Malaysia: Medical Device Advertisement Approval Requirements

ARQon
Jul 8, 2021
2 min read

The Medical Device Authority (MDA) in Malaysia has established a new Guideline to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guideline shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations 2012; and

c) Medical Device (Advertising) Regulations 2019.

This Guideline on Advertisement of Medical Devices is intended:

To provide guidance in ensuring good marketing practices and advertising messages which promote the quality use of medical device in a socially responsible and ethical manner.
Explains who is the person responsible to comply with the requirement and information required in advertisements. All advertisement shall comply with guidance document of Code of Advertisement (COA)-MDA/GD/0032.

Application Process

An application for medical device advertisement approval shall be made for home use medical devices advertisement and advertisement aimed for the public.

Application shall be submitted by using ‘Application Form for Medical Device Advertisement’ to the Authority via email or post/courier. The application form can be downloaded from MDA website at www.mda.gov.my. This Guideline also includes the conditions for applications to facilitate the advertiser during application.

Upon approval by the authority, the advertiser is responsible to ensure the advertisement to be posted, displayed or broadcasted is the same as that approved by the Authority.

Changes in the advertisement

Any change in the content of advertisements or any new issuance of the same advertisement using other languages requires for a new application for approval except for editorial changes and pictorial changes that delivers a same message or claim.

Source: Advertisement Guideline