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Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline

Regulatory Updates | Medical Devices

Malaysian Regulator Push Back Medical Device Labeling Requirements Emergo

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA is extending medical device labeling compliance deadlines by three years.
  • The extended transition period is intended to allow Malaysian market registrants enough time to ensure compliance.

Malaysia MDA delays medical device labeling rule to 2021The Malaysian Medical Device Authority (MDA) is adding a three-year transition period for compliance to new medical device labeling rules.

According to an MDA circular letter, the regulator had originally set a two-year transition period starting  in 2016; that deadline is now extended to 2021.

“The transition period will assist industry to comply with the labeling requirements in accordance with the Six Schedule of Medical Device Regulation 2012 and to implement the labeling of the medical device before the compliance of the labeling requirements is enforced,” MDA states in the letter.

In the meantime, Malaysian medical device market registrants should follow existing labeling requirements.

Related Malaysian medical device regulatory resources:

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