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The long awaited and wide-ranging Opinions on Reforming the Review and Approval Process for Drugs and Medical Devices (the 'Opinions'), were recently issued by China's State Council, and set out a series of measures ...
The effect of the ruling is that the Cosmetic Regulation must be interpreted such that contact lenses marketed purely to alter the user's appearance (rather than to correct vision) will not be within its scope even if ...
This update discusses the most recent development in this saga: the decision of the Court of Appeal of Aix-en-Provence (delivered on 2 July 2015) and its implications.
According to a recent announcement by the China Food and Drug Administration (the 'CFDA'), pharmaceutical and medical device manufacturers should in the future expect regular surprise inspection visits from officials.
he Secretary for Food and Health has stated that the Hong Kong government (the Administration), will soon complete a study on how to regulate high-risk medical devices. It is expected that the proposed regulations will ...
On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...
If an app is considered to be a diagnostic and/or therapeutic tool, the app is no longer "just an app", it is to be regarded as a "medical device", which gives rise to the imposing of certain legal obligations.