Dynamic China Moves Into The Fast Lane Of Medtech Regulatory Improvements
The Chinese medtech regulatory system was a key theme at the MedTech Summit in June, where regional specialists gave updates on registration timelines and electronic submissions, and signaled how the world’s biggest market-in-waiting is speeding up its regulatory improvements in a bid to become more open and less forbidding for overseas entrants.
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China is quickly expanding its marketing authorization holder scheme from drugs to devices. It is also vowing to reduce medical costs by using more low-cost, domestic consumables, which will have a significant impact on companies.
The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within China’s agencies in issuing guidances, technical standards, and in review updates. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
Inaugural artificial intelligence recommendations from NICE on radiotherapy contouring should allow clinicians to spend more time with patients and on complex cases where AI is not an option. But large language models are not appropriate in all cases, cautions Adrian Sutherland, principal healthcare architect at Endava consultancy.