Malaysia: Code of Advertisement Medical Device Regulations
The Code of Advertisement is a Guidance Document (MDA/GD/0032) issued by the Malaysian Medical Device Authority (MDA) to ensure good marketing practices and advertising messages that are socially responsible and ethical. It forms part of the Medical Device (Advertising) Regulations 2019 in Malaysia that were fully implemented on 4 May 2021.
Please note that the Code of Advertisement was originally published as Section 5 of MD/GD/0032 in October 2020. The second edition of MD/GD/0032, published in March 2021, is dedicated exclusively to the Code of Advertisement (COA).
What is considered a medical device advertisement in Malaysia?
The MDA states that a medical device advertisement is any statement, pictorial representation, or design, which directly or indirectly intends or claims to promote the use or supply of anything related to the medical device.
Advertisements include announcements of a public nature and conveyed by or through any signage, image or sound disseminated through any medium for advertising purposes.
Who can advertise a medical device in Malaysia?
The responsible “person” for the medical device advertisement shall be the manufacturer or authorized representative of the medical device who may assign advertisers (including private individuals or any third party) to advertise the medical device on their behalf.
A person who advertises a medical device must have authorization from the manufacturer or authorized representative.
Advertisement specifications
The Code of Advertisement (COA) states that advert shall present information which is factually correct and not exaggerated. Promotional materials shall be accurate, objective and of high ethical standards.
Advertisements should encourage the correct and proper use of a medical device and not mislead such as falsely describing the medical device, its nature or quality, its use or effects.
Claims made shall not be stronger than scientific evidence warrants, and every effort should be made to avoid ambiguity.
The COA stipulates requirements with regard to:
- various medical device claims such as therapeutic claims, device novelty claims and safety claims
- the content of the advert such as the use of superlatives or comparatives, endorsements, standards of decency
- whether the advertisement is aimed at specific groups of people such as children, disabled people or senior citizens.
- please refer to the guidance document for the full list.
The guidance document lists various types of advertising materials covered by the COA including but not limited to:
- all forms of internet advertising such as websites, pay-per-click advertising and social media
- marketing information such as point-of-sale materials, talk shows, directories
- posters/flyers including calendars
- sponsorship
- tv and radio including video recordings
- please refer to the guidance document for the full list.
How to obtain advertising approval in Malaysia
The Malaysian Medical Device Authority (MDA) has published a guide listing the requirements for applying to obtain approval for medical device advertisements from the MDA entitled “Application for medical device advertisements approval – requirements” (MDA/GL/04). This document provides an overview of the application procedure for medical device manufacturers, distributors and healthcare professionals who intend to advertise their medical devices. Read about the guide here.
How Andaman Medical can help
If you need advice or assistance on registering or advertising your medical device in Malaysia, please contact our sales team at sales@andamanmed.com
Find out more about the Malaysian medical device market here.
Click on the following links for what you need to know about medical device registration, local authorized representation, importation and distribution in Malaysia.