The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more
China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
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Asia ,
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Drug Pricing ,
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Food and Drug Administration (FDA) ,
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Medical Devices ,
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UK Brexit
A local regulator in Shanghai has recently fined a domestic medical device company for commercial bribery after determining that the company had unduly influenced a group of seven physicians when it paid them speaking fees to...more
The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more