Malaysia MDA releases draft guidance on the classification of rehabilitation, physiotherapy and speech therapy devices
Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices. Industry stakeholders are invited to comment on the draft guidelines until 2 March 2022.
The guidance states that the classification as a medical device will be made upon the clear indication of the mode of action for rehabilitation, physiotherapy or speech therapy. The draft guidance document gives clear differences as to when a product is classed as a medical device and when it is not.
For a rehabilitation, physiotherapy or speech therapy product to be classed as a medical device, the instrument, apparatus, implement, machine, appliance, material or other similar or related article must be intended by the manufacturer to be used, alone or in combination, for the purpose of:
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
- the investigation, replacement or modification, or support of the anatomy or of a physiological process.
The above criteria also apply to software. However, a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment may not be considered as a medical device.
The guidance document lists examples of the classification of different categories of rehabilitation, physiotherapy or speech therapy products:
- Ambulation Training
- Anatomical Chart/Models
- Exercise Band and Tubing and Straps
- Bedding / Pillow
- Cognitive / Vestibular / Sensory / Motor Therapy
- Pediatric Tools
- Rehabilitation Software
- Speech Therapy
- Stretching Aids
- Treadmill / Body Trainer / Bike / Elliptical
- Upper Range-of-Motion (ROM) Exerciser (Finger / Wrist / Hand / Shoulder)
- Wedges / Rolls / Balls / Disc
How to submit comments
Industry stakeholders can submit their comments using the BK_BDKS_054 Feedback form Rehabilitation Physiotherapy Speech Therapy which is to be sent to firstname.lastname@example.org before 2 March 2022.
For more information
If you have any queries regarding the classification of rehabilitation, physiotherapy or speech therapy devices, please contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.