As of July 1, 2018, all Medical Devices must meet the registration requirements set forth in section 5 of the Medical Device Act 2012 in order to be marketed in Malaysia.






Published on May 21, 2018 and available only in Malay language, the Malaysian Regulatory Authority Notification confirms that as of July 1, 2018 no medical device shall be imported, exported or placed on the market without a regular registration issued by the MDA.

All registration applications submitted to the MDA before June 30, 2016 shall be completed by June 30, 2018.

Furthermore, the Acknowledgment Letters used by companies to market devices in Malaysia will no longer be valid and manufacturers shall prepare and submit registration applications in time to legally keep on marketing in the country.

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