Asia Reg Roundup: Cybersecurity, China, ASEAN And MDSAP Updates
Executive Summary
China is making additions to its medtech regulatory system, and Southeast Asian nations are making progress towards ratifying the regional Medical Device Directive. Meanwhile, cybersecurity, priority reviews and the Medical Device Single Audit Program are demanding attention regionally and globally, as ARQon consultant May Ng and Asia Regulatory Professional Association (ARPA) secretary Jack Wong report in this Asian regulatory update.
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Regulatory and market access improvements for medtech products were on the agenda at last month's Health Products Regulatory Forum in Singapore. These forward-looking changes are seen by the government and the Health Sciences Authority (HSA) as the medtech sector's contribution to initiatives and aims developed by the Singapore Committee on the Future Economy (CFE).
WannaCry Cybersecurity Alert Shows Medtech Software Must Look Beyond Quick Fixes
Preventing cyberattacks on medical technology occupies the waking thoughts of device software manufacturers, but the global ransomware episode in mid-May shows that companies must also be alive to threat posed to their provider customers.
Asia Reg Roundup: Malaysia, Vietnam & India Speed Ahead In 2017
Progress on ratifying the ASEAN Medical Device Directive (AMDD) continues apace, with some of the Association of Southeast Asian Nations members surging ahead. Malaysia and Vietnam, in particular, are making big efforts to build or strengthen their national regulatory systems foe devices. Also, non-ASEAN state India is taking real steps in a similar direction, say Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng in this latest Asian regulatory update.