The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical devices and placing them on the market with additional clarifications on the applicable regulatory requirements and also the recommendations to be considered. However, the provisions of the document are non-binding in their legal nature, so in the case of any discrepancies with the applicable provisions of the current legislation, the latter shall prevail. Additionally, the TGA reserves the right to amend the guidance from time to time in order to reflect changes that occur to the regulatory framework.
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 medical devices in direct contact with the heart, central circulatory, and central nervous systems. The document provides additional clarifications regarding the changes to applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Recommendations provided in the guidance could also be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The document supplements a set of guidance documents issued by the TGA to describe the transitional arrangements and obligations of the parties responsible for medical devices to be followed in order to be able to continue supplying their products on the Australian market.
First of all, the authority states that from 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
The initial public consultations dedicated to the changes proposed were conducted earlier in 2019 when the authority announced its intent to align the national regulatory regime with the EU framework. The changes provide reclassification of medical devices in question from Class IIa (low-medium risk) to Class III (high risk).
Requirements for Reclassification
As further described by the TGA, the requirements include:
- More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device;
- Conformity assessment documents demonstrating procedures appropriate for a Class III device;
- Mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
In accordance with the changes to the classification rules, any and all devices in direct contact with the heart, CCS or CNS shall be reclassified to Class III irrespective of the duration of action. Hence, the products intended for transient or short-term use should also be reclassified from Class IIa (low-medium risk) to Class III (high risk), while the ones intended for long-term use are already classified as Class III, consequently, there will be no changes for such products.
The guidance also provides several examples of medical devices subject to reclassification. According to the document they include, inter alia, the following ones:
- Self-expanding valve prosthesis;
- Post-dilatation balloon catheter;
- Caridac vent catheter;
- Central venous catheterization kit;
- Cardiopulmonary cannulae;
- Rigid neuroscope;
- Spinal needle.
In order to assist medical device manufacturers and other parties involved in operations with medical devices subject to reclassification, the authority outlines the actions to be taken in order to be allowed to continue supplying such products during the transitional period and after its expiration. The particular actions to be taken will depend on the current regulatory status of the product.
- In the case of medical devices already included in the Australian Register of Therapeutic Goods (ARTG) prior to 25 November 2021, the appropriate notification should be submitted to the authority, and then followed by the respective application for inclusion in the register under the new classification rules. Should a party responsible for a medical device subject to reclassification decide to cease the supply, the inclusion in the register should be canceled by the virtue of a notification to be submitted.
- In the case the application for inclusion in the register under old classification rules has already been submitted, the process will be finalized as is, and the device will be included in the register as a Class IIa product. In order to ensure compliance with the new requirements, a party responsible for the device should notify the authority no later than 2 months from the date the registration was completed, and then apply for inclusion under the new regimes. Should the party responsible for a medical device fail to complete the said steps, it would be no longer allowed to supply the device in question, while the inclusion should be canceled.
- All new applications for inclusion in the ARTG should be submitted in accordance with the rules and requirements applicable to Class III medical devices. In this respect, the authority refers to the respective guidance documents dedicated to the ARTG inclusion process in general, as well as the ones describing differences between Class IIa and Class III products and requirements applicable thereto.
Apart from the general principles described hereabove, the guidance also highlights additional key points to be taken into consideration by the parties responsible for medical devices subject to reclassification. For instance, the authority mentions that all the notifications mentioned in the guidance should be conducted in an electronic format using the respective online form. When submitting such notification, the party responsible for a medical device will have to indicate the ARTG number and other details necessary to identify the device.
The TGA also emphasizes the important difference between the requirements for Class IIa and Class III products and applications associated thereto. Under the general rule, in order to be eligible for inclusion under one ARTG entry, medical devices should be of the same kind. According to the guidance, in order to be considered to be of the same kind, Class IIa medical devices should have the same sponsor, manufacturer, classification, and Global Medical Device Nomenclature (GMDN) System Code. At the same time, in order for Class III medical devices to be considered to be of the same kind, they should also have the same Unique Product Identifier (UPI).
In summary, the present TGA guidance describes in detail the new classification rules to be applied with respect to medical devices intended to be in direct contact with the heart, CCS, and CNS. The document also outlines the steps to be taken by the parties responsible for such devices to be allowed to supply the said products under the new framework.
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