Fasten your seatbelt! Taiwan Medical Device Act and new regulations come into force
In November 2020, we published an article on the draft Medical Device Act (“new Act”) announced by the Taiwan Ministry of Health and Welfare. The new Act is now confirmed...
China Medical Device Regulations – Major Updates
On 18 March 2021, China published its final version of the revised Regulations on the Supervision and Administration of Medical Devices (Order No. 739, an update on Order No. 680)....
Taiwan FDA Unique Device Identifier (UDI) Draft Regulation
Taiwan has recently published a draft regulation of their Unique Device Identifier (UDI) Requirements for Medical Device Labels on 5 November 2020. This regulation will be applicable to all imported...
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...
