{"id":368223,"date":"2023-11-29T00:19:56","date_gmt":"2023-11-29T05:19:56","guid":{"rendered":"https:\/\/platohealth.ai\/mda-guidance-on-advertisement-approval-overview-regdesk\/"},"modified":"2023-12-02T17:15:15","modified_gmt":"2023-12-02T22:15:15","slug":"mda-guidance-on-advertisement-approval-overview-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/mda-guidance-on-advertisement-approval-overview-regdesk\/","title":{"rendered":"MDA Guidance on Advertisement Approval: Overview | RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The article provides a brief overview of the Malaysian legal framework for advertising healthcare products.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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The <\/span>Malaysian Medical Device Authority<\/span><\/a> (MDA), a country\u2019s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to applications for medical device advertisements approval. <\/span>
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<\/span>The document describes in detail the applicable regulatory requirements set forth under the existing legal framework and also provides additional clarifications and recommendations to be taken into consideration by the parties responsible for medical devices to ensure compliance thereto.
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<\/span>At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. <\/span>
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<\/span>The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Introduction<\/b><\/span><\/h2>\n

The present guidance document issued by the MDA is intended to assist in achieving and sustaining compliance with the requirements of the Medical Device Act (Act 737) and the regulations associated thereto. <\/span>
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<\/span>The document is intended to be used in conjunction with the current laws and regulations introduced in Malaysia. <\/span>
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<\/span>According to the document they include, but are not limited to, the Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, and the Medical Device (Advertising) Regulations 2019. <\/span>
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<\/span>It is also important to mention that the MDA reserves the right to request additional information or set conditions not explicitly mentioned, for regulatory control. <\/span>
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<\/span>While efforts have been made by the authority to ensure the accuracy and completeness of this guidance, in cases of any contradiction, the written law takes precedence.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Advertisement for Medical Device: Requirements<\/b><\/span><\/h2>\n

The guidance specifically addresses the advertisement of medical devices, complementing the provisions of Section 44 of the Medical Device Act 2012 and the Medical Device (Advertising) Regulations 2019. <\/span>
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<\/span>The focus is on promoting good marketing practices and ethical advertising messages that support the quality use of medical devices in a socially responsible manner. According to <\/span>Section 44 <\/b>(1), advertising of medical devices is permissible only if the device has been registered and complies with the requirements set forth under the Act. Furthermore, <\/span>Section 44 <\/b>(2) prohibits any misleading or fraudulent claims in medical device advertisements. <\/span>
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<\/span>The document emphasizes the importance of advertisements as they provide public information and draw attention, influencing consumer decisions and impacting business. <\/span>
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<\/span>Therefore, it guides advertisers to adhere to principles that avoid undue advantage and ensure that advertisements maintain a high standard of proper and reliable information. <\/span>
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<\/span>In terms of content, advertising includes written or spoken words, pictorial representations, or designs that promote the sale of medical devices, typically by emphasizing the approved device claims.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Scope<\/b><\/span><\/h2>\n

The scope of the present guidance covers the requirements for the advertisement of medical devices, categorizing them into those requiring approval and those that do not.<\/span>
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<\/span> It specifies materials that are subject to self-regulation and must comply with the Codes of Advertisement (as specified in MDA\/GD\/0032) without needing explicit approval. <\/span>
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<\/span>This includes advertisements targeted at healthcare facility procurement personnel, healthcare professionals, and materials that only contain product pictorials, brand names, or logos without product claims or descriptions. <\/span>
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<\/span>The document also describes the approach to be applied concerning exact replicas of packaging approved by the Authority and advertorial materials, as well as disease awareness and health education campaigns, contests, and sponsorships.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Terms and Definitions<\/b><\/span><\/h2>\n

To assist the parties involved with interpreting the applicable regulations and following the requirements set forth therein, the document also provides definitions of the key terms and concepts, including:<\/span>
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