Time : 2021-03-17
Source : CIRS
Author : Demi
According to the medical device review requirements, various researches are required during the registration and application of medical device products, such as material chemical characterization, stability, process research, etc. When conducting medical device product research, some items, especially the chemical characterization of materials, are closely related to raw materials, and it is often necessary to obtain information on the composition and process of raw materials during research. Due to the need for technical confidentiality, it is difficult for medical device raw material suppliers to provide this information to medical device manufacturers in detail, which creates certain difficulties for the research on the final product of medical devices. At the same time, for medical devices that use the same raw materials, some research projects are the same. Research by the medical device manufacturer on its own also causes a waste of resources and the problem of repeated submission of data.
In order to 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 application, the National Instruments Review Center issued the "About The Notice of Publicly Soliciting Opinions on the Registration Items of the Medical Device Master File. After in-depth investigations by the State Food and Drug Administration and after fully listening to all opinions, the “Announcement on the Registration of the Medical Device Master File” (hereinafter referred to as the “Announcement”) was issued in 2021. ").
The content of the medical device master file mainly relates to the medical device raw materials, and the medical device raw material suppliers are voluntarily registered. When the medical device applicant needs to use the main document in the application of product listing registration, the owner of the master file shall issue an authorization letter to the medical device applicant, and the medical device applicant shall replace the registered master document with the authorization letter as part of the application materials data. Therefore, the release of the "Announcement" avoids the repeated submission and repeated review of technical data when different medical devices refer to the same master file, and shortens the time of the registration process. At the same time, it also meets the technical confidentiality requirements of raw material suppliers, and material related information does not need to be directly displayed to medical device manufacturers.
The establishment of a medical device master file registration system is conducive to the registration of medical device components containing complex components. Taking "silicone rubber raw materials" as an example, silicone rubber can be used as raw materials for plastic filling materials, ureteral stents and other medical device components. Such medical devices need to undergo biological tests such as cytotoxicity, intradermal irritation, and sensitization. If the supplier of silicone rubber has applied for the master file of the company’s silicone rubber raw materials, when the same master file is used for different medical devices, Regulators can review the registered master files based on the power of attorney, which can avoid repeated submissions and repeated reviews of technical data.