The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for promoting and advertising medical devices. The document is intended to provide medical device manufacturers and other parties involved in supplying medical devices with additional clarifications and recommendations to be taken into consideration in the course of their business activity.
Table of Contents
The guidance provides a brief overview of the applicable legislation, outlines the most important aspects related to the respective regulatory requirements, and also highlights the general principles for the advertisement of medical devices. The scope of the document also covers corrective measures to be taken with regard to advertising materials failing to comply with the applicable regulatory requirements. The authority explicitly states that the recommendations provided by the guidance are not exhaustive, nor cover all situations that may occur. Hence, it is the sole responsibility of the party responsible for a medical device to achieve and ensure compliance with the applicable requirements.
Advertisements of Specific Categories of Medical Devices
Apart from other aspects, the scope of the present guidance covers the requirements to be applied in the case of specific categories of medical devices. In this regard, the authority emphasizes the following:
- Since, according to the current legislation, Class A medical devices are explicitly exempted from mandatory registration before placing on the market, it would be sufficient for the parties marketing such devices to ensure the way the device is promoted meets its intended use as prescribed by the manufacturer. In particular, the claims made with regard to the device, its safety, and effectiveness should not contradict specifications provided by the medical device manufacturer.
- In the case of medical devices placed on the market under certain restrictions, references to such restrictions should be provided in the advertising materials as well. For instance, medical devices intended for supervised supply by specified healthcare professionals should feature advisories like “Consult your doctor/physician” as applicable.
- Additional requirements are also applied in accordance with the Singapore Code of Advertising Practice (SCAP) administers by the Advertising Standards Authority of Singapore (ASAS). In particular, specific requirements should be applied in case of hearing aids or hair and scalp products.
Corrective Measures in Relation to Contravening Advertisements: Key Points
As mentioned, the guidance also provides additional clarifications on regulatory requirements for corrective measures to be taken by a responsible party in order to ensure compliance with the provisions of the applicable legislation.
First, the authority states that as part of compliance review and investigation, [the entity responsible for a medical device placed on the market] may be required to furnish copies of MD advertisements which have been advertised or about to be advertised to the Authority within a specified time. When required, the Authority will communicate with the advertiser by a written notice on the submission.
Should the HSA identify non-compliance with the applicable regulatory requirements in the sphere of medical device advertisements and sales promotions, it is entitled to require the entity responsible for a medical device in question to:
- Cease the advertising activity;
- Ensure complete withdrawal (removal) of non-compliant marketing materials;
- Issue the appropriate corrective advertisement that should contain the following elements:
- The content of the corrective advertisement,
- The medium where the corrective advertisement is to be published/broadcast,
- The duration for which the corrective advertisement is to be published/broadcast.
It is stated that the HSA is entitled to require the party responsible for a medical device subject to review to implement one or all the measures outlined hereabove.
The authority also mentions that in accordance with the applicable legislation, the appropriate penalties and fines could be imposed on the entity failing to comply with the requirements on advertising and promoting medical devices. Moreover, should such entity fail to implement the measures as requested by the authority, the latter reserves the right to take additional steps it finds reasonable to implement such measures and then claim the expenses incurred in this regard.
Content of Corrective Advertisements
The guidance also describes in detail the content for corrective advertisements to be issued by a responsible party in order to restore compliance with the applicable regulatory requirements. In particular, such an approach should be applied if the initial advertisement contains incorrect or inaccurate information regarding the safety, effectiveness, or quality of a medical device placed on the market, provided such non-compliance could result in inappropriate prescribing or use of a medical device. It is further stated that in instances where a corrective advertisement is assessed to be necessary, the Authority will communicate the requirements, including the content, size and placement, and duration of the corrective advertisement to the affected companies via a written notice. The authority emphasizes the importance of ensuring that corrective advertisements are targeted at the audience who saw the offering advertisement.
Furthermore, the guidance prescribes the particular format to be followed when issuing corrective advertisements, namely:
- An expression of regret and apology;
- A statement informing that the present correction is requested by the regulating authority, and also indicating the particular medical device in question;
- Information about non-compliance with the applicable legislation, including the accurate and relevant information that should be communicated;
- Additional details on the way the non-compliance advertisement was made publicly available;
- Contact details of the entity responsible for a medical device.
Feedback on Advertisements
According to the guidance, all complaints regarding the format and content of advertising materials used to promote medical devices, as well as any feedback related thereto, should be filed to the Medical Advertisement and Compliance Monitoring Unit. In order to ensure prompt review and response, all requests should contain such elements as:
- Information on place and time the advertisement in question was published;
- Details of the concerns related to the advertising materials, including the references to the particular clauses or statements.
Apart from providing recommendations described above, the present HSA guidance also outlines the particular claims to be used with regard to specific Class A medical devices, which are, as mentioned, exempted from mandatory registration before placing on the market in accordance with the applicable regulatory requirements. The admissible claims are divided into groups depending on the particular medical device in question.
In summary, the present guidance issued by Singapore’s regulating authority highlights the most important aspects associated with advertising and promoting medical devices marketed in the country. The document provides additional clarifications regarding the regulatory requirements and indicates the key points to be taken into consideration by the parties involved.
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