Recently, the drug regulatory department will soon introduce two new regulations for medical device supervision, which will guide the registration of innovative medical device products and further simplify the requirements for re-registration of medical devices. According to industry insiders, the introduction of relevant measures will help promote the integration of medical device industry and make it more conducive to the development of innovative medical device companies.
The long time-consuming registration of medical devices has always been an important problem that has plagued related industries. Relevant medical device companies have indicated that the registration cycle of many projects is longer than the development cycle, which has led many companies to obtain products by buying ready-made products first. Registration, and then the development of their own and the replacement of various documents, is very unfavorable for the development and innovation of medical device companies.
Too much work in the current approval process is an important factor affecting the efficiency of medical device registration. Taking the application for the first registration of the third type of medical devices in China as an example, only the review and review procedures of more than 10 people are required in the technical review and administrative examination and approval, which not only reduces the work efficiency, but also easily leads to the failure to implement duties. It also squeezed the time limit for substantive review work.
The drug regulatory department has already noticed relevant issues and collected many opinions from the industry. The relevant documents will be released soon to simplify the medical device re-registration process. The relevant measures include shortening part of the program time and simplifying the approval process. In addition, related products have been The monitoring summary report can also be used as an important basis for applying for re-registration to make the review more reasonable. It is expected that the new regulations in the future will effectively improve the long-term problem of re-registration of medical devices.
At the same time, the reporter was also informed that the Food and Drug Administration will introduce innovative medical device product registration guidance in the near future. In the future, it is expected to establish a special approval system for medical device products with major technological innovations and major clinical disease problems to reduce related innovative medical devices. The time the product is used in the regulatory process.
"In order to speed up the registration and approval of innovative medical device products, it is necessary to introduce the concept of early intervention in the field of drug registration in the future," Sun Lei told reporters that the forthcoming guidance documents mainly hope to pass the development of medical device products and clinical research. In the early stage, provide guidance, communication and consultation on enterprise R&D in a timely manner to reduce unnecessary waste of resources and improve R&D efficiency in the early stage, in an effort to shorten the time required for review and approval of innovative products.
The new guidance document can also provide a clear and clear regulatory path for innovators by developing technical guidance documents to improve the transparency, certainty and predictability of the review and approval process to facilitate product research and development and marketing. the goal of. In this regard, the industry also said that for the current medical device companies, the process is clear and more important, with clear and standardized guidance will greatly promote the development of medical devices.
The above document signing procedures have been basically completed and are expected to be released this month. The relevant consulting company told reporters that whether it is to promote the registration of innovative medical devices or to simplify the process of re-registration of medical devices, the leading companies with R&D advantages in the industry will benefit relatively, and the relevant measures will further promote mergers and acquisitions in the future, and further Raise the threshold of industrial competition.
In the future, we should further use the information of post-marketing safety monitoring and quality system supervision to improve the quality and efficiency of registration, including better implementation of “conditional approval†based on a better post-marketing supervision system to promote new product research. And the process of marketing for clinical use, etc.
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