Malaysia Issues Draft Medical Device Advertising Law

In March 2016, the Medical Device Authority of Malaysia (MDA) 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.