How a No Deal Brexit may Jeopardise Medical Device Supply in Australia
This is not just a political temper tantrum in a small Island somewhere off the coast of France. Brexit will have global implications: including some strange effects in markets far from Europe. One particular example is disruption of legal supply of medical technology in Australia.
In Australia, more than 90% of the medical equipment is approved for supply based on a European CE certificate. Australia relies heavily on imported medical technology. And most of these devices have already been assessed in Europe. Australia’s regulator the Therapeutic Goods Administration (TGA) operates under regulations closely modelled on European rules, so, for most devices, TGA recognises CE certification as an acceptable alternative to its own assessment.
And a goodly proportion of those devices were certified by four by British Notified Bodies: BSi Healthcare (UK), LRQA, SGS (UK) and UL International (UK).
But with a no-deal Brexit becoming a distinct possibility, there is a clear and present danger that all of these UK based certifications will become invalid the moment the UK crashes out of the EU at the end of March 2019.
So where does that leave all those devices in Australia?
Requirements for Legal Supply
The regulatory situation is a tricky one. 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.
For most devices supplied in Australia that compliance evidence is a CE certificate (A Conformity Assessment Certificate in TGA parlance).
Standing on One Leg?
ARTG Inclusion won’t be an immediate problem. An ARTG registration is based on the evidence provided at the time of application and the registration remains valid until cancelled either voluntarily by the supplier or by TGA action. And it takes a lot of time and effort for TGA to force a cancellation with many avenues for appeal. So the devices will remain included in the ARTG.
However, the requirement for “manufacturer’s evidence is much more problematic. Any manufacturer holding a UK issued CE certificate will be left without formal evidence of compliance come March. So suppliers are effectively left standing on one leg…
It is a criminal offence under the Therapeutic Goods Act to knowingly import a device into Australia without holding such evidence. So in theory, anybody importing a medical device certified by a UK Notified Body would be committing a crime if they continued to do so after a no-deal Brexit. Punishment ranges from fines to up to 12 months jail time. If the device causes an injury, that increases to up to 5 years.
Now I am not suggesting for a moment that The Australian Federal Government is about to launch mass prosecutions of device suppliers. TGA is generally pragmatic and understanding and would be expected to show as much flexibility as possible.
So what may TGA do?
TGA has not stated publicly how it will react. There are a number of 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 have to 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.
In Emergencies – Queues
It’s all very messy. What is clear is that any manufacturer still holding CE certification from a UK Notified Body without advanced plans for shifting to a European alternative is in real difficulties and with the current transition to the Medical Device Regulations distracting all of the Notified Bodies, the queues for reassessments are very long and the time taken to do so very long.
Another avenue is for manufacturers to switch to rely on certifications from other jurisdictions. TGA recently expanded its acceptance of international assessments to include the US, Canada and Japan. But that’s a new process and not likely to be suited to emergency use.
Finally, Australia is not alone in accepting CE certification to grant local licenses. This is done by many other jurisdictions including many in the Asia Pacific Region. Singapore, Malaysia, Taiwan are examples. The ramifications of Brexit will reach around the Globe.
We offer deep support for manufacturers navigating Australia. Our expert consultants are skilled in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)