The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to advertisements and sales promotions of medical devices. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the applicable legislation in the sphere of advertising, as well as recommendations to be followed. The guidance is based on the provisions of the Health Product Act (“HPA”) and the Health Products (Medical Device) Regulations (“the Regulations”).
Table of Contents
According to the guidance, the objective of advertisement controls for health products is to ensure that accurate and truthful information about the products is disseminated and to ensure that the advertisements and sales promotion activities do not mislead consumers or induce unnecessary purchase or consumption of the health products. Failure to comply with the requirements in the sphere of advertising and promotion could result in fines and other sanctions to be imposed as prescribed by the applicable legislation.
First, the document provides the definitions of the most important terms and concepts used in the document, including the following:
- “Advertisement” stands for the publication, dissemination or conveyance of any information for the purpose of promotion, whether directly or indirectly, the sale or use of that health product by any means or in any form. Hence, the main element here is the purpose – in the case of an advertisement, the information about a medical device is communicated mainly to facilitate its sale. The scope of advertisement covers various forms of making information available, including printed materials, visual materials, presentations, etc. The authority also states that the use of visual elements associated with the particular medical device for the purpose of its promotion should be considered an advertisement.
- “Professional use only” is a specific category of medical devices which are initially intended to be used only by healthcare professionals having necessary qualifications and knowledge or under the supervision of such healthcare professionals. In most jurisdictions, there are special rules to be applied in the case of advertising medical devices intended to be used by healthcare professionals only.
- “Qualified Practitioner” refers to a registered medical practitioner under the Medical Registration Act; or a registered dentist under the Dental Registration Act whose name appears in the first division of the Register of Dentists.
Requirements for Advertisements of Medical Devices
According to the guidance, all the parties involved in the advertising and promotion of medical devices should achieve and sustain compliance with the applicable regulatory requirements set forth under the aforementioned legislation.
Under the general rule, prior approval for advertising materials intended to be used to promote medical devices is not required. At the same time, the entity using such materials is responsible for ensuring compliance with the applicable regulatory requirements. In particular, there is an explicit prohibition of marketing a product that is not a medical device as a medical device. The information regarding the product should not be misleading for the customers. All the statements and claims made with regard to medical devices, their functions, features, and characteristics should be supported by relevant objective evidence. The authority also states that if a medical device is registered, all statements made should match the indications and instructions for use provided in the course of registration, while information beyond this scope should not be included. In the case of medical devices that are exempted from registration, it would be sufficient for the information used in advertising to comply with the product specifications. Thus, the entity promoting medical devices should ensure the advertisement complies with any and all applicable requirements.
The authority also pays special attention to claims regarding a medical device and its functions and features. As mentioned, all such statements should be substantiated by evidence, especially in the case of making references to awards for specific features that are unique for medical devices. All the information should be provided in a way that makes it clearly understandable by the intended users. If there are statements referring to the device as “most popular,” “number one sales,” the appropriate market data should be in place, as it could be requested by the authority in order to verify the accuracy and relevance of these statements. In the case of references to awards, the details about the certifying body that has issued the award should be provided.
The guidance also outlines the scope of prohibited activities in the sphere of advertising medical devices. For instance, it is stated that medical devices labeled for “professional use only” should not be advertised to the general public irrespectively of their regulatory status (whether they are registered or not). The means of communicating the advertising of “professional use only” devices should ensure it will be addressed to the relevant audience. In particular, such an advertisement could be contained in publications that are aimed at healthcare professionals.
Also, there are specific requirements regarding the statements made in the advertisement with regard to the treatment of certain specific diseases and conditions included in a special list provided by the authority. Such statements could be made only with regard to medical devices intended for professional use only.
General Advertising Principles
In order to assist advertisers in complying with the applicable regulatory requirements, the HSA also provides an overview of the general principles for advertisements of medical devices. These principles include the following:
- Discourage from medical or professional advice. In no event should an advertisement promote self-diagnosing or self-treatment of severe diseases. It should not be claimed that the use of a medical device could substitute professional advice and treatment or medical intervention.
- Truthfulness. As mentioned before, any claims and statements made in an advertisement should be based on the actual evidence.
- Inappropriate or Indiscriminate Use. Advertisements should not directly or indirectly encourage inappropriate, indiscriminate, unnecessary or excessive use of medical devices.
- Use of Scientific Data. It is strictly prohibited to make references to scientific data the general public has no access to.
- Comparative Claims. It is also prohibited to make negative statements regarding other medical devices placed on the market. Any comparison should be non-biased and objective.
- Causing Fear and Alarm. The advertisements should not exploit the lack of knowledge. It is strictly prohibited to make statements that customers would incur severe consequences without a device.
- Guaranteed Results and Claims of Safety. The advertisement should neither state the positive result is guaranteed, nor assure the customer the device is 100% and has no side effects.
- Recommendations and Endorsement by Government of Public Authority. It is prohibited to use the logo of HSA for marketing medical devices as this could be treated as misleading customers.
- Recommendations and Endorsements by Healthcare Professionals. The advertiser shall not state that a medical device is recommended by any healthcare professionals.
- Advertisements of Specific Categories of Medical Devices. The document also describes the rules to be applied for specific medical devices.
In summary, the present HSA guidance highlights the most important aspects related to advertising medical devices in Singapore. The document provides clarifications regarding the applicable regulatory requirements and outlines prohibited activities.
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