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Asia Pacific

Set Alert for Asia Pacific

Australia Wants To Link Regulatory Review Of CDx And Associated Drugs

Therapeutic Goods Administration proposals say the review of companion diagnostics and their corresponding drugs should be linked.

In Vitro Diagnostics Australia Policy & Regulation

AI-Powered 'Doctor' Adds Fuel To China Digital Health Investment Fire

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.

China Artificial Intelligence

33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

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.

International Europe

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).

Philippines India

Global Medtech Guidance Tracker: October 2018

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.

International Australia

Hong Kong Medtech Regulators Face Need For System 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.

Hong Kong Regulation

Australia Requires Patient Cards With All New Implants From Dec. 1

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.

Australia Policy & Regulation
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