Symposium on the Implementation of Unique Identification of Medical Devices Held in Beijing
Release Time:
2022-07-18
On the afternoon of July 18th, hosted by the Medical Device Registration Management Department of the State Drug Administration and co organized by the Medical Device Standards Management Center and Information Center, the 2022 National Medical Device Safety Promotion Week was held& mdash; The symposium on the implementation of unique identification of medical devices was held in Beijing. The relevant person in charge of the Medical Device Registration Management Department of the National Drug Administration delivered a speech. Representatives of relevant medical device production, operation enterprises, and medical institutions introduced the implementation experience of unique identification for medical devices. The provincial drug regulatory department introduced the promotion of the implementation of unique identification for medical devices in this province (city). The Information Center of the National Drug Administration and the Medical Device Standard Management Center respectively introduced the construction of unique identification databases Relevant standards and technical tracking research status, etc
The unique identification of medical devices is their ID card. Assigning an ID card to each medical device, achieving transparency and visualization in all aspects of production, operation, and use, and improving product traceability, is an important lever for innovation in medical device regulatory methods and improvement of regulatory efficiency. It will play a positive role in strictly adhering to the bottom line of medical device safety and assisting the high-quality development of the medical device industry
In 2019, the National Drug Administration issued the "Rules for the Unique Identification System of Medical Devices". In July of the same year, pilot work was officially launched and the construction of relevant information systems was promoted. In September 2020, the National Drug Administration, the National Health Commission, and the National Medical Insurance Administration jointly issued the "Announcement on Deepening the Pilot Implementation of the First Batch of Medical Device Unique Labeling Work", clarifying that starting from January 1, 2021, the first batch of 69 varieties of medical devices in 9 major categories will officially implement unique labeling. In July 2021, the National Drug Administration, the National Health Commission, and the National Medical Insurance Administration jointly issued a notice on the implementation of the second batch of unique labeling for medical devices, clarifying that on the basis of the first batch of implementation, other third class medical devices (including in vitro diagnostic reagents) will be included in the scope of the second batch of implementation, and will be officially implemented from June 1, 2022. Over the past three years, with the strong support and joint efforts of all parties, various work has been carried out in an orderly manner and achieved good results
During the discussion, representatives of participating enterprises and medical institutions had in-depth communication with regulatory experts, discussing and exchanging the confusion and difficulties in the implementation of unique identification for medical devices. Suggestions were made on the implementation varieties and transition period of the third batch of unique identification, and suggestions were provided for the improvement of policies and standards related to the unique identification of medical devices
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