Only medical devices registered with the MDA may be advertised. However, the establishment shall be no misleading or fraudulent claims in the advertisements. There are two responsible persons for the advertisement which is the manufacturer or authorized representative (AR). Also, the manufacturer or AR may assign and authorize the third party which can be a private individual or any third party to advertise the medical device on their behalf and ensure to comply with the regulatory requirements.

The application shall be submitted using the form provided in Annex A of the guidelines, “Application Form for Medical Device Advertisement” and need to send via email to [email protected] or hard copies to MDA. A copy of the advertisement and script shall be submitted together with the form. Any recording video shall be submitted in the appropriate media such as the thumb drive or flash drive. However, the advertisement that consists of sound video or recording to be advertised on TV, radio, and internet shall be made in a separate application. However, if the content has the same script can be filed in one application. The advertisement with the same content other than recording for the multiples devices within one advertisement may be submitted in one application. Below id the examples scenario:

Advertisement type

One application

Separate application

One media, same content

ü

One media, different content

ü

Different media, same content (without sound/video)

ü

Different media, same content (with sound/video)

ü

Different media, with the same content of sound/video)

ü

Multiple products within one advertisement

ü

Different language with the same content

ü

The languages besides Bahasa Malaysia and English shall be provided with the translation version during the applications. MDA also stated the translated version must be endorsed by a body recognized by the MDA such as the Malaysian Institute of Translation and Books (ITBM), etc.

The processing fee for each application is RM 1,000.00 and non-refundable. At the moment, all payments shall be paid through band draft. The authority will review the application after receiving the payment. If satisfied, they will issue an approval number and the establishment needs to ensure advertise the submitted content of advertisement only. Upon the expiry of product registration of the medical device, the advertisement will be invalid. Post-approval of the content of an advertisement, if there is any change in the content such as the claim of the medical device are requiring for a new application. However, if the changes are related to pictorial changes that still use the same claim are not require a new application.

 

 

References:

Guideline Application for Medical device Advertisement Approval - Requirements

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