Reform

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Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…

By Arthur Brandwood | 30 March 2019
Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...
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NZ Makes it Formal – Medical Devices Reform in The Land of the Long White Cloud

By Arthur Brandwood | 28 March 2019
New Zealand has always been a relaxed sort of place – and that included the regulation of medical devices which up till now has been limited to a simple notification...
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China update – regulation with a European sauce?

By Arthur Brandwood | 7 August 2018
CFDA continues to propose more changes to medical device regulation, and as ever the agency looks to international practices and seeks to weave them in to China requirements. A recent...

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Recent Posts

China Medical Device Regulations – Major Updates

Apr 8, 2021

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

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Technical File Differences Between Medical Devices and IVD Medical Devices

Mar 26, 2021

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

Mar 8, 2021

Hitting the Accelerator

Mar 4, 2021

Prescription Medicine Pathways

Feb 25, 2021

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