The new article describes in detail the approach to be applied with respect to applications for advertisement approval to be submitted by interested parties.
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The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to applications for medical device advertisement approval.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in the supply of medical devices in order to ensure compliance thereto.
The authority also reverses the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Advertisement Approval Process
According to the guidance, the process for obtaining approval for medical device advertisements is a vitally important regulatory step, particularly for devices intended for home use and those aimed at the general public.
This stringent process, governed by the regulating authority, ensures that the information disseminated to the public is accurate and in compliance with established health regulations.
Detailed Application Submission Procedure
As further explained by the MDA, in order to initiate the approval process, advertisers must submit an “Application Form for Medical Device Advertisement” which is outlined in Annex A of the present guidance.
This form is to be provided in hard copy and delivered either in person or through post/courier services.
The submission should include two coloured versions of the proposed advertisement or the script. In cases where the advertisement involves audio or video content, a detailed storyboard or suitable media storage device, such as a thumb drive, must be included, if requested by the authority.
Accessibility of the Application Form
The application form is readily available on the authority’s official website (www.mda.gov.my), making it accessible to all potential applicants.
This online availability simplifies the process for advertisers to obtain and complete the necessary documentation for their advertisement proposals.
Specifics of Multilingual and Multimedia Advertisements
A single application can be used for advertisements with identical content but in multiple languages and across various media forms.
Separate applications are required for advertisements with audio or video content that will be broadcast on television, radio, or the Internet.
Advertisements can feature up to five different medical devices, however, the application approval will depend on the content type.
For multiple devices under a similar category, a single application can suffice.
Translation Requirements for Advertisements in Other Languages
For advertisements not in Bahasa Malaysia or English, a sworn translation must be provided.
This translation must be verified by a recognized body such as the Malaysian Institute of Translation and Books or equivalent professional translation services.
This requirement ensures that the information presented in the advertisement is accurate and comprehensible in the respective languages.
Processing Fee Details and Payment Instructions
Each application must be accompanied by a processing fee of RM 1,000.00.
The fee is payable exclusively through a bank draft, with specific instructions on the details to be included in the draft.
Notably, cash payments are strictly prohibited, and the processing fee is non-refundable under any circumstances.
Issuance of Approval and Conditions for Validity
Following a thorough review, if the authority finds the application satisfactory, it will issue an approval number specific to the advertisement.
The aired advertisement must be identical to the version approved by the Authority. The validity of this approval is directly linked to the expiry of the medical device registration.
The authority additionally emphasizes that in case the medical device claims or registration information changes, the advertisement will become invalid, necessitating a new application.
Protocol for Post-Approval Changes
Significant changes to the content or language of an approved advertisement require a new application for approval.
At the same time, minor editorial adjustments or changes in images do not demand a new application, unless these changes affect the advertisement message or claims about the medical device.
In summary, the guidelines issued by the MDA are designed to ensure that advertisements for medical devices are rigorously scrutinized for accuracy, relevancy, and compliance with health and safety standards.
Advertisers must follow these protocols to a letter in order to obtain and maintain approval for their medical device advertisements, thereby safeguarding public health and maintaining the integrity of medical information.
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