MALAYSIA: MDA Announced the Second Edition on Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices – April/May 2023

• 2023-04-25 01:40:47

The MDA published the Second Edition Guidance Document, “Classification Of Rehabilitation, Physiotherapy And Speech Therapy Device” (MDA/GD/0061), on March 08, 2023. This document is directed to give manufacturers and authorized representatives (AR) an appropriate guideline on the classification of rehabilitation, physiotherapy, and speech therapy products. This guidance document classifies a number of products used for rehabilitation, physiotherapy, and speech therapy as medical devices or non-medical devices respectively, based on the manufacturer's stated intended purpose.

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MALAYSIA: MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

• 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

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