China

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New Access to China Medtech market via Greater Bay Area Initiative

By Jenny Lin | 15 February 2021
In June 2019, China accepted a new initiative proposed by the Hong Kong Special Administration Region (SAR) to allow the sale of Hong Kong-registered medical devices and drugs to Hong...
Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

By Jenny Lin | 22 January 2021
Registration of medical devices in China requires a clinical evaluation report (CER) regardless of the device classification. For many, preparing a CER that meets China’s requirements is a daunting challenge...
Sauce

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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Alternative Pathways for Medical Device Market Authorisation

Apr 29, 2021

Fasten your seatbelt! Taiwan Medical Device Act and new regulations come into force

Apr 26, 2021

Cross Border Advisory Merger Opens New Markets for Australian Medtechs

Apr 23, 2021

China Medical Device Regulations – Major Updates

Apr 8, 2021

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

Mar 30, 2021

Technical File Differences Between Medical Devices and IVD Medical Devices

Mar 26, 2021

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