Malaysia MDA Announcement: Placement in the Market and the Use of Non-registered Device without Clin
On 24 Apr, Malaysia MDA made an announcement regarding the placement in the market and use of non-registered device without clinical proof. The announcement is as stated below:
The Medical Devices Authority (PBPP) has always looked upon issues related to the safety and efficacy of medical devices in the market. Lately, there are many advertisements in mass media and social media regarding service offerings using unregistered electrostatic and electromagnetic devices such as ozone therapy machines, Al-Jabbar therapies, sonotrons and others.
Based on the claims made, these devices may be categorized as medical devices according to the interpretation set forth in Section 2 of the Medical Devices Act 2012 (Act 737). Accordingly, Section 5 of Act 737 applies to these devices and is required to be registered under this Act. Through this registration process, PBPP will evaluate the safety and effectiveness of these devices. However, until now PBPP has not received any registration application for the above devices. As such, the effectiveness and security of such devices cannot be verified.
PBPP advises the public not to believe and be affected by advertisements containing claims made on those devices. PBPP also recommends that the public not get services that use these devices to prevent the public from being exposed to risks that may result in accidents and harm to health.
Companies are also urged to apply for medical device registrations and to stop placement in the market as well as to offer service using the medical device. If the company fails to comply with this directive, the company may be liable to a fine not exceeding two hundred thousand ringgit (RM 200 000) or to imprisonment for a term not exceeding three years or both as provided under Section 5 (2) of the Medical Devices Act 2012 (Act 737).
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