Learned from the current State Food and Drug Administration, the recent drug administration department is about to introduce twoMedical DevicesThe new regulatory policy will guide the registration of innovative medical device products and further simplify the re-registration requirements of 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.

The long time taken for medical device registration has always been an important problem that plagues related industries. Relevant medical device companies have reported that the registration cycle of many projects is longer than the development cycle, resulting in many companies obtaining product registration by buying ready-made products first, and then developing themselves and reissuing various documents. The phenomenon is very unfavorable to the R & D and innovation of medical device companies.

According to reports, the current approval process too much work is an important factor affecting the efficiency of medical device registration. Taking the application for the first registration of category III medical devices in China as an example, only in the technical review and administrative examination and approval links, it is necessary to go through the procedures of examination and approval of more than 10 people respectively, which not only reduces the work efficiency, but also easily causes the responsibility not to be implemented, and also occupies the time limit of substantive examination.

Sun Lei, deputy director of the Medical Device Supervision Department of the Food and Drug Administration, said that the Drug Administration has noticed the relevant problems before and collected many opinions from the industry. Relevant documents will be issued in the near future to simplify the re-registration process of medical devices. Relevant measures include shortening some procedure time and simplifying the approval process. In addition, the previous monitoring summary report of relevant products can also be used as an important basis for applying for re-registration to make the review reasonable implementation, it is expected that the new regulations will effectively improve the problem that medical device re-registration takes too long.

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.

"In order to speed up the registration and approval of innovative medical device products, it is still necessary to introduce the concept of early intervention that has been practiced in the field of drug registration in the future," Sun Lei said. The upcoming guidance document mainly hopes to provide timely guidance, communication and consultation on enterprise R & D in the early stage of medical device product development and clinical research, so as to reduce unnecessary waste of resources and improve R & D efficiency in the early stage, in order to minimize the time required for the review and approval of innovative products.

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.

It is understood that the above-mentioned document countersigning procedures have been basically completed and are expected to be released within this month. In this regard, industry institutions said that whether it is to promote the registration and approval of innovative medical devices or to simplify the re-registration procedures 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.

Wang Lanming, Director of the Medical Device Supervision Department of the Food and Drug Administration, also stated that in the future, information on post-marketing monitoring and quality system supervision should be further used to improve the quality and efficiency of registration, including better implementation based on a more complete post-marketing regulatory system. "Conditional approval" to promote the process of new product research and listing for clinical use.