Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements  

This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required. 

The following materials are controlled through self-regulation, and shall comply with the requirements of this guidance document and do not require approval: 

a) All medical device advertisements aimed at:

  1. Personnel that are directly involved in procurement, or administration in a healthcare facility; and
  2. Healthcare professionals

These advertisements shall not be advertised to the general public. 

b) materials that only contain product pictorial representation, brand and/or company name and/or logo that do not consist of any product claims or descriptions including catalogs, brochures, flyers, and etc.

c) materials which only contain exact replica of the packaging (not size but shape and content) as approved by the Authority during medical device registration.

d) Advertorial, disease awareness and health education campaigns, contests and competitions, sponsorship. 

Only medical devices registered with the Authority may be advertised. There shall be no misleading or fraudulent claims in respect of the medical device in any advertisement. 

All advertisement shall comply with guidance document of Code of Advertisement (COA)-MDA/GD/0032. 

An application for approval to the authority shall be made for all advertisement of medical devices relating to: 

  1. home use medical devices; and
  2. advertisement aimed for the general public.

If the Authority is satisfied with the advertisement application, the authority will issue an approval number for the particular advertisement. 

More details: MDA/GL/04 Application For Medical Device Advertisement Approval – Requirements 

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