Home About Qualtech NEWS MALAYSIA: Placement and Use Of Unregistered Medical Devices, With No Clinical Evidence, In The Market – May, 2019
MALAYSIA: Placement and Use Of Unregistered Medical Devices, With No Clinical Evidence, In The Market – May, 2019

May 13, 2019

MDA has reminded all stakeholders that it is unlawful to market unregistered medical devices with no clinical evidence in Malaysia. In a latest announcement, MDA advises the general public not to believe and be affected by advertisements which contain claims made on this type of devices. Please see the official Announcement, translated into English by Qualtech, as below:

______________________________________________________________________________

ANNOUNCEMENT

PLACEMENT AND USE OF UNREGISTERED MEDICAL DEVICES, WITH NO CLINICAL EVIDENCE, IN THE MARKET

The Medical Devices Authority (MDA) has always been concerned about the issues pertaining to the safety and efficacy of medical devices in the market. Lately, there have been many advertisements mass media and social media related to service offers using unregistered electrostatic and electromagnetic devices, such as ozone therapy machine, Al-Jabbar therapy machine, sonotron therapy machine and others.

Based on the claims made, these devices can be categorized as medical devices, according to the definition set out in Section 2 of the Medical Devices Act 2012 (Act 737). Accordingly, Section 5 of Act 737 applies to these devices and they must be registered under this Act. Through this registration process, MDA will make an assessment to determine the safety and effectiveness of these devices. However, until now MDA has not received any application for registration for the devices mentioned above. As such, the effectiveness and security of such medical devices cannot be verified.

MDA advises the general public not to believe and be affected by advertisements which contain claims made on those devices. MDA too suggests that the general public not to use the service provided by these devices to prevent the public from being exposed to possible risks, resulting in accidents and harm to health.

Companies are also urged to apply for medical device registrations and terminate market placements, including service offerings using these devices. If any company is found not to comply with this directive, the company would 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 may be provided for under Section 5 (2), Medical Devices Act 2012 (Act 737).

Medical Devices Authority

Ministry of Health Malaysia

Date: April 24, 2019

Translated from official MDA notice, by:

Qualtek New Logo

References:

Pengumuman: Peletakan Dalam Pasaran Dan Penggunaan Peranti Yang Tidak Berdaftar Dan Tidak Mempunyai Bukti Klinikal


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Home About Qualtech NEWS MALAYSIA: Placement and Use Of Unregistered Medical Devices, With No Clinical Evidence, In The Market – May, 2019