ADVERTISEMENT OF MEDICAL DEVICE

 

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 can I submit an advertisement application for medical devices?

All information, guidelines, and guidance documents that clarify the requirements for advertising medical devices that require approval or do not require approval can be referred to;

Ø    Guidance Documents MDA/GD/0032: Code of Advertisement

Ø    Guidelines: Application for Medical Device Advertisement Approval - Requirements

Ø    Advertisement Application Form

 

The process flow for an advertisement application is as follows:

 

 

 

Submission and Payment Instructions for Medical Device Advertising

 

 IMPORTANCE NOTICE:

Applicants are required to complete all requested information on the form and to fill out the Checklist form to confirm that all necessary documents have been provided. Please submit your application via email to advertisement@mda.gov.my, as incomplete applications will be rejected

 Please note that starting from 1st December 2023, all advertisement submissions must be sent via email to advertisement@mda.gov.my. Any applications received in hardcopy after this date will not be processed.

For any inquiries and further information;

v  Email to advertisement@mda.gov.my

v  Officer in-charge;

(1)  Nur Syafura       +603-8230 0352

(2)  Suhaida Rasul   +603-8230 0214

 Updated: 8 November 2024