State Food and Drug Administration issued a new regulation of medical devices
State Food and Drug Administration issued a new regulation of medical devices
Date：2021-12-01 16:20
In July 18th, we learned from the State Food and drug administration, the drug administration department recently forthcoming two medical device regulatory deal, respectively, for the innovation of medical equipment products registered for guidance, and further simplify the medical re registration requirements. Insiders said that after the introduction of relevant measures will help promote mergers and acquisitions of the medical device industry, more conducive to the development of innovative medical devices.
Medical device registration time consuming is always an important problem in related industries, related medical equipment enterprises are reflected, many items of registration period longer than the period of development, leading to the emergence of many enterprises to obtain product registration by buy ready-made products, then its development and re submit the documents of the phenomenon, is not conducive to innovation medical equipment enterprises.
According to reports, the current approval process is too much work is an important factor affecting the efficiency of medical device registration. In the territory of third types of medical equipment for the first time application for registration as an example, only in the technical evaluation and administrative approval procedures currently requires more than 10 people respectively through the review, the audit procedures, not only reduces the work efficiency, and easy to cause the responsibility is not implemented, crowding out the substantive examination work time.
Sun Lei, deputy director of the food and Drug Administration of medical device supervision department told reporters that the administration had already noticed the problem, from the industry and collected many views, recently the upcoming release of the relevant documents on the medical re registration procedures are simplified, the measures include shortening of program time and simplify the approval process, in addition, related products previously the monitoring report can also be used as an important basis for re registration to make the examination more reasonable implementation is expected in the future, the new regulations will effectively improve medical time-consuming re registration.
At the same time, the reporter also learned that the food and Drug Administration recently introduced innovative medical device product registration guide, the future is expected to on the basis of major technological innovations and the establishment of special approval system to solve major problems of clinical disease medical products, medical equipment to reduce the related regulations for product innovation process time.
"To speed up the innovation of medical device product registration approval, the future will advance into practice has been carried out in the concept of drug registration in the field," Sun Lei told reporters that the guidance documents will be issued mainly in the hope that through the development of medical device products and clinical research of early, provide timely guidance, communication and consultation on enterprise development, in order to reduce the unnecessary waste of resources in the early stage, improve the efficiency of research and development, to try to shorten the time required for the review and approval of innovative products.
According to reports, the new guidelines can through the development of technical guidelines and regulations, provide a clear path to clear as innovators, so as to improve the review and approval process of transparency, certainty and predictability, to promote product research and development and the purpose of the listing process. In this regard, the industry also said that for the current medical device companies clear process is more important, with a clear guide to the specification of medical device research and development will play a significant role in promoting.
Reporters learned that the current document sign program has been basically completed, is expected to be released in this month. This advisory company told reporters, whether it is to promote the innovation of the medical device registration or re registration procedures simplified medical devices, leading companies in the industry has developed the advantages of relative benefit, relevant measures will further promote the industry merger integration, and further improve the industry competition threshold.
The food and Drug Administration Medical Devices Regulatory Secretary Wang Lanming also said that the future should further use after the listing of the safety monitoring and system of quality supervision and other aspects of information to improve the quality and efficiency of registration, including the relatively perfect system of supervision on the market can better implement the "conditional approval" based on, in order to promote the new product research and market for clinical applications process.
- China Medical Science and technology network
Medical device registration time consuming is always an important problem in related industries, related medical equipment enterprises are reflected, many items of registration period longer than the period of development, leading to the emergence of many enterprises to obtain product registration by buy ready-made products, then its development and re submit the documents of the phenomenon, is not conducive to innovation medical equipment enterprises.
According to reports, the current approval process is too much work is an important factor affecting the efficiency of medical device registration. In the territory of third types of medical equipment for the first time application for registration as an example, only in the technical evaluation and administrative approval procedures currently requires more than 10 people respectively through the review, the audit procedures, not only reduces the work efficiency, and easy to cause the responsibility is not implemented, crowding out the substantive examination work time.
Sun Lei, deputy director of the food and Drug Administration of medical device supervision department told reporters that the administration had already noticed the problem, from the industry and collected many views, recently the upcoming release of the relevant documents on the medical re registration procedures are simplified, the measures include shortening of program time and simplify the approval process, in addition, related products previously the monitoring report can also be used as an important basis for re registration to make the examination more reasonable implementation is expected in the future, the new regulations will effectively improve medical time-consuming re registration.
At the same time, the reporter also learned that the food and Drug Administration recently introduced innovative medical device product registration guide, the future is expected to on the basis of major technological innovations and the establishment of special approval system to solve major problems of clinical disease medical products, medical equipment to reduce the related regulations for product innovation process time.
"To speed up the innovation of medical device product registration approval, the future will advance into practice has been carried out in the concept of drug registration in the field," Sun Lei told reporters that the guidance documents will be issued mainly in the hope that through the development of medical device products and clinical research of early, provide timely guidance, communication and consultation on enterprise development, in order to reduce the unnecessary waste of resources in the early stage, improve the efficiency of research and development, to try to shorten the time required for the review and approval of innovative products.
According to reports, the new guidelines can through the development of technical guidelines and regulations, provide a clear path to clear as innovators, so as to improve the review and approval process of transparency, certainty and predictability, to promote product research and development and the purpose of the listing process. In this regard, the industry also said that for the current medical device companies clear process is more important, with a clear guide to the specification of medical device research and development will play a significant role in promoting.
Reporters learned that the current document sign program has been basically completed, is expected to be released in this month. This advisory company told reporters, whether it is to promote the innovation of the medical device registration or re registration procedures simplified medical devices, leading companies in the industry has developed the advantages of relative benefit, relevant measures will further promote the industry merger integration, and further improve the industry competition threshold.
The food and Drug Administration Medical Devices Regulatory Secretary Wang Lanming also said that the future should further use after the listing of the safety monitoring and system of quality supervision and other aspects of information to improve the quality and efficiency of registration, including the relatively perfect system of supervision on the market can better implement the "conditional approval" based on, in order to promote the new product research and market for clinical applications process.
- China Medical Science and technology network