Enforcement Announcement by Malaysian Medical Device Authority (MDA) Following an Investigation into the Use of Unregistered Medical Devices
Any individual, company or health facility involved in providing medical services must apply for the Medical Device Registration and Establishment License, as defined in Sections 5 and 15 of the Medical Devices Act 2012 (Act 737).
An investigation and subsequent results of the compliance monitoring activities conducted by the MDA, found individuals and health facilities importing unregistered medical devices and offering health services such as treatment, therapy, diagnosis using these devices. The aforementioned activities are regulated under Act 737, and these activities are only allowed to be conducted only once the medical devices are registered with the MDA.
Therefore, individuals, companies, or health facilities that are not complying under the Act 737, are required immediately to apply for medical device registration and establishment licenses. They are also required to cease placement of the unregistered medical devices in the market.
Individuals, companies, or health facilities found guilty of violating this rule may be fined not exceeding two hundred thousand ringgit (RM 200, 000), or imprisonment for a term not exceeding three (3) years, or both as stipulated under Section 5 (2 ), Act 737.
MDA constantly monitors the import and placement activities of medical devices in the local market from time to time with compliance to Act 737. Any person with knowledge of the import and placement activities in the market of unregistered medical devices or the use of unregistered medical devices in health facilities can report the information to MDA through the online complaints and inquiries system or contact MDA via 03-82300300 or email: firstname.lastname@example.org.
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