This guidance document describes how to classify products used in rehabilitation, physiotherapy, and speech therapy. A product is classified based on its intended use as well as on whether it is a medical or non-medical device. The guidance also lists a number of products used in the rehabilitation, physiotherapy, and speech therapy, which are classified as a medical devices.
The following are the definitions which are listed in the guidance:
- 1. 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.
2. 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. This also includes physical or mental conditions that disturb the regular or normal functions of everyday activities and day to day life. They can take up a lot of time and complicate the normal functioning of an individual.
- 3. Rehabilitation
A set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment.
- 4. Therapy
Restoring and compensating for the loss of functioning, and preventing or slowing deterioration in functioning in every area of a person’s life.
- 5. Physiotherapy
Physiotherapy (sometimes referred to as physical therapy) services individuals and populations to develop, maintain and restore maximum movement and functional ability throughout the respective lifespan, including in circumstances where movement and function are threatened by ageing, injury, pain, disease, disorders, conditions or environmental factors. Functional movement is central to being healthy.
All manufacturers and authorised representatives must ensure registration approval from MDA before marketing these rehabilitation, physiotherapy, and speech therapy devices in the market.
References:
Classification of Rehabilitation, Physiotherapy and Speech Therapy Device