South Korea Roundup: Augmented Reality Device Guidelines, Digital, UDI And IVD Updates
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.
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Asian Medtech Associations Reg Networking: COVID-19 Dominates As Medtechs Seek Return To Normality – Part One
The Asian Medtech Associations Regulatory Networking discussions this month centered on strategies to control COVID-19 in Thailand, Singapore, South Korea, Indonesia and Vietnam. This editorial feature is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy and the Asia Regulatory Professional Association. This is the first of two articles from the discussions.
South Korea, one of the first countries to be hit by the spread of COVID-19 from China, has implemented new standalone IVD regulations.
Part 1 of this month’s Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This feature is hosted by Medtech Insight, the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).