New Access to China Medtech market via Greater Bay Area Initiative
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 Insights for Medical Devices in China
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...
Upcoming update to the Taiwan FDA Medical Devices Act
Taiwan has one of the most enviable healthcare systems in the world - it boasts the number one ranking among 93 countries two years in a row from mid-2018 and...
