a reminder that medical devices must be registered and imported correctly

A Reminder That Medical Devices Must be Registered and Imported Correctly

Malaysia’s Medical Device Authority (MDA) issued a reminder on 5 April 2022 that imported medical devices must be registered and imported by a licensed establishment as provided in sections 5 (1) and 15 (1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA.

If you are involved in importing medical devices, you need to provide documents like your license certificate, registration certificate, letter of approval, notification letter, letter of authorization, or other relevant documents. This will help avoid any disruptions to the importation process.

One of the ways that the country tries to stop people from importing medical devices without a license is by screening and inspecting them at the main entry points. As the full announcement states, failure to comply with the law can result in fines or imprisonment.

Please contact us at sales@andamanmed.com if you have any questions about these announcement or our services for medical device registration and representation in Malaysia.

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