The COVID-19 pandemic urged an immediate rise in the supply and demand of thermometers. Proposedly, the sponsors and manufacturers applied to Therapeutic Goods Administration (TGA) for the inclusion of thermometers in the Australian Register of Therapeutic Goods (ARTG). Based on the significant number of applications received, the TGA devised guidelines to support the manufacturers and the sponsors both in terms of meeting the relevant Regulatory obligations and submitting the applications for a thermometer and to include them in the ARTG.
TGA Thermometer Classification
Generally, thermometers are classified as Class I (measuring) and Class IIa devices. Clinical thermometers, like, glass and mercury and not battery operated are regulated as Class I and the battery-powered digital thermometers, like, infrared/electronic are regulated as Class IIa devices.
The device classification can be determined, using an online classification tool. If the application does not hold appropriate device classification, it cannot go through the preliminary assessment. All classes of medical devices should meet the conformity assessment procedures and comply with the essential principles (device design & construction) prior to manufacturing.
Thermometer ARTG Inclusion
After meeting the above criteria, the device can be included in the ARTG and further imported or supplied within Australia. But through a certain set procedure and Regulatory obligations. Applicants can follow the below points step-by-step.
- Complete the organizational details form and submit to eBS@health.gov.au.
- Upon receiving username and password, one can submit applications for the inclusion of devices in the ARTG
- Ensure the device manufacturer has applied an appropriate conformity assessment procedure to the device, has evident documentation of device complying to essential principles, has a system for post-market monitoring & taking corrective action in place and has been audited by a conformity assessment body or comparable overseas regulator
- Log into the TGA Business Services online portal and submit a Manufacturer's Evidence application
- Post receiving the MEA acceptance notification from the TGA, log into the TGA Business Services online portal and submit an application for your device to be included in the ARTG
- Upon receiving an invoice, pay the application fee through the TGA Business Services portal. The TGA will commence processing your application after the payment.
During these times of health emergency, every sponsor and the manufacturer of thermometer should strictly adhere to the recommended regulations for expedited review and approvals. Thus, the device can be released into the market quickly supporting the requirement of healthcare professionals. Aim for the compliant market entry with on-time Regulatory assistance. Stay safe. Stay informed. Stay compliant.