Malaysia: Draft Regulation on ‘Wearable Medical Device’ for Public Comments

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows:

  1. Scope: To determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device Act 2012 (Act 737). This guidance document is applicable to the establishments that are dealing with wearable medical devices.
  2. Exclusion: This guidance document excludes the products that are intended for general wellness and do not have medical claims.
  3. Coverage: Determination of wearable medical devices, regulatory requirements for wearable medical devices, and examples of wearable products classified as medical devices and non-medical devices.
  4. Submission of Public Comment: Due date is 08 September 2023. Feedback can be submitted to using this form.

This announcement can be accessed here.

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