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Asia: MDA Malaysia issues first-edition document on classification of devices

2022/06/14  MDA Malaysia

Introduction
The definition of medical device is legally binding in the Medical Device Act 2012 (Act 737) and it determines the scope of regulatory control of the product. This definition differentiates medical devices and not medical device based on clear indication on mode of action for the product been used for rehabilitation, physiotherapy and speech therapy. 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 document is intended to provide guidance to manufacturers and authorised representatives on the classification of rehabilitation, physiotherapy and speech therapy products.

Scope
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

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