EMERGO SUMMARY OF KEY POINTS:

• The Singapore Health Sciences Authority (HSA) has issued new clarification and an FAQ regarding how telehealth products and mobile medical apps are regulated in the country.
• HSA plans an immediate market access pathway for mobile medical apps that have already registered in the US, Canada, Australia, Europe and/or Japan.
• Singapore’s general regulatory approach to telehealth resembles that of the US FDA.

Medical device regulators in Singapore have published new regulatory guidelines to clarify how they oversee mobile medical apps and telehealth products and explain which types of these technologies qualify as medical devices.

The Health Sciences Authority’s (HSA) guidelines, first proposed in 2016, distinguish between telehealth products—hardware, software and mobile apps—and telehealth services, which do not fall under HSA oversight. HSA addresses questions regarding its telehealth regulatory approach in a recent FAQ, where the agency also discusses its pending Immediate Registration Route for mobile medical apps that have already obtained market authorization in either the US, Europe, Japan or Australia.

When does HSA consider a telehealth product a medical device?

On a high level, Singaporean regulators consider a mobile app or telehealth product to qualify as a medical device if that product can “be used for purposes of investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process.”

HSA also provides examples of telehealth products and services that it does not consider medical devices: Smartphones and tablets not intended for medical use; online medical educational content; video monitoring and surveillance equipment used in healthcare facilities; apps for calculating body mass index (BMI), water content or other non-diagnostic or therapeutic data; and software used for storage or retrieval but not processing of medical data.

How HSA addresses wearables and general well-being telehealth products

As in the US and other medical device markets, Singaporean regulators must draw a fine line between mobile medical apps and products that do function as devices and those that do not.

To distinguish between telehealth products that do qualify as medical devices and those that don’t, HSA considers whether a manufacturer or developer intends its product for a medical use. For products that are not intended for a medical use but can perform that function, the product owner must include a clarification statement on the product label to avoid misleading users regarding intended use.

Defining standalone mobile medical apps

HSA defines standalone mobile medical apps as “mobile applications with medical purpose that are intended to function by themselves and are not intended for use with other hardware medical devices.”

Mobile medical apps intended for medical use do fall under HSA oversight as medical devices; general health and lifestyle mobile apps such as those used for fitness tracking are not regulated as medical devices. Medical app developers already familiar with the US Food and Drug Administration’s approach to these products should find no surprises regarding HSA's stance here.

Immediate Registration Route for mobile medical apps

Finally, HSA is planning to launch an expedited market access pathway, the Immediate Registration Route, for mobile medical apps that have already registered as devices with one of five reference regulators: the US FDA, European Notified Bodies, the Australian Therapeutic Goods Administration, the Japanese Ministry of Health, Labour and Welfare, and Health Canada.

Mobil medical apps already approved by at least one of these reference agencies will be able to gain immediate access to the Singaporean market. However, HSA has not set a firm date yet as to when this program will become available.

Related Emergo resources for Singapore:

• Singapore HSA medical device registration and approval consulting
• Singapore Registrant in-country representation
• Singapore HSA medical device classification support
• Video overview: Singapore medical device registration