October 6, 2017
On August 2017, HSA has finalized the Guidelines for Telehealth Products to provide a clear regulation on Telehealth products. Telehealth products refer to "instruments, apparatus, machines or software (including mobile applications) involved in the provision of healthcare services over physically separate environments via information communication technologies (including mobile technology)." They are categorized into four broad domains:
3) tele-monitoring, and
The guideline clarifies the categorization of telehealth products as medical devices, stating that the intended use of the telehealth products will determine whether or not it will be regulated as a medical device. Telehealth products which are intended for the “investigation, detection, diagnosis, monitoring, treatment or management of any medical condition, disease, anatomy or physiological process” are considered to be medical devices and are subject to HSA’s regulations.
Likewise, the Risk Classification Guideline for Telehealth Medical Devices is included in the guideline, as well, which is dependent on the nature and intended functions of the device.
Figure 1. Examples of Telehealth Medical Devices of various risk classes
Telehealth medical devices are subject to the following medical device regulatory controls:
1) Product Registration,
2) Dealer’s License Requirements, and
3) Post-Market Obligations.
Complete flowcharts of the categorization and risk classification as well as the list of applicable HAS guidelines, are included in the complete guideline.
HSA will also be releasing an Immediate Registration Route for Class B or Class C standalone medical device applications which are already registered with one of the five reference authorities, given that the applications have no safety issues globally,:
i) Health Canada,
ii) Japan’s Ministry of Health, Labour and Welfare,
iii) United States Food and Drug Administration,
iv) Australian Therapeutic Goods Administration,
v) European Union Notified Bodies