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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