Singapore Tightens Regulation on Medical Device Advertising

Singapore’s Health Sciences Authority (HSA) drafted a stricter set of guidelines in October 2008 for advertising and promoting medical devices in Singapore. These new guidelines coincide with Singapore’s recent implementation of an updated medical device regulation framework. They are meant to complement the Health Products Act of 2007.

The new guidelines were created to ensure that consumers are not exploited or deceived by unscrupulous advertising. Key points of the guidelines are summarized below. In addition to these guidelines, all advertisements must also comply with the Singapore Code of Advertising Practice (SCAP).

Advertisements must be truthful in stating the nature, quality, and properties of the medical device, and must not mislead the consumer either directly or by implication. All claims, including comparisons with other products, must be substantiated by scientific studies and should not lead to unrealistic expectations of product effectiveness or performance. Also, recommendations for the use of the advertised medical device should not encourage consumers to use the device inappropriately or excessively, or self-diagnose and treat their own illnesses incorrectly.

Furthermore, advertisements may not exploit the ignorance or superstition of the public. They may not provide “scientific data” that consumers cannot verify, or use confusing technical jargon. Also, advertisements should not cause fear and distress in the public or imply that harmful consequences may result from not using the medical device. There should be no claim or implication that the device is safe or will be a cure for any illnesses.

Additionally, there should be no testimonials or endorsements from health professionals, and advertisements should not reference the HSA or imply an endorsement by the HSA. If claims can be substantiated, testimonials from non-professionals may be allowed in certain cases.

Western companies marketing medical devices in Singapore should ensure that any advertisements to consumers comply with these guidelines.