HSA Singapore recently released a statement regarding non-contact or contactless thermometers. HSA informs the public and stakeholders of its use and how the authority regulates this product in the country.
Non–contact or contactless thermometers intends to provide a reading on a person’s body temperature for fever screening. These devices do not come into contact with the skin of the person and by just reading the surface temperature (skin).
HSA Singapore categorizes devices via risk classification, from Class A (low risk) to Class D (high risk). This is elaborated further in the guidance document GN-13: Guidance on the Risk Classification of General Medical Devices. Various factors such as intended use, how it operates, the user, type of technology involved, etc., are considered when classifying such devices. The higher the risk class, the stricter the regulatory controls are. With contactless thermometers, the following risk class is followed:
- Class B: Non–contact or contactless thermometers that can provide absolute temperature reading can be provided,
- Class A: Non–contact or contactless thermometers that only displays indications or signs (e.g., color light, flashing alert) when reading exceeds a certain threshold. The reading will be then confirmed by a regular thermometer.
Dealers that aim to manufacture, import, or supply such medical devices need to secure medical device dealer’s licenses prior to executing such. The complete requirements can be found in the guidance document GN-02 Guidance on Licensing of Manufacturers, Importers, and Wholesalers of MD. For Class A thermometers, dealers are required to notify HSA via MEDICS. For Class B thermometers, product registration must be submitted prior to the execution of dealer-related activities.
HSA reminds end users to understand the operation manual or instructions for use (IFU) of the thermometers prior to using such devices. The authority states that the ambient temperature of operation plays a key role in the proper functioning and accuracy of the device’s output. In addition, recommended settings must be observed when using these devices.