Malaysia Issues Draft Medical Device Advertising Law

Medical Device Authority

MedicalDeviceAuthority ( – The Medical Device Authority of Malaysia (MDA) has issued a draft of the “Code of Advertisement for Medical Devices” to provide guidance “in ensuring good marketing practices and advertising messages which promote the quality use of medical devices in a socially responsible and ethical manner.”

According to the Guidance Document, only registered devices can be advertised and all claims surrounding the medical device must be accurate and unambiguous. 

In addition, medical device advertisements are self-regulated, therefore the “responsible person” for medical device advertisements must be the authorized representative of the medical device or an official third party representative.
Manufacturers advertising medical devices in Malaysia should be aware of the various requirements regarding advertisement claims. Important provisions in the current draft law include:

• Advertisements must not promote devices for unapproved patient groups.
• Advertising claims should be based only on scientific evidence and avoid ambiguous statements.
• Advertisements should not attack or discredit other medical devices or companies.
• Advertisements should avoid using “fear and superstition” to promote devices.
• All advertisements, regardless of medium, must include the full manufacturer’s name and contact number, establishment license number, name of medical device, and the medical device registration number.

In February 2016, the Malaysia Medical Device Authority (MDA) released a set of guidelines that will help medical device manufacturers comply with Malaysia’s regulations. The guidelines will support manufacturers as they complete the Declaration of Conformity, a legal document drawn up by manufacturers assuring that the device complies with all applicable laws.

The guidelines provide detailed definitions of key words found in the Declaration of Conformity. The guidelines also emphasize that the Declaration of Conformity must be signed by top management.


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