Next ASEAN Device Committee Meeting Looms, But National Regs Top Priorities
Asian Medtech Associations Regulatory Networking Series
Executive Summary
New medtech regulations in Singapore, a new medtech law in the Philippines, and another deferral of Act 737 in Malaysia were the focus of the Asian Medtech Associations Regulatory Networking discussions this month. In a break from the usual focus, there was also an update on the EU MDR and preparations for Brexit from the UK Association of HealthTech Industries (ABHI). This series is hosted by Medtech Insight and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), and the Asia Regulatory Professionals Association (ARPA).
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Medtech companies' chance to comment on the final draft of amendments to Vietnam's medical device regulations closed in mid-June. The Vietnam Ministry of Health released a translation of the draft to allow multinational companies and other foreign stakeholders full access to the ongoing debate on extending the deadline to the end of 2019, as proposed by industry in the latest exchanges.
Singapore Updates Guidance On Labeling, Essential Principles, Change Notification And Registration
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Singapore Improves Time To Market For Lower-Risk Devices
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