Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to classify rehabilitation, physiotherapy, and speech therapy products.
It is the responsibility of the manufacturer to demonstrate that its product is safe and perform as its intended use/ purpose based on essential safety and performance criteria for the medical device.
This guidance will aid manufacturers and authorised representatives on the classification of rehabilitation, physiotherapy and speech therapy products.
This guidance document provides the classification of a list of products used for rehabilitation, physiotherapy and speech therapy by determining whether they are medical devices or non medical devices based on their intended purpose as claimed by the manufacturer.
As part of the draft list, MDA included both products that are medical devices and those that are not, as well as a column that categorized the products as medical devices.
Click this LINK to know more about this guideline.
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