TGA acceptance of international device reviews – clearing the fog
A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices. Here we answer some common questions and deal with some misconceptions.
First and at the most basic level – TGA always requires a Conformity Assessment to be conducted of a medical device manufacturer. This can be either done directly by TGA, or TGA will accept international reviews in lieu of its own assessment. The agency will then register medical devices within the scope of that assessment. For higher risk devices supported by international evidence, TGA does a second, desktop review, called an application audit.
ISO 13485 alone is not sufficient
We are commonly asked – can TGA accept ISO 13485 certificates as evidence of compliance. Simply put – no. TGA’s view is that in order to enter a product on the Australian Register of Therapeutic Goods (ARTG) they need evidence of both product and Quality System compliance.
TGA has for many years accepted CE certificates alone as evidence for medical device registration. Note that no separate ISO 13485 certificate was required as the existence of the CE certificate was evidence in its own right that both product and quality system requirements have been met. TGA was comfortable to do this because of the nearly identical regulatory requirements in Australia and Europe. This meant they were comfortable that the QMS under a CE would address Australian requirements.
When TGA extended the acceptable evidence to include US, Canadian and Japanese requirements they needed to see evidence which addressed both QMS and Product requirements. That evidence also had to specifically show that the QMS addressed Australian regulatory requirements. Therefore, TGA requires two things:
- a product approval from USA, Canada or Japan plus
- an MDSAP certificate which specifically includes Australian requirements in its scope (or a Japanese QMS certification).
So, for these reasons, an ISO 13485 certificate alone is not acceptable.
All of this is summarised in the below graphic.
Application Audits and Technical File Documentation
For any registration based on international review evidence, TGA reserves the right to review Technical File documentation under a desktop review process known as an Application Audit, and then makea local decision – it’s the green bar in the above graphic. For higher risk devices (all Class III, AIMDs and most implantable IIb devices) that review is mandatory and attracts a fee.
As TGA feels its way forwards accepting US/Canadian/Japanese evidence for the first time, they are likely to do a lot of application audits on applications supported by evidence from these countries. That should reduce with time.
An application audit typically is a review of :
- Product labelling/IFU
- Risk Management Report
- Clinical Evidence Report
- Essential Principles Checklist.
Any applicant to TGA should hold these documents, maintain them up to date and be prepared to provide them to TGA on demand. Note that this regulatory framework is based on most applications being approved on the certificates alone but a tacit understanding that the manufacturer has a Technical File that addresses Australian requirements and will provide it immediately on request. “Immediately” is typically within 20 working days of written TGA demand. Of greatest importance is the Clinical Evidence Report – which should address the TGA Clinical Evidence Guidelines, which are essentially the same as the European MEDDEV 2.7/1 version 4.
Direct TGA Assessment
Any applicant who cannot meet the international evidence requirements supported by CE/US FDA/Canadian or Japanese reviews will need to apply for direct TGA conformity assessment. Note that this is the same process as a Notified Body conformity assessment and takes a minimum of nine months to process, sometimes longer for complex high risk devices.
Direct TGA Conformity Assessment is mandatory for any Class III device which contains an integral medicine or a biological origin material.
Note that TGA does not accept international evidence alone for these highest risk devices – but may abridge their assessment depending on the international reviews already undertaken. For example, TGA may postpone an ISO 13485 audit if a manufacturer seeking assessment already holds a certification issued by a European Notified Body. This is explained in detail in the TGA guidance on: Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)
What about CE certificates issued by TGA – how will that work under the MDR?
A Mutual Recognition Agreement (MRA) between Australia and Europe allows TGA to act as a Notified Body to assess Australian manufacturers against European regulations and issue medical device CE marks. We are commonly asked if TGA will continue to do this under the MDR.
We have authoritative advice from TGA that they will continue under the Australia – Europe Mutual Recognition Agreement to act as Notified Body under the MDD, but that they will not transition to act under the MDR. TGA are currently extending CE certificates issued under the MDD for the full grace period (to May 2024), providing there are no substantial changes to the product. This gives all manufacturers with TGA issued CE certificates the maximum time to transition to a Notified Body and gain separate MDR certification from an MDR designated Notified Body.
So Australian manufacturers currently CE certified by TGA should be in direct communication with TGA about transitions, to ensure that your TGA-issued CE certificates are extended and then seek a Notified Body to gain an MDR CE certificate before May 2024. Given the long waiting times for Notified Bodies (typically 12-18 months before they will accept your case), any manufacturer not already in contact with a Notified Body should start today.
All of this is explained in more detail in a recording of our live webinar complete with Q&A.
Hope this clears things up a little!
We offer deep support for navigating international regulatory processes. 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)