Medical device advertising approval in Malaysia
The Malaysian Medical Device Authority (MDA) has recently published the first edition of 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.
The guide’s main objective is to ensure the promotion of advertisements that practice good marketing and do not promote any misleading or fraudulent claims in respect of a medical device. Moreover, only medical devices registered with the Authority may advertise. All promotional materials must adhere to the regulations defined in Section 44 of the Medical Device Act 2012 and the Medical Device (Advertising) Regulations 2019.
According to the new guide, medical devices that require advertisement approval are those medical devices that are registered with the MDA for the general public or home use (as per the definition of medical devices as outlined in Section 2 of Act 737). A home-use medical device is labeled for use in any environment outside a professional healthcare facility and is intended for use by healthcare professionals and/or laypersons.
The advertiser must submit all applications to the Authority by using the ‘Application Form for Medical Device Advertisement’ in Annex A of MDA/GL/04, by email to email@example.com or hard copies via post/courier. The application should contain:
- A completed application form
- Copy of the proposed advertisement for the registered medical device
- RM1000 Bank Draft payable to ‘KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN’
- Appointment/Authorization Letter from the manufacturer or Authorized Representative
- Copy of translated advertisement (if the ad is in another language other than Bahasa Malaysia and English)
- Supporting documents (where applicable) such as:
- Testimonial consent letter from the users of the medical device to be advertised
- Celebrity Endorsement Consent letter from the celebrity
- Test, trials, or scientific reference approval or permission letter from the sponsor/investigator (hospital) and data/reports/evidence of claims.
For all successful advertisement applications in Malaysia, the MDA will issue a medical device advertisement approval number that must be included in the advert. Advertisement approvals will become invalid when:
- The medical device reaches its expiry date
- There are changes to the claims of the medical device as per registration information.
It is important to note that a new application for medical device advertisement approval is required when there are:
- Changes in the content of advertisements
- New issuance of the same advertisement using other languages
- Pictorial change that presents a new message or different claim.
Read the full guide on applying for approval of medical device advertisements in Malaysia from the MDA, click here.
If you have any queries regarding advertising medical devices or our services for medical device registration and representation in Malaysia, please contact us at firstname.lastname@example.org