TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID
Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.“[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due to COVID-19 and the limitations on the current number of notified bodies designated under [MDR],” TGA writes.
TGA notes that the guidance applies to both international and Australian conformity assessment documents (CADs).
“Where a CAD has lapsed (that is, has expired solely because of passage of time and not because of regulatory action), this will not result in automatic cancellation of a device entry in the [Australian Register of Therapeutic Goods] ARTG,” TGA explains.
Instead, TGA says its decisions on whether to suspend or cancel the entry of a device will be informed by the steps taken by the device’s sponsor and the timeliness of the sponsor’s actions. Such efforts could include verifying whether the sponsor’s manufacturer is seeking an extension or renewal of their CAD or seeking permission from the relevant overseas regulator to continue manufacturing pending renewal of a CAD.
TGA also says it will consider the extent to which the sponsor has kept it informed of the process. “For example, informing the TGA promptly of the pending expiry of CADs, and of the proposed actions by the manufacturer and/or the sponsor, together with relevant supporting evidence (e.g. correspondence between the manufacturer and the sponsor).”
However, for CADs that have been “suspended, cancelled, revoked or otherwise terminated due to noncompliance issues on the part of the manufacturer, the TGA will apply the terms of the [Therapeutic Goods Act].”
TGA recommends that sponsors whose CADs may expire or have already lapsed notify it promptly and explain the steps they are taking to address the issue. For manufacturers with an Australian conformity assessment certificate, TGA recommends submitting an extension application at least six months before the current one expires.
TGA