The TGA has published a Guidance document: “Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems” to assist industries of these types of medical devices to comply with new regulations.
The amendments include the reclassification of all surgically invasive medical devices intended to be used in direct contact with the heart, CCS or CNS from Class IIa (low-medium risk) to Class III (high risk), effective from 25 November 2021.
These amendments have come about after the Therapeutic Goods Administration (TGA) conducted a public consultation in order to seek feedback on their plans to align Australian Medical Device Regulations where possible with the European Union Framework.
If an individual is a sponsor of a medical device that is used in direct contact with the heart, CCS or CNS, then they will need to comply with the new regulations depending on their product status:
Medical devices included in the ARTG prior to 25 November 2021- for Class IIa or IIb medical devices included in the ARTG before 25 November 2021 it is permitted these devices are still allowed to be supplied but to supply the device the supplier must notify the TGA before 25 May 2022 that the device will need to be reclassified and the supplier will have to submit an application for the device to be included in the ARTG as a Class III Medical Device before 1 November 2024.
Applications to include a medical device in the ARTG lodged before 25 November 2021- if a supplier has submitted an application for inclusion in the ARTG for a Class IIa device before 25 November 2021 then the application will be assessed and the device will be included in the ARTG as a Class IIa device under the old classification rules. To reclassify the device to a Class III device then the supplier will have to notify the TGA before 25 May 2022 and within 2 months of the start date of the device’s entry into the ARTG, and to also submit an application for the device to be included in the ARTG as a Class III device before 1 November 2024. If the supplier does not notify the TGA before 25 May 2022 or within two months of the start date of the device’s entry into the ARTG then the device will no longer be eligible for transitional arrangements and the supplier must cease supply of the device from 1 November 2024 and cancel the inclusion.
Applications to include a new medical device in the ARTG on or after 25 November 2021- Any application for a new inclusion of a new device that is not already published in the ARTG is to be submitted to the TGA on or after 25 November 2021 and must be submitted as an application for a Class III medical device.
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