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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Prescription Medicine Pathways

Feb 25, 2021

Transition Plan and Regulatory Changes for Software as Medical Devices

Feb 18, 2021

“How Irritating!” A new paradigm for irritation testing.

Feb 17, 2021

New Access to China Medtech market via Greater Bay Area Initiative

Feb 15, 2021

Transition plan from Custom device to Patient-matched

Feb 11, 2021

Provisionally yours

Jan 27, 2021

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