Malaysian device system targets total life cycle regulation
This article was originally published in Clinica
Executive Summary
Malaysia’s one-year transition to a new risk-based medical device regulatory system – founded in GHTF concepts and designed to facilitate trade as well as ensuring quality and safety – is well under way. The first deadline (compliance with Act 738 - Medical Device Establishment Act) ended on 1 July 2014. Medical Device Authority (MDA) chief executive Zamane bin Abdul Rahman outlined the new regulatory requirements, and who is affected, at the recent Informa Life Sciences Asia Pacific conference