The article provides an overview of the Singaporean regulatory requirements for advertising medical devices marketed in the country.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for medical device advertisements and sales promotion. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration when placing medical devices on the market and conducting marketing campaigns associated thereto. The authority also mentions that provisions of the guidance are non-binding in their legal nature, are not intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. The current document represents the second revision of the guidance issued by the HSA.
According to the guidance, the objective of advertisement controls for health products (“HP”) 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 purchases or consumption of the HP. The authority expects that the above will be helpful for healthcare professionals and customers to make informed decisions about the healthcare products they are going to use.
The document provides additional clarifications regarding the existing regulatory requirements outlined in the Health Products Act (“HPA”) and the Health Products (Medical Device) Regulations (“the Regulations”). It is important to mention that in case of any discrepancies with the provisions of the aforementioned regulations the latter should prevail. The authority also states that the examples contained in the guidance are not exhaustive and are provided for illustrative purposes only.
As it was mentioned before, the key regulatory requirements in the sphere of marketing medical devices are outlined in the HPA and Regulations. Both of them prescribe the requirements to be followed by medical device manufacturers and other parties involved in the marketing and supply of medical devices, as well as the fines and penalties the violating parties could be subject to.
Terms and Definitions
To assist the industry with interpreting and following the regulatory requirements under the existing regulatory framework, the document provides definitions of the most important terms and concepts used in the context of marketing and advertising activities related to medical devices including, inter alia, the following ones:
- Advertisement, which for the guidance stands for any information for promotion, whether directly or indirectly, the sale or use of that health product by any means or in any form, including the following:
- Publication in a newspaper, magazine, journal, or other periodicals;
- Display of posters or notices;
- Circulars, handbills, brochures, pamphlets, books, or other documents;
- Letters addressed to individuals or bodies corporate or unincorporated;
- Photographs or cinemagraph films;
- Sound broadcasting, television, the Internet, or other media;
- Public demonstration of the use of the health product; and
- Offer of trials of the health product to members of the public.
As further explained by the HSA, the above definition is quite broad and covers various forms of advertisement including, inter alia, such forms as:
- Flyers, banners, and light boxes;
- LCD / LED display panels;
- Advertisements on digital interactive media or social media channels, e.g., Facebook, Blogs, Instagram;
- Press releases and materials used in product launch events.
Under the general rule, the use of a name, logo, or any other distinguishing element of the device for its promotion is considered to be an advertising activity. Sales promotion stands for an activity undertaken to increase public awareness of the device.
The document also provides definitions of such terms as “professional use only medical device” and “qualified practitioner”. These definitions are used in the context of medical devices that are intended to be used by a limited range of customers and, consequently, should be promoted only within this range.
Advertising Requirements: Key Points
Any advertising activities undertaken in Singapore should be conducted under the respective requirements outlined in the HPA and Regulations – the principles they provide allow information and/or advertisements to be disseminated to create awareness and enable consumers to take better ownership of their own health choices.
Under the general rule, advertisements of medical devices are not subject to prior approval. At the same time, a party responsible for them is obliged to assure compliance with the respective regulatory requirements as prescribed by the HPA and the Regulations.
First of all, it is stated that any product should not be advertised as a medical device, or as one that operates as a medical device unless it is a medical device. Furthermore, it is explicitly prohibited to provide false or misleading information regarding the medical device, its functions, and features, safety, effectiveness, as well as components thereof. Any claims made by the manufacturer or other party concerning a medical device should be supported by objective evidence.
In the case of products registered as medical devices, all the claims and statements made concerning such products should be in line with the respective indications and instructions for use (IFU). The authority additionally emphasizes that information beyond the details provided in the course of registration should not be used in advertising materials. If the product in question is subject to an exemption from registration, information about this product should be in line with the specifications provided by its manufacturer.
In summary, the present HSA guidance provides an overview of the country’s legislation establishing the regulatory requirements in the sphere of advertising healthcare products. The document also defines the term “advertisement” and highlights the key points associated thereto.
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