Regulatory Background
The TGA states that the outbreak of the pandemic resulted in a significant increase in the number of submissions regarding temperature measuring devices from manufacturers. The present TGA guidance is intended to provide medical device manufacturers and other parties involved with the information necessary to maintain compliance with all requirements medical devices shall meet in order to be eligible to be included in the Australian Register of Therapeutic Goods (ARTG).
Classification of Thermometers
The TGA guidance describes the rules to be applied to determine the proper class of the temperature measuring medical device in question. According to the guidance, the medical device manufacturer shall determine the classification prior to the submission. For this purpose, TGA recommends using a special online classification tool allowing us to define the proper class of the medical device under the classification as prescribed in the Therapeutic Goods (Medical Devices) Regulation 2002.
It is also stated that the final determination of the particular class to be applied depends on the design of the medical device, its intended purpose, and also on the duration of use. In particular, the following rules shall be applied:
- Class I medical devices with measuring functions – all clinical thermometers that do not require power when being used for the intended purpose (e.g. ones containing mercury),
- Class IIa medical devices – all digital thermometers requiring the source of power (battery), including the devices intended for screening and based on the use of an infrared radiation measurement technique.
The TGA warns medical device manufacturers about the importance of correct determination of the class of the device. The authority explicitly states that in the case of incorrect classification, the application for inclusion in the ARTG will be rejected.
Manufacturing Thermometers
As it is stated in the TGA guidance, the medical device manufacturer producing thermometers and other temperature measuring medical devices shall duly maintain compliance with requirements set forth in applicable regulations, namely:
- The Therapeutic Goods Act;
- The Therapeutic Goods (Medical Devices) Regulations 2002;
- The Therapeutic Goods Regulations 1990.
Irrespectively of the class of the medical device under the risk-based classification, the manufacturer shall provide the authority with the information regarding the conformity assessment. According to the document, conformity assessment could be defined as “the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including in vitro diagnostic medical devices) complies with the Essential Principles.”
The Essential Principles the aforementioned definition refers to describe the general safety and performance requirements the medical device shall meet. In particular, they cover the most important aspects related to the design and construction of a medical device.
Thus, medical device manufacturers shall demonstrate that:
- All conformity assessment procedures required under the applicable regulation have been duly performed, and
- All documentation confirming the compliance with the applicable requirements is present and could be provided.
The TGA also states that medical device manufacturers are also allowed to refer to the appropriate international harmonized standards. At the same time, the application of standards is not mandatory – the authority recommends using them in order to simplify the regulatory procedures.
Medical Device Inclusion to the ARTG
The present TGA guidance also describes the procedure to be performed in order to include the thermometer or any other temperature measuring medical device in the ARTG – the national register of medical devices. According to the document, the whole procedure includes the following steps:
- The initial submission of the organization details forms containing the most important information about the applicant. The completed form should be dispatched to the appropriate email address. At this step, the applicant will also receive login credentials needed to access a special portal managed and operated by the TGA to be able to submit further applications.
- Preparing the submission. In particular, the applicant (if it is other than the manufacturer) shall check whether the manufacturer has already carried out the conformity assessment, is able to confirm the compliance with the Essential Principles, establishes an efficient system of post-market surveillance, and also the audit has been duly performed by a conformity assessment body or any other authorized body in the country of residence.
- Submission of the application itself. Any application, including one for thermometers and any other temperature measuring medical devices, should be submitted via the appropriate online portal operated by the TGA (Business Services portal).
- Paying the application fee in accordance with the invoice received. As it is stated in the TGA guidance, the application fee for Class I measuring and Class IIa devices, such as thermometers and other temperature measuring medical devices, is USD 1040. The application will be processed by the authority only upon payment of the appropriate fee.
The TGA also states that the applicant should be an entity duly registered under the laws of Australia. Thus, in the case is the manufacturer of a thermometer or other temperature measuring medical device in question is a foreign entity, an Australian local representative shall be appointed. Such a representative will be responsible for the importation and marketing of the device in Australia.
COVID-related Aspects
The TGA recognizes the importance of certain types of medical devices during the pandemic and intends to implement all the measures reasonably necessary to ensure the uninterrupted availability of thermometers and any other temperature measuring devices on the Australian market in spite of the impact caused by the COVID-related aspects. For this purpose, the TGA grants priority review status for any submissions related to the medical devices intended to be used to address the outbreak of the COVID-19. The authority also states that the applicant does not need to indicate additionally that the medical device in question is vitally important in the context of pandemic and should be subject to expedited review and assessment since the TGA will do this itself.
The authority also reserves a right to contact the applicant and require to provide additional information regarding the thermometer or any temperature measuring medical device submitted to be included to the ARTG, or about the medical device manufacturer, in case if such additional information would be reasonably necessary to assess the application.
Summarizing the information provided hereabove, the new TGA guidance on thermometers and other temperature measuring devices describes the eligibility criteria the device in question shall meet in order to be included in the ARTG, and also the particular procedure to be applied.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
