Malaysia’s Ministry of Health Medical Device Authority (MDA) division recently updated its "Guidelines on Classification of Rehabilitation, Physiotherapy & Speech Therapy Devices".
It is important to note that the MDA has established a classification system for medical devices, including rehabilitation, physiotherapy, and speech therapy devices. This classification system helps ensure that these devices are properly regulated based on their level of risk to patients.
A rehabilitation device is a device that assists patients in recovering from injury or illness and can range from simple aids like crutches to more complex devices like prosthetics and robotic exoskeletons.
Physiotherapy devices are designed to assist in the rehabilitation of patients through physical therapy exercises and treatments. They can range from simple devices like resistance bands and foam rollers to more complex ones like electrotherapy machines and ultrasound machines.
The purpose of speech therapy devices is to assist patients in overcoming speech and language disorders. Devices range from simple aids such as communication boards and speech amplifiers to more complex devices such as voice recognition software and electroglottographs.
The MDA's regulatory requirements must be met by manufacturers of these devices in order to ensure patient safety and effectiveness. Click this LINK to know more about this guidance.