The new classification rules described in the guidance prescribe that active implantable medical devices should be reclassified from Class AIMD to Class III medical devices. However, the authority also mentions that due to the similar regulatory requirements and evidence required to substantiate the claims regarding the safety and effectiveness of the products when applying for marketing approval, there will be no additional regulatory burden for medical device manufacturers supplying such products in Australia. Apart from that, special transitional arrangements are introduced in order to prevent shortages and ensure the availability of medical devices already placed on the market. The parties involved in the supply of such products would have to notify the TGA accordingly by completing an online form which was available until 24 May 2022. Such a notification should include, inter alia, the respective number under which a medical device in question is included in the Australian Register of Therapeutic Goods (ARTG), as well as UPIs for each of the products involved.
Class III Applications for ARTG Inclusion
According to the guidance, in order to be allowed to continue offering its products, the manufacturers of AIMDs shall submit the appropriate application before 1 November 2024. It is also stated that once the application is submitted, the products could be still marketed even if the authority hasn’t decided with respect to the application. Such an application should be submitted in the electronic format through the respective online services portal operated by the authority. The authority additionally emphasizes that applications submitted in any other form would not be accepted.
When submitting an application, the applicant will have to indicate the applicable GMDN code. Should the code initially used for the product be no longer available, the most appropriate one should be used.
Once the application is submitted, it will have to pass a preliminary assessment conducted by the authority in order to ensure all the necessary elements are present. In order to pass this assessment, the applicant should ensure all the information and evidence required are included in the submission. Should the application fail to pass the preliminary assessment, it will be refused, and the device in question will not be transitioned to the new classification category. With respect to the application review, the authority also mentions that Class III applications for ARTG inclusion to reclassify active implantable devices will not be subject to mandatory audit, however, TGA will select applications for non-mandatory audit if there are any concerns with the application (e.g., post-market signals) or if there are minor changes in the submitted reclassification application. For instance, the authority may decide to pay additional attention to the application, should it be identified that the information provided in it is not consistent with the one reflected in the current entry. Furthermore, it is also stated that in case of changes to the medical device manufacturer, a new application will be required.
Fees and Charges
The scope of the guidance also covers the aspects related to the fees and charges payable in the context of applications described therein. For instance, it is stated that for the applications submitted during the first year of the transition period the fees would not be charged. At the same time, all the applications submitted starting from the second year and till the end of the period would be subject to fees payable by the applicants. Should the product in question be included in the register as a Class III medical device, the appropriate annual fee will apply. At the same time, in case of reclassification, there will be no need to pay an additional fee for the same period.
As it is mentioned in the guidance, in case of a negative decision taken by the authority with respect to the application submitted, the applicant will be notified in writing, and the appropriate justification will be provided. Should the applicant disagree with the decision taken, it may apply for reconsideration of the decision. The appropriate request should be submitted within 90 days from the date the initial decision was taken. The reconsidered decision could further be objected to in the Administrative Appeals Tribunal.
Furthermore, the authority additionally emphasizes that should the party responsible for a medical device subject to reclassification fail to fulfill its obligations under the transitional regime and comply with the respective requirements, it should cease supply of the device in question. Under the general rule, if no application is submitted before 1 November 2024, the supply should be ceased from this date. Should the application for reclassification be rejected by the authority, the supply should be ceased from the date of the appropriate decision taken by the authority.
In summary, the present guidance document describes in detail the new reclassification rules, as well as the transitional regime introduced in order to prevent shortages in supply and the continuous availability of medical devices already placed on the market. The authority outlines the steps to be taken by the parties responsible for medical devices in order to be allowed to offer their products once the transitional period expires.
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