1. Submit registration application: the applicant submits the prepared registration application materials to the corresponding medical device regulatory agency and pays the corresponding registration fee. Applicants need to ensure the completeness and accuracy of the application materials to avoid delaying the approval process;
2. preliminary examination and technical evaluation: the medical device regulatory agency will conduct preliminary examination of the application materials, including the evaluation of technical documents and clinical trial data, to confirm whether they meet the registration requirements. The safety, effectiveness and performance of medical devices will be strictly evaluated;
3. On-site inspection: In some cases, the medical device regulatory agency may conduct on-site inspection to verify the authenticity and validity of the technical documents and clinical trial data provided by the applicant. On-site inspection may include the production facilities, quality management system and implementation of the manufacturer;
4. approval decision: according to the results of preliminary examination, technical evaluation and on-site inspection, the medical device regulatory agency will make an approval decision and decide whether to approve the application for registration of medical devices. The approval decision may need to go through multiple rounds of review and approval process, which may take a long time;
5. issuance of registration certificate: if the application for registration of a medical device is approved, the medical device regulatory agency will issue a registration certificate to confirm that the medical device has obtained the registration qualification. The registration certificate usually includes the registration number, registration validity period, registration scope and other information of the medical device, which is used as a certificate for the legal sale and use of the medical device.
Requirements for medical device registration certificate:
1. The products to be registered have been listed in the latest version of the Classification Catalogue of Medical Devices;
2. The applicant shall be an enterprise registered according to law;
3. The applicant establishes a quality management system related to product development and production, and keeps it running effectively;
4. When applying for registration, the applicant shall follow the basic requirements for the validity of medical devices, and ensure that the development process is standardized and all data are true, complete and traceable.
to sum up, the registration certificate of medical devices is a necessary certificate for the marketing, sale and use of medical devices, and obtaining the registration certificate of medical devices requires a series of steps, including preparing technical documents, conducting clinical trials, submitting registration applications, reviewing and approving. Applicants need to carefully understand and abide by relevant laws and regulations to ensure the smooth application for registration of medical devices. At the same time, applicants with medical device registration certificates need to carry out follow-up supervision and management, including regular reports, quality management system and so on.
Legal basis:
Article 4 of the Measures for the Administration of Registration and Filing of Medical Devices
National Medical Products Administration is in charge of the management of medical device registration and filing nationwide, responsible for establishing the management system and system of medical device registration and filing, organizing the review and approval of domestic Class III and imported Class II and III medical devices according to law, filing of imported Class I medical devices and related supervision and management, and supervising and guiding the registration and filing of local medical devices.