TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

Author: Luis Jimenez

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response to the shortage on notified bodies ready to perform MDR and IVDR certifications, the travel bans preventing on-site audits and the current Covid-19 pandemic.

The guidance stipulates that:

“Where a Conformity Assessment Documents (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 ARTG. The TGA will consider, in deciding whether suspension or cancellation of a device entry is warranted, whether the sponsor has taken reasonable steps to mitigate the problem.”

Although the guidance does not specify exactly for how long the TGA may extend the ARTG lifetime, it provides the criteria under which extensions will be evaluated.

Who does this impact?

Conformity Assessment Document refers to the underlying evidence of an overseas regulator approval that the manufacturer has used for an Australian ARTG. This usually refers to a CE Mark or in the case of MDSAP-holding companies US approvals, Health Canada Approval and/or Japanese approval. If you are having challenges renewing your Conformity Assessment Documents, you need to reach out to the TGA to ensure they are aware of the situation.

It also applies to companies that were required to have a review by the TGA prior to approval. This includes all products registered in Australia that are class III, active implantable medical devices (AIMDs) and all products containing tissues, cells or substances of microbial or recombinant origin. Again, in order to prevent interruption of supply communication with the TGA about this is critical.

What about novel technologies or new market entrants?

Unfortunately, this guidance or associated exemption does not apply to companies that have been negatively affected by delays in getting their first conformity assessment certificate due to the delays on MDR implementation of the Covid-19 Pandemic. In other words, it only applies to companies that already have had a conformity assessment.

What about companies that have not been able to secure the proper MDR CE Marks and whose MDD CE Mark holding has expired?

While working closely with the TGA and not having any regulatory action associated with your products is the key, this guidance provides a possible pathway to allow companies who have an expired MDD certificate and have been actively trying to get in the queue for MDR or a renewal under MDD eligible for continued market access in Australia.

Evaluation Criteria for the TGA not cancelling the Conformity Assessment Certificates

The TGA’s guidance specified that it will take into account the following six (6) factors in determining if the manufacturer will be able to continue to supply products to Australia in the case of a lapse in Conformity Assessments.

1. The steps which the sponsor has taken to mitigate the situation
2. Timeliness of the sponsor’s actions
3. The extent to which the sponsor has kept the TGA informed
4. Whether the sponsor in the absence of a CAD has provided information to the TGA to substantiate that the devices have had the conformity assessment procedures, or requirements comparable to the conformity assessment procedures, to the satisfaction of an overseas regulator, applied to them
5. the presence or absence of other reasons for the lack of a current CAD

The TGA urges sponsors and manufacturers to reach out to the TGA promptly:

• if their Conformity Assessment Documents (CAD)s are pending expiry and there may be issues with obtaining extensions or new CADs, outlining what steps they are taking to address the problem;
• in the case of a TGA issues Conformity Assessment Certificate (CAC): submitting an extension application to the TGA at least six months prior to the expiry of the current CAC; or
• if their CADs have already lapsed, the reasons for the lapse, and what action they are taking to address this issue.

Sponsors (or if relevant, manufacturers) should notify the Devices Post Market Reforms and Reviews Section of the above matters, together with relevant supporting documents, at postmarketdevices@health.gov.au

“The TGA will take failure to inform it promptly of the above matters into account when deciding whether device entries should be suspended or cancelled.”

As the compounding challenges of MDR and IVDR transitions, shortages of reviewers/notified bodies, travel bans and the covid-19 pandemic continue to unfold; open and transparent communication with regulators is more critical than ever.

If you have questions about how to engage with regulatory bodies such as TGA, please reach out to us to explore how we can assist in navigating both the regulatory changes, but also the required communications with regulatory agencies.

References

The TGA’s approach to delays in medical device conformity assessment recertification
https://www.tga.gov.au/resource/tgas-approach-delays-medical-device-conformity-assessment-recertification

Therapeutic Goods (Medical Devices) Regulations 2002. Conformity Assessment Procedures (Compilation Date: 25 August 2020)
https://www.legislation.gov.au/Details/F2020C00822