Introduction
This guidance document describes how to classify products used in rehabilitation, physiotherapy, and speech therapy. The classification is based on the product's intended use and whether it is a medical or non-medical device. Additionally, a variety of products used in these fields are classified as medical devices.
Definitions
The following definitions are provided in the guidance:
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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. This includes a set of problems that cause significant difficulty, distress, impairment, or suffering in a person's daily life. Disorders can consume considerable time and complicate the normal functioning of an individual. -
Rehabilitation
A set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment. -
Therapy
The process of restoring and compensating for the loss of functioning, as well as preventing or slowing deterioration in functioning. -
Physiotherapy
Physiotherapy (often referred to as physical therapy) services individuals and populations to develop, maintain, and restore maximum movement and functional ability throughout their lifespan. This applies in circumstances where movement and function are threatened by aging, injury, pain, disease, disorders, conditions, or environmental factors. Functional movement is central to being healthy.
All manufacturers and authorized representatives must ensure registration approval from the MDA before marketing rehabilitation, physiotherapy, and speech therapy devices.
Additional Information
For further details, refer to the MDA Guidance Document - https://portal.mda.gov.my/documents/draft-guidance-documents/1971-mda-gd0061-rehabilitation,-physiotherapy-and-speech-therapy/file.html.