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Malaysia Consults On Medical Device Risk Classifications

 
• By Ashley Yeo

A 20-day consultation on the risk classification of medical devices intended for the Malaysia market ends on 28 February.

Small Flag of Malaysia Sticked in the Map Background with Selective Focus.

Public comment on a new Malaysian guidance document on medical device risk classification is being sought by the Medical Device Authority (MDA). The authority is inviting feedback by 28 February on the updated guidance, which is intended to help the devices industry and health care professionals to comply with Medical Device Act (Act 737) of 2012.

The 36-page document, MDA/GD/0009, applies to devices (defined in guidance MDA/GD/0006) but not to in vitro diagnostics, which are covered by guidance document MDA/GD/0054.

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