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Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device

On March 9 2023, the MDA has announced the release of the Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061). This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and speech therapy by determining whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer.

The key point of this Second Edition Guidance Document are as follows:

  1. Weight such as Wrist and Ankle weights, Adjustable Cuff Weight were added in Annex A: List of products for rehabilitation, physiotherapy or speech therapy that are classified as medical device.
  2. The sample of Medical Devices for Rehabilitation, Physiotherapy and Speech Therapy with description and picture can be found in Annex B of the guidance document.

Further information on Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061), please refer to this link.

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