Malaysia: New Guidance on Labelling Requirements for Medical Devices

The Medical Device Authority (MDA) has prepared a guidance document on labelling requirements for medical devices under the Medical Device Act (Act 737) and its regulations.

The guidance document explains, among others, what information a label should contain, what kind of format is allowed and the location of labelling.

According to the new guidance medical devices registered in Malaysia shall be labelled with a Malaysian medical device registration number and this shall be carried out within 6 months from the date of registration of the medical device. The contents of a label must be submitted to the Medical Device Authority during the device’s registration. Devices intended for use at home should be labeled in English and in Bahasa Malaysia. All other devices must be labeled in English only, the guidance says, adding that other languages may be used as necessary.

For the guidance please click here: MDA-Malaysian Labelling Guidance.


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