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The Japanese Adverse Drug Event Report (JADER) database is a spontaneous reporting system of drug adverse events which is managed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. [1] It has been available since 2012. [1]
Drug and medical device testing: Scientific review of market authorization applications based on Japanese pharmaceutical law; Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA))
ACCESS CO., LTD. (株式会社ACCESS, Kabushiki-gaisha Akusesu), founded in April 1979 and incorporated in February 1984 in Tokyo, Japan, by Arakawa Toru and Kamada Tomihisa, [1] is a company providing a variety of software for connected and mobile devices, such as mobile phones, PDAs, video game consoles and set top boxes.
This article needs to be updated.The reason given is: there was a significant revision to Japan's Pharmaceuticals and Medical Devices Act (PMD Act) in December 4, 2019 (令和 元 年12月 4日) and certain articles in this revised PMD Act took effect April 1, 2020, September 1, 2020, and August 1, 2021; other articles will take effect Dec. 1, 2022 (see also: https://www.natlawreview.com ...
EU investigates fair access to China's medical device market. Philip Blenkinsop and Ingrid Melander. April 24, 2024 at 10:05 AM. By Philip Blenkinsop and Ingrid Melander.
The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
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