1. The content of the medical device master file mainly involves medical device raw materials. The medical device registration applicant shall guide and assist the owner of the master file to establish the master file in accordance with the relevant requirements of the medical device registration application materials. Applicants for medical device registration shall be fully responsible for the medical devices they declare.
2. The main documents cited in the registration, modification, and clinical trial approval of imported Class II, Class III and Class III medical devices (including in vitro diagnostic reagents) imported by the applicant for medical device registration within the territory of the People's Republic of China The registration is applicable to this announcement.
3. The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the Device Review Center) establishes a medical device master document registration platform (hereinafter referred to as the registration platform) and a database. The owner of the master document can submit the master document registration information through the registration platform according to the requirements of this announcement, and obtain the master document registration number after registration. The Approval Center will review the main documents together after the related medical device has filed the relevant application for registration.
4. The registration of the master file of the medical device is voluntary. The owner of the domestic master file can apply for registration by himself. The owner of the master file of imports (including Hong Kong, Macao and Taiwan) should entrust a domestic agency to apply for registration. The registration materials of the master file must be signed and sealed by the owner of the master file, including the medical device master file registration (update) application form and its accompanying registration materials and technical materials. Documents in foreign languages must also be translated into simplified Chinese (the Chinese translation can be signed by the domestic agency).
5. The contents of the main file registration information and signature are applicable to the relevant requirements of the electronic declaration of medical device registration. After the owner of the master file or its agency has applied for the Certificate Authority (CA) used in the eRPS system, submit the medical device master file registration application form (Annex 1) or the medical device master file registration update in the electronic reporting system The application form (Attachment 2) and the registration materials, technical materials and other registration materials attached to the application form. After the materials are successfully submitted, the Approval Center will send the medical device master file registration receipt (attachment 3) to the owner of the master file or its agency. The registration receipt only proves that the main document is archived for inspection, and is used for reference in the declaration items such as medical device product registration. The Medical Examination Center of the State Food and Drug Administration will publish the main file registration related information (Annex 4) on its official website in due course for public inquiries.
6. Please refer to appendix 5 for the registration data form requirements of the master file of the medical device to be registered.
7. When the content of the registered medical device master file changes, the owner of the master file can apply for an update of the registration information. See Annex 2 for the application form for registration and update of the medical device master file.
8. For the specific requirements for the registration of the main file of medical devices, please refer to the "Description of Matters Related to the Registration of the Main File of Medical Devices" (Annex 6).
The drug administrations of provinces, autonomous regions, and municipalities directly under the Central Government may refer to this announcement to carry out the registration of the domestic second-class medical device master file according to the actual situation.
This announcement will be implemented from the date of its release.
National Food and Drug Administration
please clik this link to see the original announcement: https://www.cmde.org.cn/CL0004/22654.html