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Medical device labeling requirements in Malaysia are outlined in the Medical Device Authority‘s (MDA) 2018 Guidance Document. The MDA issued the Fifth Edition for comment in April 2022. While many of the requirements remain the same, one new provision is that the MDA is allowing and encouraging manufacturers to use a QR code for the registration number.
The general labeling requirements are as follows: the medium, format, content, readability and location of the label should be appropriate for the device and should contain as much information as possible for the user to be able to identify and safely use the product. When Instructions For Use (IFU) is included, it should be written using clear language. Note that low and moderate risk medical devices do not require IFUs. Paper versions of all labelling must accompany the product.
All products should be labeled in English. Products intended for home use should be labeled in both English and Bahasa Malaysia.
The label cannot claim promotion or endorsement by the Ministry of Health or Medical Device Authority or any related organizational bodies.
Beginning August 2021, the following additional labeling information will be required:
Some devices require additional labeling contents, including:
Circular letter No 1, Year 2017 Rev 1 states that Medical Devices intended for export only are exempted for labeling requirements, given:
IVD products must adhere to additional requirements on top of the above outlined Medical Device guidelines.
IVD products will also need to include:
Contact Asia Actual to see if our Malaysia labeling solutions are right for your needs.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Malaysia@asiaactual.com
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