Consultation on Proposed Regulatory Guidelines for Telehealth Devices
Telehealth devices are instruments, apparatus, machines or software (including mobile applications) that are involved in the provision of healthcare services over distance via infocomm technologies, categorised into three broad service areas:
- Clinical services e.g. Tele-radiology, Tele-consultation
- Education e.g. Educational web portals
- Administration e.g. Care management systems
2 A Telehealth device may or may not be classified as a medical device (MD), depending on the intended purpose. This consultation is to provide clarity on the types of Telehealth devices that are MDs. The consultation will also look into the proposed regulatory approach which is largely similar to the regulatory principles for other MDs.
Key Guidelines Under Review
3 A Telehealth device is classified as an MD if it has a medical intended use. Please refer to the consult document below for more information.
4 A Telehealth device intended for a person’s general well-being will not be regulated as an MD, but will be subjected to certain labelling requirements. Please refer to the consult document below for more information.
5 Risk classification of Telehealth devices that are MDs will be classified into one of the four risk classes (risk class A to D).
6 Telehealth devices that are MDs will be subjected to the following MD regulatory controls: Product Registration, Dealer’s Licensing, and Post-market obligations.
7 Regulatory controls for standalone mobile applications that are MDs will be subjected to the same regulatory controls as other MDs. Only standalone mobile applications that are distributed on local online platforms will be regulated.
Your Feedback Is Important
8 HSA welcomes your comments and feedback on the proposed regulatory guidelines on Telehealth devices provided in the consult document below. The consultation window will be from 17 October 2016 to 30 November 2016.
9 Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.
10 Please provide your feedback using the prescribed excel template below and send it to HPRG_feedback@hsa.gov.sg by 30 November 2016.