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时间:2023-3-20 15:54:20来源:本站原创作者:佚名点击:

To all institutions concerned,
The National Medical Products Administration of China (NMPA) issued the Announcement on the Registration Matters of Medical Device Master Files (No. 36 of 2021) in March 2021, and the Center for Medical Device Evaluation, NMPA (hereinafter referred to as the “CMDE”) has established a medical device master file registration platform and database and publicizes information related to the registration of master files on the CMDE website to facilitate inquiries by the public.

According to the registration and use of medical device master files, the related matters are hereby clarified as follows:

I. Medical device master files are a form of technical data, filed directly to the medical device regulator by the owners and used to authorize registration applicants of medical device products in the application for medical device registration and other matters. Registration of medical device master files is a voluntary act.

II. The content of medical device master file registration mainly involves medical device raw materials, etc. The medical device master file system applies to the registration of master files quoted by medical device registration applicants in their applications in China for the registration, changes, clinical trial approval, etc. of imported Class II and Class III and domestic Class III medical devices (including in vitro diagnostic reagents). Medical products administrations in provinces, autonomous regions and municipalities directly under the Central Government can conduct registration of master files of domestic Class II medical devices according to the actual situation and with reference to this Announcement.

III. The medical device master file system aims to achieve regulatory science. The system can solve bottlenecks in registration applications and improve review and approval efficiency. The system gives a positive solution to problems currently facing the medical device industry and is in line with international practice. The system facilitates medical device producing enterprises to select raw materials and key components and simplifies registration applications. Further, the principles of voluntariness and confidentiality of master file data registration are suited to China’s specific conditions and are highly practicable and can well protect the intellectual property rights of the master file owners. The medical device master file system also serves the country’s major strategic needs, contributes to the solution of bottlenecks and stimulates innovation in medical devices and related fields so that innovation achievements can benefit people.

IV. Medical device registration applicants should guide and assist master file owners in establishing the master files according to the relevant requirements for medical device registration application data and should take full responsibility for the medical devices they apply for. Master file owners can submit the master file registration data as required in this Announcement via the registration platform and obtain the master file registration numbers after registration. The CMDE will review the master file data together with the registration applications for the associated medical devices. Therefore, the publicity of related master file registration information only represents the registration of the content of related medical device master files, instead of the passing of technical reviews of the related content of medical device master files (including the name of master files) or the application of related raw materials in the marketed medical devices.

National Medical Products Administration
January 18, 2023

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