ADVERTISEMENT OF MEDICAL DEVICE

What is the definition of advertisement in the Evidence Act 1950 [Act 56]?

Any statement, pictorial representation, or design, by means of any document as defined under the Evidence Act 1950 [Act 56] or by any other means, which is intended or claimed, whether directly or indirectly, to promote the use or supply of anything related to medical devices. Advertisement includes an announcement of a public nature, whether for the sale or purchase of a medical device or constituting an invitation to participate in an activity, and is conveyed by or through any signage, image, or sound disseminated through any medium for advertising purposes.

Conclusion: Advertisement refers to any statement, pictorial representation, or design intended to promote the use or supply of medical devices, whether directly or indirectly, through any medium, including signage, images, or sound.

How to Submit a Medical Device Advertisement Application?

To submit an advertisement application for medical devices, please refer to the following guidelines and resources that clarify the requirements for advertisements that require or do not require approval:

Reference Documents:

Guidance Documents MDA/GD/0032: Code of Advertisement – Outlines the standards and principles for advertising medical devices.
Guidelines: Application for Medical Device Advertisement Approval - Requirements – Details the approval process and necessary documentation.

Application Forms & Templates:

Advertisement Application Online Form – Digital submission platform for advertisement approval.
Advertisement Application Form – Printable version for manual submission.
Attestation & Declaration Form – A required form to certify the accuracy and compliance of the advertisement application.
Template for an Advertisement Letter of Authorisation – Standard template for authorisation letters related to advertisement applications.

The process flow for an advertisement application is as follows:

*working days

IMPORTANCE NOTICE:

1. Applicants are required to complete all requested information on the form to confirm that all necessary documents have been submitted.

2. Please ensure your application is submitted via the designated Google Form, as incomplete applications will be rejected.

3. Please note that from 1^st March 2025, any application received via email will not be processed and will need to be re-applied using the online form.

4. This situation is subject to any terms and conditions that may apply. For any inquiries or further information, please contact:

Email to advertisement@mda.gov.my
Officer in-charge;
- Nur Syafura Ariffin (+603-82300 352)
- Suhaida Rasul (+603-82300 214)
- Haidar Nadhirah Binti Hawalig (+603 82300 250)
- Nur Maizura BInti Zarmani (03-82300 339)
- Hasdiana Binti Mohammadiah (03-82300 364)

Updated: 19th March 2025

By: Corporate Communication Unit