The new article describes in detail the main principles to be followed when advertising medical devices in Singapore.
The Health Sciences Authority (HSA), Singapore’s regulator agency in the sphere of healthcare products, has published a guidance document dedicated to advertising and promotion of medical devices. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The scope of the guidance covers, inter alia, the general principles for advertisements of medical devices the parties involved are encouraged to follow in order to ensure that advertisement claims do not convey misleading messages that could lead to inappropriate use of the product or bring about undue harm to the public. The document highlights the key aspects to be considered in order to ensure compliance with the said principles.
Discourage From Professional Advice
First of all, the authority states that advertisements of medical devices should not directly or indirectly, cause the reader to self-diagnose or self-treat and serious diseases. In particular, advertising materials should not contain statements that will entice potential customers to use the device without consulting with a healthcare professional. Furthermore, it should not be stated that a medical device could be used instead of a surgical operation which is usually required in a specific situation.
Any and all claims made by the medical device manufacturer or any other party involved in its promotion should be based on the sufficient scientific evidence collected in an appropriate way ensuring its accuracy and reliability. All the functions and features of a product should be clearly described. The authority explicitly states that any advertising materials used should not directly or indirectly mislead the reader or give rise to any unrealistic expectations with regard to the safety, quality or efficacy of the medical device by:
- Through emphasizing certain information,
- Omitting information,
- Being ambitious,
- Making exaggerated claims e.g., “the only”, “longest lasting”, “works the fastest”, or
- Comparison with other categories of products.
The HSA additionally emphasizes that superlatives or exaggerated claims should not be used in any materials used to advertise medical devices intended to be marketed in the country.
Inappropriate or Indiscriminate Use
According to the guidance, advertisers shall make sure the advertising materials do not contain any claims enticing potential customers to use the product in an inappropriate way. Furthermore, it is also important to ensure there is nothing encouraging unnecessary or excessive use of medical devices.
Use of Scientific Data
The authority acknowledges the limited knowledge the public has regarding medical devices, the way they operate, key safety- and performance-related aspects, and other matters that are important in the context of medical devices. In order to ensure the interests of potential customers are protected, the authority explicitly prohibits exploiting their ignorance and credulity, especially when it makes references to scientific data that cannot be validated by laypersons. It is also stated that advertisements should not misuse research results or make unnecessary quotations from technical and scientific publications.
Another specific aspect related to advertising medical devices is related to comparative claims when advertisers use a comparison of several products in order to promote one of them. According to the guidance, it is not allowed to unfairly attack other products, while any statements made in the context of such comparison should not mislead potential customers regarding any of the products.
Causing Fear and Alarm
The document also states that when promoting a medical device, advertisers should not directly or indirectly cause fear, alarm, distress to the customers or abuse the trust, exploit the lack of knowledge of any customer in advertisements by:
- Omitting information, or
- Being ambiguous.
In this respect, the authority explains that the statements included in advertising materials should not create an impression that potential customers will suffer more severely without the medical device being promoted. This includes any statements made in order to cause fear, alarm, or distress.
Guaranteed Results and Claims of Safety
As it was mentioned before, it is important to ensure that advertising materials do not contribute to the misperception of a medical device by its potential customers. The main idea is that the customers should understand the risks associated with the products and all related aspects. Hence, advertisers are strictly prohibited from making statements that:
- The device is 100% safe and has no side effects / cannot cause harm (information about the risks should be provided instead); and
- Positive result is guaranteed if the device is used, and it is significantly better than in case of any other treatment option applied.
Recommendations and Endorsements
According to the guidance, advertisers should also be careful when referring to any kind of endorsement. First of all, the authority states that it is strictly prohibited to promote medical devices by making statements that this device is in any way promoted or supported by the Government or any state authority. For the same reason, any visual elements attributed to the HSA should not be used when promoting medical devices intended to be marketed in Australia.
Apart from this, it is also not allowed to state that the product is recommended by healthcare professionals. In case healthcare professionals or institutions are involved, advertisers should ensure this will not create an impression of endorsement.
In summary, the present HSA guidance describes in detail the main principles to be followed with respect to the advertisement of medical devices. The document highlights the key points to be taken into consideration in order to ensure advertising materials and any claims contained therein do not misrepresent the device promoted.
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