Thailand Rolls Out IMDRF-Based Risk Classifications For Devices And Diagnostics
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.
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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).
Germany has ramped up its COVID-19 testing capacity to 260,000 per week, and still has a relatively low death rate from the virus. The country's diagnostics industry says it is ready to play its part “24/7.”
The EU Partnership on Health Innovation, a new public private health care research partnership, is in the final drafting phase before its launch under Horizon Europe. In Vivo asked the partnership’s medtech industry lead, Patrick Boisseau, to set out the innovation challenges for participants as they address unmet health care needs in Europe.