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:
- 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.
- 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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