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Malaysia Extends Device Labeling Deadline by Three Years

August 21, 2018

Malaysia’s Medical Device Authority is pushing back device labeling requirements to allow for a three-year transition period to give devicemakers more time to meet the new requirements.

Previously, a two-year transition period was to apply beginning in 2016. Manufacturers will now have until 2021 to meet the new labeling requirements, which were to be in effect beginning in 2018.

The agency said that existing labeling will apply during the transition period. The new labeling requirements coincide with new device registration requirements for importing, exporting, or placing medical devices on the market.

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