The new article covers the aspects related to the device-specific advertising requirements, as well as to the corrective measures to be taken with respect to non-compliances identified.

The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to medical device advertisements and sales promotion. The document is intended to provide non-binding recommendations to be considered by all the parties involved in operations with medical devices, as well as additional clarifications regarding the existing regulatory requirements. At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. 

The scope of the guidance covers, inter alia, the general principles for the advertisement of medical devices. 

 

Special Categories of Medical Devices 

According to the guidance, there is a set of principles to be applied with respect to advertisements of specific categories of medical devices. The device-specific principles described in the guidance include, inter alia, the following ones: 

  • Class A medical devices. Under the general rule, such products are exempted from registration requirements. Nevertheless, according to the guidance, dealers shall be mindful and exercise due diligence in making product claims and advertising for their products; presentations and advertisements for the intended use of a medical device must not deviate from the Product Owner’s specifications. It is also important to mention that one of the appendixes to this guidance provides a non-exhaustive list of acceptable claims for Class A medical devices. 
  • Another category described in the guidance covers medical devices with supply restrictions. As explained by the HSA, for the products subject to certain supply restrictions specific advertising rules should apply as well. For instance, it is stated that contact lenses must be supplied via registered optometrists and in accordance with the Optometrists & Opticians Act. Another example states that medical devices subject to supervised supply should bear an indication “Consult your doctor/physician”. 
  • The authority also mentions that specific requirements are to be applied in accordance with the Singapore Code of Advertising Practice (SCAP) administered by the Advertising Standards Authority of Singapore (ASAS). The said code sets forth specific requirements for advertisements for certain categories of healthcare products, such as condoms, hearing aids, slimming products, hair and scalp products. 

Corrective Measures 

The scope of the guidance also covers the aspects related to the corrective measures to be taken with respect to contravening advertisements. Under the general rule, a party involved in advertising activities related to medical devices could be requested to provide samples of advertising materials used. Upon review of such materials, the authority may request corrective measures to be taken. In particular, should the authority identify non-compliance with the applicable requirements for advertisements for medical devices, it may request a responsible party to: 

  • Stop the advertisement with immediate effect;
  • Take reasonable measures to remove the offending advertisements that have been published / distributed;
  • Publish a corrective advertisement in a manner and containing information as specified by the Authority, which may include, but not limited to the content of the corrective advertisement, the medium where the corrective advertisement is to be published / broadcast; and the duration for which the corrective advertisement is to be published / broadcast. 

Apart from requesting the aforementioned corrective actions to be taken, the authority may impose fines and penalties as set forth under the existing legislation. Furthermore, should a party responsible for the device in question fail to fulfill the requests issued by the authority, the latter may take additional enforcement actions and then recover the costs associated thereto. 

 

Corrective Advertisements: Required Content 

According to the guidance, a corrective advertisement will be required in case the initial one provides inaccurate information or claims with respect to the product in question, its functions, and features, as well as the safety and effectiveness when used for the intended purpose specified by the manufacturer, especially in situations when such incorrect information could impact the medical decision-making process and result in incorrect actions taken based on it. 

If the authority finds it necessary to issue a corrective advertisement, it will notify the responsible party and outline the requirements to be taken into consideration in this respect. Such information will be communicated to the parties involved by the virtue of a written notice issued by the authority. 

Under the general rule, corrective advertisements should be published in the same way as the initial ones in order to ensure reaching the same target audience exposed to the initial advertisements. As further explained by the authority, when publishing corrective advertisements, the following structure should be followed:

  1. An expression of regret and apology;
  2. Opening statement (this should clearly indicate that this is a corrective statement issued at the order of the HSA and the product concerned);
  3. Statement on the breach (this should outline how the advertisement was in breach of the Act / Regulations and give a description of the correct facts);
  4. Description of the case (when and where the offending advertisement was placed); and 
  5. Contact information (details of the company contact should readers have any further questions about these matters or about the product). 

In summary, the present HSA guidance highlights certain device-specific principles to be followed with respect to advertisements for class A medical devices or devices subject to restrictions of supply. Apart from this, the document describes in detail corrective measures the authority is entitled to request the responsible party to take in case of advertisements non-complying with the applicable regulatory requirements. 

 

Sources:

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-08-r2-guidance-on-medical-device-advertisements-and-sales-promotion.pdf 

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