The article provides a brief overview of the Malaysian legal framework for advertising healthcare products.
Table of content
The Malaysian Medical Device Authority (MDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to applications for medical device advertisements approval.
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.
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.
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.
Introduction
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.
The document is intended to be used in conjunction with the current laws and regulations introduced in Malaysia.
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.
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.
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.
Advertisement for Medical Device: Requirements
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.
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 Section 44 (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, Section 44 (2) prohibits any misleading or fraudulent claims in medical device advertisements.
The document emphasizes the importance of advertisements as they provide public information and draw attention, influencing consumer decisions and impacting business.
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.
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.
Scope
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.
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.
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.
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.
Terms and Definitions
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:
- Advertisement: Any statement, pictorial representation, or design intended to promote the use or supply of medical device-related items.
- Advertiser: Individuals or entities using any form or medium to advertise a medical device.
- Advertorial: An advertisement in the style of an editorial or journalistic article.
- Healthcare Professional: Defined as practitioners in various medical fields as listed in the Allied Health Professions Act 2016 (Act 774).
- Home Use Medical Device: Devices intended for use outside professional healthcare facilities by professionals or lay persons.
- Editorial Changes: Minor clarifications in advertising material that do not change its substantive meaning.
General Requirements
The document explicitly states that only registered medical devices may be advertised, and all advertisements must be free from misleading or fraudulent claims.
The responsible party for a medical device advertisement is identified as either the manufacturer or their authorized representative.
They may delegate advertisement responsibilities to private individuals or third parties, ensuring compliance with regulatory requirements.
Advertisements must include specific information, such as the statement “Registered under Act 737”, the medical device registration number, and, where necessary, the advertisement approval number.
Cautionary statements for medical devices are encouraged for clarity in advertisements.
Standards for Ethical Advertising
As further explained by the authority, all advertisements must adhere to the Code of Advertisement (COA)-MDA/GD/0032 guidance document, ensuring ethical advertising standards are met.
This section prescribes the commitment to maintaining high ethical standards in the promotion and sale of medical devices, safeguarding public interest and well-being.
Conclusion
In summary, the present MDA guidance provides a brief overview of the medical device advertising requirements set forth under the existing legal framework.
The document highlights the key points to be taken into consideration in order to ensure the information communicated through advertising materials is clear and accurate.
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