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Malaysia To Phase In Medical Device Registration Process To Avoid Backlash

 
• By Ed Lane

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...

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