The State Food and Drug Administration issued the "Announcement on the Registration Items of the Master File of Medical Devices" on the 12th

On March 12, the State Food and Drug Administration issued a notice on the official website of the "Announcement on the Registration of Medical Device Master Files"
.

The document shows that the announcement is applicable to the registration of the main documents cited in the application items of domestic Class III, imported Class II, and Class III medical devices, changes, and clinical trial approvals

The original text is as follows:

Announcement of the State Food and Drug Administration on the Registration Items of the Master File of Medical Devices (No.
36 of 2021)

Release time: 2021-03-12

In order to implement the spirit of the "Opinions on Deepening the Reform of the Review and Approval System and Encourage Innovation in Drugs and Medical Devices" by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, and the "Opinions on Reforming the Review and Approval System of Drugs and Medical Devices" by the State Council, further improve the review Approval quality, establish a more scientific and efficient review and approval system, encourage innovation, facilitate the selection of raw materials and key components for medical device manufacturers, and simplify the registration application.
Announcement related to document registration is as follows:

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

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 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

       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

       5.
The contents of the main file registration information and signatures are applicable to the relevant requirements for 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

       6.
Please refer to Annex 5 for the requirements for the registration data of the main 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)
.

       All provinces, autonomous regions, and municipalities directly under the Central Government may refer to this Announcement to carry out the registration of the master file of domestic second-class medical devices based on actual conditions
.

       This announcement will be implemented from the date of its release
.

       Hereby announce
.

       annex:

       1.
Application form for registration of master file of medical device

       2.
Application form for registration and update of the master file of medical devices

       3.
Medical device master file registration receipt

       4.
Information related to the registration of the master file of the medical device

       5.
Requirements for the form of registration materials for the master file of medical devices

       6.
Description of matters related to medical device master file registration