New Guidance Was Issued For Rehabilitation, Physiotherapy, And Speech Therapy Devices
First edition guidance on the classification of rehabilitation, physiotherapy, and speech therapy devices was issued by the Ministry of Health Malaysia on 22 April 2022.
The Medical Device Authority (MDA) published the guidance document to outline the terms and definitions of rehabilitation, physiotherapy, and speech therapy. This provides manufacturers and authorized representatives a guide to how medical devices are classified
This document provides guidance on how to classify products that are used for rehabilitation, physiotherapy, and speech therapy. The classification of a product is based on what the product is supposed to do or what the manufacturer says it does, and whether it is a medical or non-medical device.
According to MDA/GD/0061, the following terms and definitions related to disability, disorder, rehabilitation, therapy, and physiotherapy are listed below:
Disability– An umbrella term for impairments, limitations of activity, and restrictions on participation resulting from the interaction between people with health conditions and the environmental barriers they encounter.
Disorder– An illness that disrupts normal physical or mental functions.
A set of problems, which result in causing significant difficulty, distress, impairment, and/or suffering in a person’s daily life. Physical or mental conditions that disturb the regular functions of everyday activities. They can take up a lot of time and complicate the normal functioning of an individual.
Rehabilitation– A set of interventions that are designed to help people with health conditions function better in their environment.
Therapy– Restoring and compensating for the loss of functioning, and preventing or slowing deterioration in functioning in every area of a person’s life.
Physiotherapy/physical therapy– Services to individuals and populations to develop, maintain and restore maximum movement and functional ability throughout the lifespan.
All manufacturers or authorised representatives must obtain registration approval from MDA in Malaysia prior to marketing these rehabilitation, physiotherapy, and speech therapy devices. By having the classification of a list of products used for rehabilitation, physiotherapy and speech therapy in Annex A, manufacturers or authorised representative can differentiate whether they are medical devices or non-medical devices based on their description or intended purpose or indication as claimed by the manufacturer. This can reduce wrong product classification, and save cost and time for registration approval.
For more information:
Click here https://www.mda.gov.my/documents/draft-guidance-documents/1971-mda-gd0061-rehabilitation,-physiotherapy-and-speech-therapy/file.html for the full guidance on classification of rehabilitation, physiotherapy and speech therapy device by the MDA. If you have any questions regarding medical device registration and representation in Malaysia, please contact us at [email protected]