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Therapeutic Goods Administration proposals say the review of companion diagnostics and their corresponding drugs should be linked.
China’s artificial intelligence-powered health-care ambition takes a new form, a 24-hour health clinic complete with a medicine dispenser that may eventually be coming to a city corner near you. Pharma companies are also continuing to build digital health services in the country as part of the health technology push.
More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.
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).
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight new guidance documents were posted on the tracker since its last update.
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.
Requirements relating to patient cards and information leaflets for all implantable medical devices are based on the new EU medtech rules, but Australia has chosen to implement these earlier to address consumer information gaps.
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