The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules.
Table of Contents
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reclassification of spinal implantable medical devices. The document provides an overview of the recent changes to the applicable classification rules, as well as additional recommendations and clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
In particular, the document describes the approach to be applied with respect to certain Class IIb medical devices subject to reclassification into Class III and the way the appropriate changes to the entries in the Australian Register of Therapeutic Goods (ARTG) should be introduced.
Device Classification: Class IIb and Class III
The criteria for device inclusion in the ARTG differs between Class IIb and Class III medical devices. For Class IIb devices, an ARTG entry may cover multiple devices if they all:
– Are supplied by the same responsible entity;
– Are manufactured by the same entity;
– Fall under the same classification under the existing risk-based classification rules; and
– Share the same Global Medical Device Nomenclature (GMDN) System Code.
At the same time, Class III devices are determined to be of the same “kind” based on their Unique Product Identifier (UPI).
Submission Timeframes for Class III Inclusion in the ARTG
In accordance with the changes to the classification rules described in the guidance, in order for medical device manufacturers to be allowed to continue distribution of their products after the said changes took effect, reclassification applications to Class III must be submitted before the designated transition period expires. Initially, the last date was slated for July 2023. However, following government recommendations in July 2023, regulatory modifications are currently in progress to extend the transitional period for a few additional years till 1 July 2029.
These changes are anticipated to be finalized by December 2023. The authority additionally emphasizes that in case manufacturers have already submitted the relevant applications prior to the aforementioned date, they can still distribute their devices under the Class IIb ARTG entry, pending a decision on the Class III submission. More details on the regulatory amendment process are provided at the specified TGA website.
Procedure for Reclassification Application
Medical device manufacturers intending to apply for reclassification should follow the below steps:
- Initiate a ‘New Device Application’ on the respective portal;
- Choose “Medical Device – Included” from the provided dropdown list;
- Opt for the “Reclassify an existing register entry”;
- Enter the ARTG Number meant for reclassification;
- Click on the “Clone” button to duplicate the details linked to the ARTG entry; and
- From the dropdown list, select Class III for the “New classification” question.
Should there be any updates regarding the GMDN code in the initial entry, the party responsible for the medical device in question would have to choose the most accurate and up-to-date code from the GMDN database.
The authority additionally emphasizes that in the case a different GMDN code than the one cloned ARTG entry becomes necessary, validation and submission of the application are not possible. In such a case, medical device manufacturers should store the draft application and contact the TGA Devices info line for further guidance. Additionally, if there is a change in the manufacturer, a new application will be required, detailing the existing ARTG entry either directly in the form or as an attached supporting document.
Documentary Requirements
Applications for Class III inclusion in the ARTG require the inclusion of relevant conformity assessment documentation. The specifics of these required documents are provided in the “Documentation to be provided with the application (Evidence of product assessment)” section of Table 2, referencing the use of market authorization evidence from comparable foreign regulating authorities/assessment bodies for medical devices, including the in vitro diagnostic (IVD) ones. This means that in addition to Manufacturer Evidence, the authority also expects the parties responsible for medical devices to provide the necessary product assessment evidence (such as a Design Examination Certificate).
As further explained by the authority, it would also be necessary to provide a brief document that describes the intended use of the device in question and also specifies if the device is used for spinal fusion or motion-preserving in order to streamline the assessment process.
Key Points to Consider
In order to assist medical device manufacturers and other parties involved, the document highlights the following key points to be taken into consideration with respect to reclassification matters:
- It is vitally important for medical device manufacturers to have sufficient time to prepare the conformity assessment documentation, ensuring its submission together with the main application.
- Insufficient conformity assessment documentation means the application will fail to pass the preliminary assessment the authority will carry out. Consequently, the reclassification to the new category will be rejected.
- Class III applications that lack support from MDR, TGA, or AU CAB certification will be subjected to a mandatory application audit. This mandatory audit also includes an audit assessment fee payable by the party responsible for a medical device. Moreover, in the course of such an audit, the authority may request additional information reasonably necessary to assess aspects related to the safety and performance of the device in question.
- As of November 25, 2021, Class IIb spinal implantable devices without the proper MDR, TGA, or AU CAB certification will also be subject to a mandatory audit. These audits could also include an evaluation of clinical evidence.
In summary, the present Tea guidance describes the way the changes should be implemented to existing Class IIb entries in cases where underlying products are subject to reclassification under the new classification rules for spinal implantable medical devices. The guidance also outlines the scope of information the authority expects to receive along with the submission.
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