Singapore’s Health Sciences Authority (HSA) has announced changes to its legislation and regulations designed to facilitate access to certain low-risk medical devices and standalone mobile applications. The changes will also clarify current policies and requirements for telehealth devices (such as smart heart-rate trackers) and high-risk devices such as implants and injectable dermal fillers.
The changes, effective June 1, 2018, are designed to safeguard patient health and safety while improving access and innovation. A number of operational and developing industry business models are targeted.
Faster Market Access
Registration will no longer be required for Class A sterile devices, which include sterile examination gloves and sterile intravenous sets. Instead, such devices will now only need to be listed online on HSA’s Class A database.
Furthermore, Class B devices (such as contact lenses and hearing aids) that are either (a) certified by two “reference regulatory agencies” (the relevant regulators from Canada, Japan, the U.S., Australia and the EU) and raise no safety concerns worldwide, or (b) approved by one reference regulatory agency and have three years of marketing history will be granted immediate access to the market under the immediate registration route.
Immediate market access under the immediate registration route will also be granted to Class B and C standalone mobile medical applications (e.g., for the calculation of insulin dosage) that have been approved by at least one reference regulatory agency and raise no safety concerns worldwide.
These changes are intended to expedite consumer access to low-risk devices by streamlining the marketing authorization process.
Clarifying Regulatory Controls
The HSA also clarified that telehealth devices intended for wellbeing or lifestyle purposes, such as heart-rate trackers in smart watches and phones, will not be regulated. Telehealth devices created for medical purposes will be regulated as devices.
The Health Products Act 2008 will now expressly specify that high-risk devices designed for alteration of the anatomy or appearance, such as injectable dermal fillers, implants and invasive fat removal devices, are “medical devices” for the purposes of the act.
Training will now also be mandatory for users of more complex devices that require particular skills and knowledge for safe use, such as implantable devices requiring training on implantation technique. A supplier of “trained user only” devices will not be permitted to supply such devices to another person unless the supplier provides training on the safe and efficacious use of the devices to every user of the device or ensures users receive such training.
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