Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018
The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
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Medtech industry representatives from Thailand, Myanmar, Indonesia, Singapore and the Philippines gave updates on regulatory actions being taken to control COVID-19 and other regulatory initiatives at local and ASEANMed level during a roundtable session.
Thailand has opted to align with IMDRF principles on the classification of devices. The change also brings the Thai FDA into line with Asean Medical Device Directive principles.
Speed and efficiency are apparently on the minds of Hong Kong's regulators, who have proposed to shorten approval times for medical device registrations, and are considering granting earlier approvals, subject to certain criteria. Stakeholders are showing guarded optimism in early responses.