The document outlines the key points related to the applicable classification requirements for specific types of medical devices.
Table Of Contents
The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the classification of rehabilitation, physiotherapy, and speech therapy devices. The document provides additional clarifications regarding the regulatory requirements set forth under the existing framework, as well as recommendations to be followed by the parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. Furthermore, in case of any discrepancies with the provisions of the applicable regulations, the latter should prevail.
Regulatory Background
First of all, the authority outlines the legal framework the document is based on. According to the guidance, the applicable regulatory requirements are set forth by the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. The authority additionally emphasizes its right to request additional information, beyond the scope prescribed by the aforementioned regulations, should such additional information be reasonably necessary for the authority to assess the safety and effectiveness of a medical device subject to review.
The Medical Device Act 2012 provides the definition of a medical device. The said definition is used to determine the legal nature of a product in question and the legal framework to be applied with respect to it. In particular, this definition differentiates medical devices and not medical devices based on a clear indication of the mode of action for the product being used for rehabilitation, physiotherapy, and speech therapy. The authority additionally emphasizes that medical device manufacturers are responsible for demonstrating the safety and proper performance of a medical device when used for its intended purpose based on the applicable criteria.
The present guidance describes the approach to be applied by medical device manufacturers and their authorized representatives when determining the classification of rehabilitation, physiotherapy, and speech therapy products. In particular, the document outlines the rules to be followed when determining whether the product in question is subject to regulation under the medical devices framework or not.
Terms and Definitions
In order to assist medical device manufacturers and other parties involved in the proper interpretation of the respective regulatory requirements, the guidance provides definitions of the most important terms and concepts used in the context of devices covered by its scope. In particular, the document defines the following terms:
- 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 or normal functions of everyday activities and day to day life.
- Rehabilitation – a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with 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 – services to individuals and populations to develop, maintain and restore maximum movement and functional ability through the lifespan, including in circumstances where movement and function are threatened by aging, injury, pain, disease, disorders, conditions, or environmental factors.
Apart from the above, the guidance provides definition of the intended use/purpose, and also refers to the definitions of the manufacturer and medical device provided in the Act 737.
Classification: General Principles
According to the guidance, some of the products for rehabilitation, physiotherapy, or speech therapy are falling within the scope of medical device definition and, consequently, are subject to regulation under the medical devices framework, while others don’t. Thus, it is vitally important to determine properly the applicable regulatory framework.
The present guidance contains an annex that outlines the products for rehabilitation, physiotherapy, or speech therapy to be regulated as medical devices. All the products listed therein are divided into categories, and the appropriate description is provided.
In particular, the categories of products described in the guidance include the following ones:
- Ambulation training;
- Band/tube;
- Boards/pads;
- Cognitive/vestibular/sensory/motor therapy;
- Mats;
- Measurement;
- Miscellaneous;
- Pediatric tools;
- Speech therapy;
- Treadmill/body trainer/bike/elliptical;
- Upper range-of-motion (ROM) exerciser (finger/wrist/hand/shoulder);
- Wedges/rolls/balls/disc;
- Weight.
The scope of products to be regulated as medical devices includes, for example, a body trainer – a device intended to restore some or all of the patient’s physical, sensory, and mental capabilities that were lost due to injury, illness, or disease; total body ergometer is a treatment or treatments designed to facilitate the process of recovery from injury, illness or disease to as normal a condition as possible.
In summary, the present MDA guidance describes the approach to be applied when determining the regulatory status of rehabilitation, physiotherapy, and speech therapy products. The document outlines the general principles and also provides a list of products falling within the scope of the medical devices framework.
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