Contactless Thermometers in Singapore – the medical device regulations you need to know
COVID 19 has forced us to change the norms of going anywhere and everywhere. Now that temperature screening, mask wearing and social distancing have become a part of life, you might be curious to know more about contactless thermometers or temperature measurement devices and how they are regulated in Singapore.
Contactless Temperature Measuring Devices fall under the definition of medical devices as they are intended for medical purposes and hence have regulations to adhere to. In Singapore, medical devices are classified based on an international rule-based risk classification system. Medical devices are classified into four risk classes – class A to D. Class A is the lowest risk class. This classification depends on various factors such as intended purpose, the user, how it is operated, and the type of technology involved. The risk classification will determine the level of regulatory controls applicable to the medical device.
Contactless Temperature Measurement Devices that are intended to measure and provide body temperature reading to screen for fever. These devices can determine the surface temperature of the skin (e.g., forehead) thereby measuring the person’s body temperature.
As per the guidance document for risk classification, if a non-contact / contactless temperature measurement device can measure and provide a person’s absolute temperature reading, it falls under Class B (low to moderate risk) according to Rule 10(i) of GN-13. However, for a device that only displays an indication (e.g., red colour light, flashing alert) when the person’s temperature exceeds a certain point, it falls under Class A (low risk).
What are the regulatory requirements for Contactless Temperature Measuring Devices in Singapore?
Dealers who wish to manufacture, import, or supply contactless temperature measuring devices are required to possess the applicable medical device dealers’ licenses prior to commencing activity. Companies are required to set up appropriate quality management system based on ISO 13485 or Good Distribution practice for medical devices (GDPMDS) and with the certificate or declaration of compliance apply for the relevant licences.
Dealers of Class A contactless temperature level indication only devices are required to notify HSA of the product via the Class A register. Whereas, dealers of Class B contactless temperature measuring devices are required to submit a product registration prior to the import or supply of the devices.
If you would like to discuss registering your medical device in Singapore please send us an email to [email protected]
For more information on contactless thermometers in Singapore go to the Health Sciences Authority website.