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The FDA will issue a new medical device regulatory policy for medical device units or benefit.

Release time:

2018-08-08

The Shanghai Securities News reported that the reporter learned from the current State Food and Drug Administration yesterday that the drug administration will soon introduce two new medical device supervision policies, which will guide the registration of innovative medical device products and further simplify the re-registration requirements for medical devices. Industry insiders said that the introduction of relevant measures will help promote the merger and integration of the medical device industry and benefit the development of innovative medical device enterprises.

(From: China Medical Device Industry Network)

The Shanghai Securities News reported that the reporter learned from the current State Food and Drug Administration yesterday that the drug administration will soon introduce two new medical device supervision policies, which will guide the registration of innovative medical device products and further simplify the re-registration requirements for medical devices. Industry insiders said that the introduction of relevant measures will help promote the merger and integration of the medical device industry and benefit the development of innovative medical device enterprises.

It is reported that the Food and Drug Administration will issue guidance on the registration of innovative medical device products in the near future. It is expected that on this basis, a special approval system will be established for medical device products with major technological innovations and major clinical disease problems to reduce the use of relevant innovative medical device products in regulatory processes. Time.

According to reports, the new guidance document can also provide innovators with a clear and clear regulatory path by formulating technical guidance documents, so as to improve the transparency, certainty and predictability of the review and approval process, so as to promote product research, development and The purpose of the listing process. In this regard, the industry also said that for the current medical device enterprises, the process is clear and more important, with clear and standardized guidance on medical device research and development will play a great role in promoting.

The report said that the above-mentioned document countersigning procedures have been basically completed and are expected to be released within this month. In this regard, the relevant consulting company told reporters that whether it is to promote the registration and approval of innovative medical devices or to simplify the re-registration process of medical devices, leading companies with R & D advantages in the industry will benefit relatively, and relevant measures will further promote industry merger and integration in the future. and further improve the threshold of industrial competition.

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