Medical Device Production Supervision Information Platform Promotion Conference Held in Beijing
On December 27, the work promotion meeting of the medical device production supervision information platform (hereinafter referred to as the supervision platform) was held in Beijing. The purpose of the conference is to promote the construction of a medical device production supervision information platform, solve the problems in the use and docking of the system, further improve the level of regulatory informationization, innovate the medical device supervision means, and explore the "smart supervision" of medical devices.
At the meeting, the responsible comrades of the Information Center of the State Drug Administration introduced the basic background of the supervision platform construction, content, project progress, and functional characteristics; the person in charge of the system construction unit explained and demonstrated the system operation on site; some provincial-level trials of the platform The relevant personnel of the information department of the China Food and Drug Administration and some of the provincial drug supervision and administration bureaus that are about to be connected have discussed and exchanged the operation and use of the supervision platform.
The medical device production supervision information platform is based on the integration of the entire life cycle of medical devices and relevant data of manufacturing enterprises, and strives to improve the informationization level of various inspection services and achieve comprehensive management of inspectors. The platform has been trial run in 21 provincial drug regulatory bureaus and passed the final acceptance. Relevant construction work is progressing steadily as planned and will be officially launched.
Giving full play to the advantages of informatization to enhance supervision capabilities is a practical need for supervision. To do a good job of regulatory informatization, the person in charge of the Medical Device Supervision Department of the State Drug Administration pointed out that the construction of a regulatory platform aims to break the silos of data, build electronic regulatory archives, and achieve the interconnection and sharing of basic and regulatory information in different dimensions and at different levels. . Provincial drug regulatory departments shall take effective measures to vigorously promote the use and docking of medical device production supervision platforms, and push the supervision data in a timely, accurate, and complete manner to achieve the good operation of the platform and provide technical support for supervision; it shall be combined with medical device registration The pilot work of the human system, researching new methods and methods of smart supervision, and encouraging provincial drug regulatory bureaus to continue to explore the field of "smart supervision" of medical devices based on local regulatory practices; to strengthen horizontal and vertical interconnection and build national medical device supervision "One game of chess" makes full use of information technology to strengthen communication and collaboration, implement supervision responsibilities, eliminate supervision blind spots, and eliminate security risks.
As a medical device automation assembly equipment manufacturer, Dongguan Nanfang Lijin Machinery Co., Ltd. has been paying attention to the release of national policies, industry trends and other 澳门现金娱乐网投. If such reproduced 澳门现金娱乐网投 violates your rights, please 澳门现金娱乐网投 in time. We Will be removed from the shelf in time.
News source: China Medical News Thank you!