In order to standardize the registration and filing management of medical devices and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices". Medical devices sold and used within the territory of the People's Republic of China must apply for registration or go through filing procedures in accordance with the provisions of these Measures. Medical device registration is a process in which the Food and Drug Administration, based on the application of the medical device registration applicant, conducts a systematic evaluation of the safety, effectiveness research and results of the medical device to be marketed in accordance with legal procedures to decide whether to agree to the application. . Medical device filing means that the medical device filer submits filing materials to the food and drug regulatory department, and the food and drug regulatory department archives the submitted filing materials for future reference.
1. Medical device business license application process:
1. Name check;
2. Apply for business license;
3 , apply for a medical device business license;
4. Change the business scope (add Category II and Category III medical device business scope).
2. Materials required for applying for a medical device business license:
1. Product quality supervision and inspection personnel with a college degree or above (including junior college) graduated from relevant medical majors (one of whom is a quality supervisor) Person in charge of testing);
2. Copies of ID cards, graduation certificates, and work resumes of quality supervision and testing personnel; (Teachers from the Food and Drug Administration need to provide the identities of relevant testing personnel when they come to the site for verification and interviews. original certificate and graduation certificate, and be present in person);
3. The business license and medical device production enterprise license of the manufacturer of the medical device sold;
4. Medical device registration certificate and medical device registration form of the counterparty manufacturer of the medical device;
5. Sales authorization letter from the counterparty manufacturer of the medical device being sold.
Legal basis: "Measures for the Registration and Management of Medical Devices"
Article 3 Medical device registration is the process by which the Food and Drug Administration shall, based on the application of the applicant for medical device registration, proceed in accordance with legal procedures. The process of systematically evaluating the safety and effectiveness studies and results of the medical device to be marketed to decide whether to agree to its application.
Medical device filing means that the medical device filing party submits filing materials to the food and drug regulatory department, and the food and drug regulatory department archives the submitted filing materials for future reference.
Article 4 Medical device registration and filing shall follow the principles of openness, fairness and impartiality.