Advertising and Promotion Rules for Medical Devices in Singapore

1. Overview

All advertisements and promotional materials for medical devices in Singapore are regulated under the Health Products Act and related regulations. The Health Sciences Authority (HSA) requires that such materials be accurate, balanced, evidence-based, and not misleading to ensure consumer protection and public health. Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

2. Scope of Regulated Materials

Regulated promotional activities include:

• Advertisements in print, broadcast, online, or social media.
• Product brochures, leaflets, posters, and packaging claims.
• Website content, emails, and direct marketing materials.
• Exhibitions, seminars, and trade shows.
• Any form of public communication intended to promote sales or use.

Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

3. Key Requirements for Advertisements

Advertisements must:

• Be truthful and not exaggerate the device's capabilities.
• Be supported by scientific evidence or clinical data.
• Clearly state the intended use and target population.
• Include mandatory information such as device name, registration number (if registered), and warnings/cautions.
• Not make unsubstantiated comparative claims or imply superiority without evidence.
• Avoid fear-inducing or misleading statements.

Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

4. Prohibited Claims and Practices

The following are not allowed:

• Claims of curing, treating, or preventing diseases unless supported by registration.
• Off-label use promotion.
• Testimonials or endorsements implying guaranteed results.
• Before-and-after images without proper context or substantiation.
• Free gifts or incentives that encourage unnecessary purchase.
• Targeting vulnerable groups with unsubstantiated claims.

Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

5. Specific Rules for Different Device Classes

• Registered devices (Class B, C, D): May include claims consistent with the approved intended use and labelling.
• Class A devices and exempt devices: Limited promotion; no disease-related claims allowed unless specifically permitted.
• Unregistered devices: Generally prohibited from advertising to the public except in professional-to-professional contexts with restrictions.

Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

6. Submission and Clearance (Voluntary)

While not mandatory for most promotions, applicants may voluntarily submit materials for HSA advisory review to ensure compliance. This service helps reduce the risk of enforcement actions. Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions

7. Enforcement and Penalties

HSA monitors advertisements and may take action against non-compliant materials, including:

• Issuing directives to cease or correct advertisements.
• Administrative penalties or fines.
• Suspension or revocation of dealer licences in serious cases.

Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/advertisements-promotions