Malaysia To Phase In Medical Device Registration Process To Avoid Backlash

Malaysia will ease into a new law requiring all medical devices be registered as the country ramps up oversight of its biomedical sector.

KUALA LUMPUR – Malaysia’s Medical Device Authority has taken a cue from Singapore about how not to implement a law requiring the registration of all medical devices, noting that the usually efficient city-state ran into a backlash from doctors and hospitals by not offering enough time for a phase-in period and limiting exemptions.

Two laws passed late in 2012 lay out the standards for registering medical devices under international harmonization standards on classification and assessment with implementation set to start July 1. The...

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