Announcement of the State Food and Drug Administration on the registration matters of the master doc

发表时间:2021-03-22 15:00

For the implementation of the general office of the central committee of the communist party of China, The General Office of the State Council "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" and the State Council on the reform of the drug review of medical equipment examination and approval system of opinion "spirit, to further improve the quality of medical apparatus and instruments for examination and approval of the review, a more scientific and efficient review of examination and approval system, encourage innovation, convenient medical device manufacturing enterprise choosing raw materials and key components, simplify the registration declaration, will now in the third class and import category ii and class iii medical devices main document registration matters related to notice the following:

I. Contents of the main document of medical devices mainly involve raw materials of medical devices, etc. The medical device registration applicant shall guide and assist the owner of the master document to establish the master document in accordance with the relevant requirements of the medical device registration application materials. The medical device registration applicant is fully responsible for the medical device he or she has declared.

2. This Announcement shall be applicable to the registration of master documents cited in the application matters of the import of Category II, Category III and Category III medical devices (including in vitro diagnostic reagents) within the People's Republic of China, such as registration, alteration, clinical trial approval and so on.

III. The Medical Device Technical Evaluation Center of the National Medical Products Administration (hereinafter referred to as the Center) shall establish a medical device main document registration platform (hereinafter referred to as the registration platform) and database. The owner of the master document can submit the master document registration information according to the requirements of this Announcement through the registration platform, and obtain the master document registration number after registration. The instrument examination center shall review and evaluate the main documents together with the related application for registration of the associated medical device.

IV. The registration of the master document of the medical device is a voluntary act. The owner of the domestic master document can apply for registration by himself. The owner of the master document of import (including Hong Kong, Macao and Taiwan) shall entrust a domestic agent to apply for registration. The master document registration information shall be signed and sealed by the master document owner, including the medical device master document registration (update) application form and the accompanying registration data and technical data. The documents in foreign languages should also be translated into simplified Chinese (the Chinese translation can be signed and sealed by the domestic agency).

V. The registration information and signature of the main document are applicable to the electronic declaration requirements of medical device registration. Main document owner or its agent claims for eRPS system supporting the use of digital certificates, Certificate Authority, CA), after submit medical devices in electronic declaration system main document registration application form (appendix 1) or medical device registration of the main document update application form (attachment 2), the attached application form to register information, technical data and other registration information. After the data submission is successful, the instrument audit center will send the registration receipt of the master document of the medical device to the master document owner or its agent (attachment 3). Registration receipt only certifies that the main document is archived for reference for medical device product registration and other declaration matters. The Center for Inspection and Approval of the State Food and Drug Administration will publish the registration information in the main document (Annex 4) on its official website in due time for the convenience of public inquiry.

VI. Please refer to Appendix 5 for the form of registration information of the main document of medical device for registration.

VII. When the content of the registered medical device master document changes, the owner of the master document can apply for the update of the registration data. Please refer to Attachment 2 for the update form of medical device master document registration.

VIII. The specific requirements for the registration of master documents of medical devices are detailed in the Instructions on Relevant Matters for the Registration of Master Documents of Medical Devices (Annex 6).

The drug regulatory administrations of all provinces, autonomous regions and municipalities directly under the Central Government may, according to the actual situation and in accordance with this Announcement, carry out the main document registration items of Category II medical devices within China.

This Announcement shall come into effect as of the date of promulgation.

Download the attachment

1. Application Form for Medical Device Master Document Registration

2. Medical device master document registration and update application form

3. Registration receipt of medical device master document

4. Medical device master document registration related information

5. Requirements on the form of registration data for master documents of medical devices

6.Instructions on the matters related to the master document registration of medical devices

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