The world of advertising is dynamic and ever-evolving, especially when it comes to the promotion of medical devices. Ensuring that these advertisements align with regulatory standards is essential to maintain transparency, credibility, and, most importantly, the safety of consumers and healthcare professionals. Singapore is renowned for its high standards in healthcare and medical device regulation. The Health Sciences Authority (HSA) plays a pivotal role in ensuring the safety and efficacy of medical devices within the country. One crucial aspect of this regulation involves the oversight of medical device advertisements and sales promotions.
In this blog, we've explored the intricate web of HSA regulations governing medical device advertising, as well as the consequences of non-compliance. But, what if you find yourself in a situation where your advertisements are not meeting the regulatory requirements? This blog outlines the necessary steps to address such issues and sheds light on the importance of swift corrective actions.
What is an advertisement ?
The advertiser bears the obligation of ensuring adherence to legal regulations and established guidelines when it comes to the advertising and promotion of medical devices. An 'advertisement' encompasses the act of publishing, circulating, or transmitting any information with the intent to promote the sale or usage of the medical device, employing any medium or format.
Diverse Advertising Platforms
Several media formats that encompass advertising and promotion, all falling within the ambit of advertising and promotional rules and regulations, encompass:
Print media such as newspapers, magazines, journals, and other periodicals
Visual displays like posters and notices
Printed materials including circulars, brochures, pamphlets, and books
Written communications directed towards individuals or organizations
Visual media like photographs and films
Aural broadcasting, television, the internet, and various other media outlets
Public demonstrations that showcase the use of health products
The offering of health product trials to the general public
Direct sales via door-to-door interactions
Promotional events like exhibitions and competitions
Any additional activities intended to introduce, publicize, or enhance the profile, public awareness, or visibility of any medical device for the purpose of promoting its sale or usage.
Advertisements may take on various formats, including flyers, banners, lightboxes, LCD (Liquid Crystal Display) / LED (Light Emitting Diodes) display panels. Additionally, advertisements can manifest on digital interactive media or social platforms like Facebook, blogs, and Instagram. Even information disseminated during press releases and materials employed in product launch events are subject to Advertising Regulations."
HSA's Regulatory Guidelines for Medical Device Advertising and Promotion
The primary regulatory frameworks governing the advertising and promotion of medical devices in Singapore consist of the Advertisement Controls for Health Products ("HP") and the Health Products (Medical Device) Regulations ("the Regulations"). The core objective is to guarantee the dissemination of precise and honest information regarding the products, preventing advertisements and sales promotion activities from deceiving consumers or encouraging unnecessary purchases or use of health products (HP). This plays a cruscial role in enabling both the general public and healthcare professionals to make well-informed decisions when selecting health products."
Anyone, whether a member of the general public or otherwise, can submit feedback or lodge complaints with HSA through the Medical Advertisement and Compliance Monitoring Unit at HSA_MA@hsa.gov.sg. It is imperative to furnish the following details:
Information regarding the publication date and location of the advertisement (including a copy or image of the advertisement).
A description of the concerns or issues identified in the advertisement.
The specific non-compliance aspects, including references to the relevant clauses, provisions, or prescribed requirements."
Fundamental Principles of Medical Device Advertisements
In the realm of medical device advertising, there exist some core principles that every manufacturer must adhere to when creating promotional materials for the Singaporean market. Here are the general guidelines to keep in mind:
Truthfulness: Advertisements must accurately and truthfully represent the nature, quality, and properties of the medical device. They should refrain from using unqualified superlatives and avoid misleading through ambiguity, exaggeration, omission, or any other means.
Substantiation: Any claims made in the advertisement must be backed by scientific evidence. This includes statements, emphases, certifications, awards, unique features, or prominence. Claims such as "Most popular" or "Number One sales" should be supported by market data and be available for submission upon request, including the source of reference.
Accuracy: Recommendations pertaining to the use of the medical device should be stated accurately and in a moderate manner, directly relevant to their properties.
Comparisons: Advertisements should not engage in comparisons with other products unless scientifically proven. If comparative claims are made, they should be presented in a clear and fair manner without criticizing other products.
Indiscriminate Use: Advertisements must not directly or indirectly encourage indiscriminate, unnecessary, or excessive use of the medical device.
Use of Scientific Data: Exploiting public ignorance by including unverifiable scientific data is prohibited. Misuse of research results and unnecessary quotations from technical and scientific publications should be avoided.
Fear and Superstition: Advertisements should not evoke fear or exploit public superstitions.
Language: Medical advertisements should employ simple, understandable language and avoid confusing jargon.
Endorsements and Testimonials from Healthcare Professionals: Testimonials or recommendations from healthcare professionals should not be featured in advertisements.
User Testimonials: If user testimonials are included, they should reflect the typical experience of an average user, align with the medical device's intended purpose, and not imply involvement of fictitious characters as real individuals.
Logos, Initials, and Trademarks: The use of HSA's name, logo, professional group names affiliated with HSA, initials, logos, or trade service marks of any entity should not occur without prior written permission.
Guarantees: Claims of infallibility, being a guaranteed cure, or having magical, miraculous properties should be avoided.
Claims of Safety: There should be no claims or implications that the medical device is 100% safe, free from side effects, or will not cause harm.
Discouraging Medical Advice: Advertisements must not discourage the public from seeking advice from a medical professional.
Conformance with SCAP: All medical advertisements must comply with the Singapore Code of Advertising Practice (SCAP), which is administered by the Advertising Standards Authority of Singapore (ASAS)."
Restrictions of Certain Advertisements
Restrictions on Specific Advertisements Promotions concerning registered medical devices designated for 'professional use only' are prohibited for general advertising, unless they are exclusively distributed to qualified practitioners or included within publications specifically aimed at such professionals. Advertising directed at the general public that makes claims, insinuations, or implications about the device's capacity to prevent, mitigate, or cure diseases or conditions is likewise not permitted."
Advertising criteria for particular Medical Devices Categories
In Singapore, there are stringent advertising requirements for specific categories of medical devices. For instance, contact lenses must only be provided through registered optometrists, in compliance with the Optometrists & Opticians Act. Advertisements for contact lenses should include advisories encouraging individuals to 'visit/consult your optometrist.' Similarly, medical devices intended for supervised supply by specific healthcare professionals, such as doctors or physicians, should incorporate advisories like 'Consult your doctor/physician' as applicable. These requirements are in line with the Singapore Code of Advertising Practice (SCAP) enforced by the Advertising Standards Authority of Singapore (ASAS). SCAP outlines precise mandates, including the necessity of including caveats in advertisements for certain products, which encompass a range of medical devices, among them being condoms, hearing aids, slimming products, and hair and scalp products. Compliance with these guidelines is crucial to ensure responsible and accurate advertising in the healthcare sector.
Corrective Measures for Non-Compliant Advertisements
In the event that advertisements are found to be non-compliant with regulatory requirements, prompt action is essential. First and foremost, it is imperative to cease the dissemination of the non-compliant advertisements immediately. Subsequently, measures should be taken to remove any offending advertisements that have already been published or distributed. To rectify the situation, the responsible party must publish a corrective advertisement as directed by the regulatory authority, which includes specific details such as the content, the medium of publication or broadcast, and the duration for which the corrective advertisement is to be displayed. It is vital to note that these corrective actions are in addition to any potential penalties that may be imposed under the Health Products Act (HPA). Failing to comply with the regulatory order may result in the authority taking further steps deemed necessary to enforce the order and recover reasonable costs and expenses incurred in the process.
Maintaining adherence to regulatory requirements in medical device advertising is a non-negotiable aspect of the healthcare industry. As we've discussed, swift action must be taken if your advertisements are found to be non-compliant. However, ensuring compliance from the outset is even more critical. At Artixio, we understand the complexities and nuances of medical device advertising and can guide you through the intricate landscape of regulatory compliance. Trust us to help you navigate this ever-changing field while promoting your medical devices with accuracy, credibility, and safety in mind.
If you're seeking expert guidance on navigating the complex world of medical device advertising regulations, don't hesitate to reach out to Artixio. Our team of experienced professionals is here to provide you with the expertise and solutions you need to ensure your medical device advertisements meet regulatory standards while effectively reaching your target audience. Contact us today to learn more about our services and how we can assist you in promoting your medical devices in compliance with regulatory requirements. Your success is our priority. Get in touch now to explore the possibilities!