The Medical Device Authority (MDA), the Malaysian authority responsible for medical device regulations, has published updated guidance on advertising rules for medical devices intended to be marketed on the domestic market. The document is intended to assist medical device manufacturers and other parties involved in achieving and sustaining compliance with the applicable regulatory requirements set forth by the Medical Device Act (Act 737).
The recommendations and clarifications provided in the documents are based on the following national regulations on medical devices:
- Medical Device Act 2012 (Act 737);
- Medical Device Regulations 2012; and
- Medical Device (Advertising) Regulations 2019.
However, the authority also mentions that it reserves the right to request additional information besides the scope prescribed under the applicable regulation, should it be reasonably necessary to assess the conformity of a medical device in question with the regulatory requirements in terms of safety and effectiveness. Moreover, in case of any discrepancies between the present guidance and the provisions of applicable legislation, the latter should prevail. The authority is also entitled to make amendments to the present guidance in order to reflect the changes to the respective laws and regulations.
Under the general rule, it is not allowed to advertise medical devices other than the ones duly registered in accordance with the applicable regulatory requirements. Information contained in advertisements should not be misleading or fraudulent.
According to the document, advertising stands for written or spoken words and any pictorial representation or design, used or appearing to be used to promote the sale of medical devices, generally by highlighting the approved device claims. It is stated that such claims should be accurate.
Scope and Key Definitions
The scope of the present guidance covers the regulatory requirements for the advertisement of medical devices irrespective of their regulatory status. At the same time, other types of information, including aspects related to pricing, fall outside the scope of the guidance.
The MDA also provides the definitions of the main terms used in the context of advertisement of medical devices, including the following:
- Advertiser – any person who uses any form or medium, whether printed or electronic, to advertise a medical device including journalists, publishers or public relations agencies, celebrities, web designers or web hosting platforms.
- Home use medical device – a medical device labeled for use in any environment outside a professional healthcare facility and intended for use by healthcare professionals and/or laypersons. For the purpose of this definition, the term layperson covers all persons having no special qualification and knowledge in the sphere of medical device and includes patients themselves, as well as family members. A medical device intended for home use should have the appropriate labeling necessary for the user to be able to use a medical device in a safe and efficient manner.
Advertising Rules in Detail
The present MDA guidance covers all types of advertising activities, including the following:
1. Advertising via the Internet (e.g. banners, mailing, and social media advertising);
2. General marketing (e.g. press releases and indoor displays);
3. Printed materials (brochures, calendars);
As mentioned, the information contained in the advertisement shall be reliable and accurate. It should not entice the use of a medical device that results in additional risks. It is explicitly prohibited to make misleading claims or ones exploiting potential users’ lack of knowledge.
If an advertisement provides incorrect information about a medical device, its functions, features, intended use, or safety-related aspects, such an advertisement should be deemed misleading.
Moreover, an advertisement should contain cautions and warnings the medical device manufacturer finds necessary to communicate to potential users in order to ensure they will use the device in a safe and efficient manner.
All claims contained in an advertisement shall align with the intended purpose of the product indicated by its manufacturer in the course of registration performed prior to placing the medical device on the market. The MDA emphasizes that the medical device should not be promoted for use by groups other than those for which it was originally designed. The claims contained in an advertisement should also be confirmed by scientific evidence collected by the medical device manufacturer.
Aside from the general points listed hereabove, the MDA highlights some specific aspects associated with advertisements for medical devices, such as:
1. Restricted therapeutic claims. The MDA provides the list of illnesses to which the medical device could only provide relief of its symptoms. Hence, any medical device should not be marketed as a product providing treatment for such diseases.
2. Ageing-related claims. It is also prohibited to make claims related to the effects caused by the device in the context of aging and premature aging. According to the document, the physiological aging processes can not be impacted by a medical device to a significant extent.
3. The Brain and its functions. The medical device manufacturer shall not make claims with regard to the impact the device causes on the operations of the brain or memory. A medical device should not be promoted as providing improvement of brain operations and performance.
4. Immunity and other claims the advertisement should not refer to. The list of restricted claims also includes claims stating that a medical device can improve immunity against specific diseases, reduce stress, improve performance in sports, or provide weight management.
5. Device-specific claims. According to the guidance, it is explicitly prohibited to place undue emphasis on the country of origin of a medical device or its manufacturer. The same approach should be applied with regard to “natural” claims, which may be used in advertisements only if the medical device is actually composed of natural materials.
6. Novelty. It is allowed to refer to the novelty of a medical device only if it was placed on the market less than 18 months ago.
7. The authority pays special attention to the claims related to the safety of a medical device. In particular, an advertisement shall not contain any statements that the product has no side effects. All claims related to side effects should be based on the actual data.
8. References to data. Should an advertisement contain any references to statistics data, such data should be provided to the MDA upon request. It is prohibited to make references to data that cannot be validated.
9. Internet Advertising Rules. The MDA additionally outlines specific rules associated with advertising medical devices via the Internet. According to the guidance, all important information should be clearly visible. Should the advertisement be addressed to healthcare professionals only, the appropriate statement should be added as well.
In summary, the present MDA guidance describes the most important aspects associated with the advertisement of medical devices. The document covers matters related to the content of the advertisement, especially in terms of claims made with regard to the safety and effectiveness of a medical device.
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