1 November, 2016
The Health Sciences Authority of Singapore ("HSA") is conducting a public consultation on new regulatory guidelines for Telehealth Devices, which "instruments, apparatus, machines or software (including mobile applications)
However, if it is intended for the diagnosis or treatment of disease / medical are that are involved in the provision of healthcare services over distance via infocomm technologies".
A Telehealth device may or may not be classified as a medical device, depending on its intended purpose. For instance, if it is intended for a person's general well-being, it will not be considered a medical device.
However, if it is intended for the diagnosis or treatment of disease / medical conditions, then it will likely be regulated as a medical device.
The proposed regulatory guidelines set out labelling requirements which Telehealth devices (that are not regulated as medical devices) must comply with. Telehealth devices that are classified as medical devices will be regulated as medical devices, and must also comply with requirements for product registration, dealer’s licensing, and post-market obligations. The draft regulatory guidelines can be found on the HSA's website here.
Interested parties may provide their feedback using the HSA's excel template found on the above website, and submit it to HPRG_feedback@hsa.gov.sg by 30 November 2016.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow
andy.leck@bakermckenzie.com
