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The medical devices regulatory system is based on regulations issued by the State Council, NMPA orders and NMPA documents that provide detailed rules for medical device registration and licensing practice. Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard (YY ...
The Center for Devices and Radiological Health ( CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical ...
"FDA Classification of Medical Devices". U.S. Food and Drug Administration. 22 October 2020. "FDA Medical Device Registration and Listing". U.S. Food and Drug Administration. 30 September 2022. "FDA Overview of Medical Device Regulation". U.S. Food and Drug Administration. 4 September 2020.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as premarket notification, PMN, or 510(k).
The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met to discuss the benefits and risks of the test and vote on whether it’s safe and effective.
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