Non-contact/ Contactless Temperature Measurement Devices
What are non-contact/ contactless temperature measurement devices?
Non-contact/ Contactless Temperature Measurement Devices refer to equipment or devices that are intended to measure and provide body temperature reading for fever screening. These devices are able to detect and determine the surface temperature of the skin (e.g. forehead) of an individual and compute the body temperature of the individual.
How are they regulated in Singapore?
Non-contact/ Contactless Temperature Measurement Devices are intended for medical purposes i.e. to identify individuals with fever and are regulated as medical devices under the Health Sciences Authority (HSA).
In Singapore, we adopt an international rule based risk classification system for medical devices. Medical devices are classified into four risk classes – class A to D, with class A being the lowest risk class. This classification considers various factors such as the intended purpose of the medical device, how it operates, the user, and the type of technology involved. The regulatory controls are proportional to the risk classification of the medical device.
With reference to GN-13: Guidance on the Risk Classification of General Medical Devices, if a non-contact/ contactless temperature measurement device is able to measure and provide an individual’s absolute temperature reading, it is classified as Class B (low to moderate risk) medical device according to Rule 10(i) of GN-13. However, for a device that does not provide absolute temperature readings but only displays an indication (e.g. red colour light, flashing alert) when temperature exceeds a certain cut-off, it will be classified as Class A (low risk). For such a Class A device, the absolute temperature of the individual will have to be measured using a thermometer to determine fever.
What are the regulatory requirements for medical devices?
Dealers who wish to manufacture, import or supply medical devices are required to possess the applicable medical device dealers’ licenses prior to the commencement of the activity(s). The 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.
Please refer to GN-02 at https://www.hsa.gov.sg/medical-devices/guidance-documents more information on the dealers licenses’ requirements.
Additionally, dealers dealing with Class A medical devices are required to notify HSA of the product via the Class A database. The Class A database is accessible at https://www.hsa.gov.sg/e-services/medics
On the other hand, dealers dealing with Class B medical devices are required to submit a product registration prior to the import or supply of the devices. Upon approval of the application, dealers may then proceed with the import or supply of the devices. Any Singapore-based companies registered with ACRA may apply for product registration. Please refer to GN-15 at https://www.hsa.gov.sg/medical-devices/guidance-documents more information on medical devices product registration.
For more information on product registration and licensing of dealers process and requirements, please refer to our Quick Guide available at: http://www.hsa.gov.sg/medical-devices/regulatory-overview.
Proper use of Non-contact/ Contactless Temperature Measurement Devices
Prior to the use of such devices, users should ensure that they understand all instructions in the operation manual or Instructions for Use (IFU) accompanying the device. The environmental temperature in which the device will be operating at, plays an important role in the proper functioning and accuracy of the device. Ensure that the device is operated under the recommended settings per the operation manual.