Senate Community Affairs Legislation Committee [Part 2], , 3:53:31 to 4:03:02
The TGA explains its risk-based approach to medical device regulation, including the use of conformity assessments and reliance on overseas regulatory decisions.
Topics: Health, International law
Speakers: Tracey Duffy, Speaker 29, Prof Anthony Lawler, Dr Marcelle Noja, John Jamieson, Speaker 30
>> Thank you, Chair. >> An investigation by the age found that the TGA assessed applications for 50 Oh, sorry. I should have said in case there needs to be a change of panel. It's um medical device regulation. Restart the clock. >> It's getting late.
>> Yeah. So that's what that's what the exemptions done. >> So the exemption is long.
>> Thank you very much. An investigation by the age found that the TGA assessed applications for 55,223 Divi medical devices in the last decade. So from 2016 to 2026 in that time only 4.3% of applications were subject to a conformity assessment and only 830 devices were rejected. Is that an appropriate or uh representative percentage of devices to subject to conformity assessments?
I can start. Thank you. Senator Tracy Duffy, First Assistant Secretary, Medical Devices and Product Quality Division. Um I'll I'll start answering the question then hand over to my to my colleague Mr. Jamieson. Um to understand the regulatory arrangements in Australia, we have um two pathways for u supplying in Australia. The first pathway is for uh seeking a TGA conformity assessment and the other pathway is where a manufacturer can use a conformity assessment certificate that's issued by another recognized um regulator from overseas. >> But in all cases, conformity assessment is a a cornerstone of what the regulations require. Um and then depending on the classification of of the device um the the elements in relation to conformity assessment then um are commensent with the risk of of the device itself. In terms of the numbers um that you quoted I I think Mr. Jamieson um those numbers of 4% are in relation to TGA conformity assessments.
Um, uh, John Gmerson, um, medical devices and product quality division. Um, thank you, Senator. Yes, those, uh, uh, percentages are roughly correct. Um, so that would be >> um, but but as as my colleague, um, Muffy uh, explained um, that's only those manufacturers who um, need to come to the TGA for certification. It doesn't uh include the uh bulk of manufacturers who have had equivalent certification from another regulator
>> from in other countries. I apologize.
>> If I just add just a couple of elements of context as well, Senator Professor Anthony, deputy secretary health products regulation which includes the TGA. Um we are like um many other regulators of riskbased regulators. So our our role is to um fundamentally recognize that there are bal the risks to balance in regulating therapeutic goods in Australia regardless of whether they're medicines, devices, biologicals or or others. And that risk is frequently one between safety and quality and access. And so we can set the bar very high on on safety and quality and ensure that Australians never have access to emerging or innovative um devices or therapeutic goods. Our role is to ensure that the balance is set appropriately between access and safety and quality. Uh and we do that in a number of ways and as as my colleagues have described, one of those is reliance on uh the decisions of overseas regulators. That's not just saying that um with with abandon. It's it's it's actually having an understanding around the practices of those other regulators and using those as inputs into our decisions. The only other thing I'd say is that it's it's important not to take those authorization decisions in isolation that our regulation of therapeutic goods occurs across the entire life cycle. So, we're balancing the risk between the pre-market authorization decisions and the postmarket monitoring and and vigilance mechanisms that we have in place for the life cycle of that
product. So it sounds to me then you would be familiar with rejection rates of other countries and assuming that's correct, how does our rejection rate compare to the rejection rate of other countries?
>> I think Sand to put it into context what a rejection actually means. Um the majority of applications that we receive that do not go on to um be registered on our register of Australian therapeutic goods, the majority of those are because the applicant has withdrawn their application as opposed to being um not approved by the TGA.
>> So of of those rejected devices, how many of those were due to withdrawals?
We would have to take that on notice, but the vast majority are um due to
>> Um Senator, if I can add there, um um we would take that on notice, but just um my understanding is uh from the figures reported that you've quoted um that rejection rate didn't include withdrawals. Uh withdrawals were in in
addition. So I understand for overseas medical devices that the those like assessments or you know the approvals are undertaken by forprofit bodies often paid for by the company that owns the medical device. So in those circumstances do do you apply any stronger review process because there might be some concern about um the independence of that assessment? I'm
assuming you're talking about notified bodies in Europe. Yeah. Okay. So, um the genesis of the notified bodies in Europe is that they they did actually start off as being government entities and then through processes and decisions made by the European uh Council, they were they were then privatized. Um similar to how um uh the TGA undertakes its work, it's a fee for service. So notified bodies also operate under a fee for service model just the same as TGA. Many regulators around the world are moving to fee for service as well. So the model is well established um in terms of conflicts and other um aspects to this that is something that is um deeply looked at by the competent authorities in the um the the um the countries where these notified bodies um are established. And there is a very rigorous mechanism under which the notified bodies are assessed and reassessed by the competent authorities and an overarching group that looks at and assesses them on a on a on a I guess a group um wide um perspective across
Europe. And so while we're talking about um overseas medical devices, so are all overseas warnings about device risks passed on by you to us consumers?
>> Um it does depend on the overseas warning and the actual um device itself and whether or not it's supplied in Australia. U my colleague Doc Dr. No, may like to um extrapolate on that a little bit.
>> Thank you Senator for the question. Marcel noj medical device and product quality divi division just that um it's a really important question to ask what happens in the postmarket space I think uh previously at this committee we've spoken about the various feeds that we have in respect to signals we look at adverse events we look at the emerging evidence we speak to international regulators and we do that monthly um in addition to that we have regular information exchange with them that includes information directly through to the postmarket teams as well as to our recalls teams. Sometimes when we look at actions that happen in other countries, we need to see whether those products are supplied in Australia. Additionally, sometimes things can occur in one particular country that don't necessarily occur in Australia because of the different population that we have. So we consider all of that, but where appropriate, of course, we will undertake market action if we feel so.
So it it's then when the warning is just inapplicable in Australia that it's not passed on but it otherwise is. Is that right?
>> If we if we believe there is an impact on the Australian population we will action. Yes.
>> Okay. Thank you. I think that's um
Senator there have been instances where there has been u community interest because they have become aware of something that's happening overseas where we will post something on our website to clarify that even though there might be a signal overseas that the product may not be available in Australia so that we're able to I guess um provide that information to the community to understand that they're in no danger here in Australia.
>> Thank you. That's my time up. >> Thank you. Yes. Thank you, Senator Flyer. Uh, Senator Roberts,