The Therapeutic Goods Administration (TGA) of Australia has published a notice describing the approach to delays in medical device conformity assessment recertification. The document is intended to address the issues related to the outbreak of COVID-19 caused by the virus SARS-CoV-2 or the “novel coronavirus,” and also the delay in the actual implementation of the new EU-wide regulatory framework, the Medical Device Regulation 2017/745 (MDR), announced earlier in 2020.
Regulatory Background
Due to the recent changes in the medical devices regulation and also the impact of COVID-related factors and travel restrictions associated thereto, the manufacturers have faced certain difficulties with sustaining compliance with the applicable requirements in general and maintaining the validity of the documents submitted to the Australian Register of Therapeutic Goods (ARTG, the country’s national register for healthcare products) in particular.
As it is stated in the document, under the Australian legislation, medical devices included in the ARTG must have the appropriate conformity assessment procedures applied to the medical device, and sponsors must ensure the manufacturer holds the appropriate conformity assessment document for their devices.
The present guidance is intended to provide the sponsors and medical device manufacturers with additional information about the approach introduced by the regulating authority with regard to the expiration of the validity term for the conformity assessment documents resulting from the delays in audits caused by the pandemic-related factors. The document also addresses the issues arising from the insufficient number of notified bodies already designated to carry out conformity assessment under the MDR. The scope of the guidance covers both Australian and foreign documents related to the medical devices marketed in Australia. At the same time, in certain cases, the documents should be treated differently depending on the country of origin.
The TGA additionally emphasizes that the present guidance does not substitute any applicable laws and regulations, but only provides the current thinking of the authority and additional recommendations to be considered by all the parties involved. Moreover, the document could be subject to changes reasonably necessary to address the changing situation.
Core Terminology
First of all, the authority provides the definitions of the key terms used in the context of conformity assessment, namely:
- A conformity assessment document (CAD) – a reference to a certificate issued by the TGA, an Australian conformity assessment body certificate, or an overseas comparable regulator conformity assessment document,
- A conformity assessment certificate (CAC) – a reference to a certificate issued by the TGA under s. 41EE of the Therapeutic Goods Act 1989,
- An overseas regulator conformity assessment document (ORCAD): certificate or other evidence of conformity assessment issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of that device.
Conformity Assessment Document Expiration (Lapse)
The TGA uses the term «lapsed» with regard to the conformity assessment document that has expired only since the time has passed, and not as the result of regulatory action. According to the guidance, in such a case, there should be no automatic cancellation of an entry in the ARTG associated with the medical device. When assessing the case and determining further actions to be taken, the regulating authority would take into consideration the attempts of the sponsor to address the issue. In particular, the TGA would pay attention to the following:
- the actions were taken by the sponsor of the device in order to find a solution (e.g. contacting the medical device manufacturer regarding the extension or renewal of the documents in question);
- the timeliness of the steps performed by the sponsor (e.g. whether such steps have been taken in advance);
- the effectiveness of communications between the sponsor and the authority (in particular, the TGA expects the sponsor and/or the manufacturer to inform proactively about the actions to be taken in order to sustain compliance with the applicable requirements and the validity of the conformity assessment documents);
- whether the sponsor has provided the authority with sufficient information demonstrating that any and all necessary conformity assessment procedures have been duly performed,
- the actual reasons due to which the current conformity assessment document is absent (e.g. whether it has expired due to the impact of COVID-related factors or it was suspended, canceled, or revoked by the regulating authority).
Thus, the sponsor shall provide the TGA with sufficient information demonstrating that all reasonable actions have been taken to maintain the validity of the conformity assessment documents, otherwise the authority is entitled to suspend or cancel the appropriate entries in the ARTG resulting in the prohibition of further marketing of the device in Australia. The TGA also emphasizes that in case if the conformity assessment document has been suspended or canceled due to the compliance issues on the part of the medical device manufacturer, the authority would have to cancel the ARTG entry associated with the device as prescribed by the applicable legislation.
Steps to be taken by the Sponsors
In order to assist the sponsors with sustaining compliance with the applicable requirements, and also to ensure the availability of medical devices on the market and prevent shortages in supply, the TGA provides certain recommendations regarding the actions in case of risks associated with the lapse of the conformity assessment documents.
First of all, the sponsors shall duly notify the TGA about:
- The upcoming expiration of the conformity assessment documents. Such a notification should also contain information about the planned steps to be taken by the sponsor.
- The upcoming expiration of conformity assessment certificate (no later than in 6 months prior to the expiration),
- The reasons for the lapse and the actions taken – in case if the conformity assessment documents have already lapsed.
The authority also mentions that the failure of the sponsor to inform the TGA in a way described hereabove would be also taken into consideration when determining the further regulatory actions, including the suspension or cancellation of the appropriate entry in the ARTG. Thus, the sponsors (and, in certain cases, medical device manufacturers) are recommended to notify properly the authority about the situation that could potentially result in expiration or lapse of the conformity assessment documents, and also to take timely actions to prevent such a lapse, otherwise, they would be prohibited from marketing their medical devices in Australia.
Summarizing the information provided here above, the present TGA guidance describes the way the authority would treat the expiration of the conformity assessment documents caused the COVID-related factors or the situation with the insufficient number of notified bodies designated to perform conformity assessment under the Medical Devices Regulation 2017/745. The document also outlines the particular steps to be taken by the sponsors and medical device manufacturers to maintain the validity of the current conformity assessment documents and certificates in order to avoid the suspension or cancellation of the entry in the ARTG.
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