Asia Reg Roundup: Philippines Sets Short Reg System Deadline, Vietnam Defers, Malaysia Extends
New regulatory systems for devices are proliferating in the ASEAN and South-East Asia region. Some have set short compliance deadlines that have turned out to be unworkable. Will the Philippines, which in January issued an Administrative Order establishing a new risk-based regulatory system, suffer the same fate? Medtech Insight discussed the issue with local regulatory experts Jack Wong and May Ng.
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Asian Medtech Update: Thai Device Law Latest; National Issues Aired; ASEANMed Seeks Medtech Industry Role At AMDC
This month's Asian Medtech Associations' regulatory networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulations; ASEANMed's aims to represent the regional industry at AMDC; and other ASEAN national updates. This series is hosted by Medtech Insight and sponsored by the Asia Regulatory Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
Medtech regulatory fees in the Philippines are being increased for the first time since 2001. The country's FDA says the new fees will support quality improvements.
Having divested non-medical imaging a year ago, Olympus Corp is putting its foot to the floor in refocusing on its medical portfolio. It has set global ambitions of strengthening its coverage of unmet needs and of playing a major role in reshaping health care delivery.