JAPAN: TECHNICAL STANDARDS REVISED FOR SOME CLASS III DEVICES – OCTOBER/NOVEMBER 2023
- 2023-10-20 06:59:35
PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.
了解更多PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.
了解更多As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.
了解更多The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.
了解更多Hong Kong's MDD has announced a few changes in the trial schemes on the acceptance of some reference agencies approval. MDD also announced the regularization of the expedited approval scheme for Class II/III/IV General Medical Devices.
了解更多MDD announced the closing of the ongoing trial scheme for expedited approval of Class II/III/IV General Medical Device Listing Application on 31 December 2021. The limit application for applicants who wish to apply through the trial scheme have been lifted.
了解更多Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.
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