GDP And UDI On List Of Regulatory Changes Under Taiwan Medical Device Act
Taiwan’s Medical Device Act was enforced on 1 May, bringing changes to good distribution practice and laying the foundation for UDI regulations.
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An end-of-year flurry of regulatory activity in the Asian medtech markets has kept industry on its toes, with initiatives in China, Taiwan and Korea, among other regions. But as Asia Regulatory Professional Association (ARPA) Secretary Jack Wong and ARQon consultant May Ng observe in this December update for Medtech Insight, governments and companies in certain markets might benefit from a little more pressure in view of the regulatory tasks they face.
The practice of telehealth got the impetus it had long needed during the pandemic, as experiences in Czechia and neighboring economies in eastern Europe show in a regional roundup by Kinstellar.
The devices regulator has sought private sector input in updating AR/VR guidelines, but needs to do more on telemedicine integration. Mixed experiences are reported on UDI and the new IVD regulation.