The proposed regulatory guidelines for telehealth devices by the Health Sciences Authority (HSA) for public consultation has been closed recently on 30 November 2016. The guidelines is intended to provide clarity on the types of Telehealth devices that is considered as a medical device. The guidelines also provide better information on the proposed regulatory approach and requirements by HSA for such devices.
Telehealth devices are instruments, apparatus, machines or software (including mobile applications) that are involved in the provision of healthcare services over distance through info communication technologies. And this is categorised into three broad service areas:
• Clinical services e.g. Tele-radiology, Tele-consultation;
• Education e.g. Educational web portals; and
• Administration e.g. Care management systems.
In order for a telehealth device to be classified as a medical device, the authority will depend on the intended purpose of the device. The intended use is based on the information provided by the Product Owner or the manufacturer of the device.
According to HSA, if the intended use of a Telehealth device is for:
i) the diagnosis of disease or medical conditions, or ii) the cure, mitigation, treatment, or iii) prevention of disease, or iv) is intended to affect the structure or any function of the body of humans, then it is a medical device and is subject to HSA’s regulatory control. For Telehealth devices that is intended for general well-being or lifestyle purposes, it will not be regulated as a medical device. Manufacturers are however required by HSA to include a “clarification statement” (or equivalent) on their labels. This is for the end user of the device to be made aware that the device should not be treated as a medical device. As for Telehealth devices that falls under the medical device category, there are risk classification involved as with all other medical devices. There are four Class A-D devices and it depends on the nature of the device and its intended functions. Higher risk device can be those that is intended to monitor or predict any disease or medical conditions whereas a lower risk device can be those devices which just displays a data. The former is considered as a higher risk as patient health and safety could be jeopardised should the device not function as intended. There is a proposed regulatory guidelines for telehealth devices and those devices that falls under the “medical device” classification will be subjected to the following medical device regulatory controls:
i} Product Registration; ii) Dealer’s licence requirements; and iii) Post-market obligations.
Click here for more information on the guidelines.