Jenny Lin


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

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...
Taipei, Taiwan

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...

What you need to know about disinfectants in Australia

In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...

Make your transition from MDD to MDR – White Paper

With less than one year remaining for the transition to the Medical Device Regulation (MDR), this white paper takes a look at the key areas to be addressed for manufacturers...


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