The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for healthcare products, has published a guidance document describing transitional rules on reclassification of active implantable medical devices (AIMD). The regulatory changes addressed in the document are part of the general reclassification of medical devices announced by the TGA.
Earlier, the authority issued separate guidance describing aspects related to the reclassification of medical devices used to administer medicines.
The present document constitutes the initial version of the guidance. The authority also states that guidance documents are intended to provide additional clarifications and recommendations to be considered by the medical device manufacturers and other parties involved. They do not introduce new rules and requirements themselves. In the case of any discrepancies with the provisions of existing legislation, the latter should prevail. The authority encourages interested parties to familiarize themselves with the main regulations and ask for additional legal advice when necessary. The TGA also reserves the right to amend the present guidance and recommendations provided therein if necessary to reflect changes with the applicable laws and regulations.
The main point of the guidance is that starting from November 25, 2021, active implantable medical devices will be required to be reclassified from Class AIMD to Class III.
Public consultations on the reclassification of certain medical devices, including active implantable devices, were carried out by the regulating authority earlier in 2017. The primary purpose of the suggested changes is to reflect amendments to the applicable regulations for medical devices intended to harmonize the regulatory approach with the one utilized in the EU. The TGA further describes that while the general idea to align Australian medical device regulations with the provisions of the EU regulations was widely accepted by stakeholders, the positions expressed concerning the suggested reclassification of accessories to active implantable medical devices differed. However, as is explicitly mentioned by the TGA, the regulatory requirements for Class III medical devices are exactly the same as the ones applied for Class AIMD products. Hence the parties involved would not face additional regulatory burden when the new classification would take effect.
According to the applicable legislation, active implantable medical devices are intended:
- To be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
- To be, by medical intervention, introduced into a natural orifice in the body of a human being; and
- To remain in place after the procedure.
The document provides some examples of active implantable medical devices subject to reclassification, such as implantable cardiac pacemakers, implantable cardiac monitors, or brain electrical stimulation systems.
Actions to be Taken
The document further describes actions to be taken by the responsible parties regarding medical devices falling within the scope of reclassification in order to achieve and sustain compliance with the applicable regulatory requirements. These actions depend on the current regulatory status of the medical device in question in terms of the date of inclusion in the Australian Register of Therapeutic Goods (ARTG).
According to the applicable legislation, any and all medical devices intended to be marketed in Australia should be included in the ARTG unless they are subject to special exemption rules. In particular, the present TGA guidance prescribes the following approaches:
- For active implantable medical devices included in the register before the new classification takes effect transitional regime framework will apply. According to the transitional regime rules, the responsible entity shall notify the regulating authority about the medical device subject to reclassification before May 25, 2022, and then apply for inclusion in the register under the Class III medical device framework before November 1, 2024. If the responsible entity intends to suspend the supply, the appropriate notice also should be provided before May 25, 2022. Should the responsible entity fail to apply for inclusion of its product in the register as a Class III medical device prior to the date indicated above, the supply of the active implantable medical device should be suspended.
- In the case of active implantable medical devices for which there is an active application for inclusion in the register under the new Class AIMD framework duly submitted before November 25, 2021, such an application will be subject to review under the existing regulatory framework. Thus, the responsible entity will have to notify the regulating authority about the medical device requiring reclassification before May 25, 2022, or within 2 months from the date the device in question was initially included in the register. The appropriate application for inclusion in the register under the new classification rule should be submitted before November 1, 2024. Should the responsible entity fail to meet the requirements described herein, further marketing of the device would be prohibited.
- In case of new applications for inclusion in the register that will be submitted on or after November 25, 2021, the new approach should be applied. Thus, starting from the aforementioned date, all new applications for the inclusion of active implantable medical devices in the ARTG should comply with the requirements for Class III medical devices.
In order to notify the regulating authority about the active implantable medical device that is subject to reclassification, a responsible entity shall use the appropriate online form, which will be available until May 24, 2020. When submitting an application, a responsible entity shall also indicate the current ARTG number assigned to the medical device in question, as well as UPIs.
Class III Applications for ARTG Inclusion
Apart from the general requirements and transitional regime rules to be applied for existing medical devices already placed on the market or those for which the applications for inclusion have been already submitted, the present TGA guidance also describes the particular requirements the applications for inclusion of an active implantable medical device should meet under the new framework. Such an application should be submitted before November 1, 2024, in order for the device to be allowed for marketing and use thereafter. The authority also mentions that if the responsible entity receives no response regarding its application submitted prior to that date, it will be allowed to continue the supply of a medical device until such a response is received. The application should be submitted in electronic form and should be accompanied by the supporting documentation together with the manufacturer evidence. Once received, the application will be subject to preliminary assessment, during which the authority will assess the completeness of the application. The applications that fail to pass such an assessment will be rejected.
In summary, the present TGA guidance describes the new regulatory approach for active implantable medical devices to be introduced in Australia from November 25, 2021. The document also outlines the particular steps to be taken by responsible entities to achieve and sustain compliance with the new rules to be allowed to supply their products on the market.
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