drug supervision and management department in the approval of registration to be approved.
Product technical requirements mainly include the performance indicators and test methods for finished medical devices, of which the performance indicators refer to the functionality of the finished product that can be objectively determined, safety indicators and other indicators related to quality control.
Medical devices marketed in China should comply with the technical requirements of the products approved or filed by the registration.