And out they go…BREXIT is final! But what about Australia?
After several years of leadership changes, elections and conspiracies, we’ve finally arrived at the exit gate. Effectively, with no deal being reached, the implications to the UK are significant, however the impact to the Medical Device Industry is yet to be fully understood.
Throughout 2019, the team at Brandwood CKC have been busily researching the necessary changes that are likely to occur once the final decision is made. This is evident through the number of articles we’ve prepared.
One of the highest read articles throughout the year was How a No Deal Brexit may Jeopardise Medical Device Supply in Australia. The article went into depth around the legal requirements ensuring your ability to continue supply of Medical Devices into the Australian market. Specifically, the regulatory situation can be complicated. There are two requirements for the legal supply of a medical device in Australia:
- the device must be included in the Australian Register of Therapeutic Goods (ARTG); and
- the supplier must have evidence of compliance with safety requirements.
It’s estimated for over 90% of entries on the register supplied in Australia, compliance evidence is a CE certificate.
In the article, we go further to outline some of the potential pathways the Australian regulator may provide, however the TGA has not stated publicly how it will react. There are several possibilities including:
- TGA may simply exercise administrative discretion to not enforce the import requirements to give suppliers some period of grace to make alternate arrangements.
- The Health Minister may formally intervene to exercise emergency powers. The Therapeutic Goods Act provides for the Minister to grant exemptions from regulatory requirements (including holding Conformity Assessment Certificates) in case of national emergency. These powers are intended to allow rapid responses to situations such as pandemics. But in theory, they could be applied to a no-deal Brexit “emergency”. For example, it would theoretically be possible for the Minister to temporarily waive requirements for current certification for the class of devices previously certified by one of the UK Notified Bodies. However, this then creates a whole range of additional administrative overload on suppliers who must track every device supplied under the exemptions and provide reports on their distribution.
- TGA could declare that it continues to recognise the British Notified Bodies as competent assessors (even though Europe will have ceased to do so.
So where did we end up?
In an article published by the Australian regulator in November, Brexit – Implications for therapeutic goods in Australia, the TGA attempts to provide some understanding for manufacturers as to what the transition may look like and how they anticipate managing the Brexit situation.
This includes the acceptance of UK Notified Bodies for new and existing products on the condition the products are manufactured under the existing MDD framework and prior to the associated expiry dates up until the date of the exit.
- Medical devices currently included in ARTG may continue to be imported and/or supplied in Australia with the current certification issued by UK notified bodies, which are subject to continuing MHRA oversight.
- Two instruments will be amended to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies:
- The Therapeutic Goods (Overseas Regulators) Determination 2018 will be amended to include recognition of notified bodies granted ongoing legal status by the MHRA.
- The Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination 2018 will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG.
It must be noted that as we close into the final hours, the above changes are still to be finalised.
In most instances, manufacturers with a NB in the UK are looking to transfer their existing CE certificates from the UK to a EU notified body. In this instance, it’s important for manufacturers to update their ARTG entries, and associated certificates.
In circumstances that you’ve relied on European approvals to gain access to the Australian market, or any other market and you’re not intending to continue with your European approvals, there are other ways.
For example, in 2018 the Australian regulator opened the door to accepting other international approvals. This includes US FDA, Canadian and Japanese approvals.
So, all is not lost!
Regulators around the world are seeing the implications caused by not only Brexit, but the incoming Medical Device Regulations (MDR), and they’re beginning to consider alternate pathways for companies to still bring new innovative technology to market.
If any of this article applies to you, be sure to reach out to us for a free, no obligation discussion on how you might navigate such a situation.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
The views and options expressed in this article are those of the author/s and do not necessarily reflect the views of Brandwood CKC Pty Ltd ACN 128 762 505.
The information presented in this article is of a general nature only and does not consider the particular circumstances of your business. Prior results and case studies do not guarantee a similar outcome in future. You should not rely on this information, and you should seek specific advice for your particular business needs.
Where indicated, certain content has been sourced from third parties; we have not independently verified it. Neither Brandwood CKC nor the author makes any warranty as to the accuracy, completeness or reliability of this article, nor do those parties accept any liability or responsibility arising in any way from omissions or errors contained in the content.