The Malaysian Medical Device Authority (MDA) has published the first edition of a guidance document on the classification of products involved in rehabilitation, physiotherapy, and speech therapy in April 2022.
The document provides some insights on how to determine whether these products can be categorised as medical devices or non-medical devices.
MDA has provided a list of products that are classified as medical devices in Annex A and some of the examples include parallel bars, that are used for patients undergoing physical therapy, professional exercise mats, examination lamp, and hand exercise balls.
More details can be found in “MDA/GD/0061 Classification of Rehabilitation, Physiotherapy, and Speech Therapy Device, 1st edition, April 2022”: https://portal.mda.gov.my/documents/draft-guidance-documents/1971-mda-gd0061-rehabilitation,-physiotherapy-and-speech-therapy/file.html