Announcement on Registration Items for Main Documents of Medical Devices

Announcement of the National Medical Products Administration on the Registration of Medical Device Master Files (No. 36 of 2021)

In order to implement the spirit of the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, and the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" issued by the State Council, further improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, encourage innovation, facilitate medical device manufacturers to select raw materials and key components, and simplify registration and declaration, the following matters are hereby announced regarding the registration of the master files of domestic Class III and imported Class II and Class III medical devices:

1. The content of the medical device master file mainly involves the raw materials of medical devices, etc. The medical device registration applicant shall guide and assist the master file owner to establish the master file in accordance with the relevant requirements of the medical device registration application materials. The medical device registration applicant shall bear full responsibility for the medical devices it has applied for.

2. The registration of master documents cited in applications for registration, change, clinical trial approval, etc. of imported Class II and Class III medical devices (including in vitro diagnostic reagents) submitted by medical device registration applicants within the territory of the People's Republic of China shall be subject to this announcement.

3. The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the Medical Device Evaluation Center) establishes a medical device master file registration platform (hereinafter referred to as the registration platform) and database. The master file owner can submit the master file registration information through the registration platform in accordance with the requirements of this announcement, and obtain the master file registration number after registration. The Medical Device Evaluation Center will review the master file information together after the related medical device submits the relevant registration application.

4. Registration of medical device master files is voluntary. Domestic master file owners can apply for registration on their own. Imported (including Hong Kong, Macao and Taiwan) master file owners should entrust domestic agents to apply for registration. All master file registration materials must be signed and sealed by the master file owner, including the medical device master file registration (update) application form and its accompanying registration materials and technical information. Foreign language documents must also provide simplified Chinese translations (Chinese translations can be signed and sealed by domestic agents).

5. The registration information and signatures of the master file are applicable to the requirements for electronic declaration of medical device registration. After the master file owner or its agent applies for the digital certification certificate (Certificate Authority, CA) used in conjunction with the eRPS system, submit the medical device master file registration application form (Appendix 1) or the medical device master file registration update application form (Appendix 2), the registration information attached to the application form, technical information and other registration information in the electronic declaration system. After the information is successfully submitted, the Medical Device Evaluation Center sends the medical device master file registration receipt (Appendix 3) to the master file owner or its agent. The registration receipt only proves that the master file is archived for inspection and is used for reference in declaration matters such as medical device product registration. The National Medical Products Administration Medical Device Evaluation Center will disclose the master file registration related information (Appendix 4) on its official website in due course for public inquiry.

VI. The requirements for the registration information format of the medical device master file for registration application are shown in Annex 5.

7. When the content of the registered medical device master file changes, the master file owner may apply for an update of the registration information. The application form for the registration and update of the medical device master file is attached in Attachment 2.

8. For specific requirements on medical device master file registration, please refer to the Explanation of Matters Related to Medical Device Master File Registration (Appendix 6).

The drug supervision and administration bureaus of each province, autonomous region, and municipality directly under the central government may carry out the master file registration of domestic Class II medical devices in accordance with actual conditions and with reference to this announcement.

This announcement shall be effective from the date of its release.

Special announcement.