Some additional clarifications for Ginger and Rashmi.
1. Ongoing MRA status of TGA issue of CE certificates. 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 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
Rashmi - you need to ensure that you get your TGA-issued CE certificate 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), start today.
2. Acceptance of MDSAP vs ISO 13485
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 ISO 13485 certificate was required as the existence of the CE certificate is evidence in its own right that
both product and quality system requirements have been met. They were comfortable to do this because of the nearly identical regulatory requirements in Australia and Europe and thus 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 put in place requirements which addressed both QMS and Product requirements
and which specifically ensured that the QMS addressed Australian regulatory requirements. Therefore TGA requires
two pieces of evidence:
- a product approval from US/Canada or Japan plus
- an MDSAP certificate which specifically includes Australian requirements in its scope (or a Japanese QMS certification). An ISO 13485 certificate alone is not acceptable.
3. Application Audits and Technical File DocumentationFor 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 (it's the green bar in the graphic in my original post). 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 applicaiton 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 AssessmentAny 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 a Notified Body conformity assessment and takes a minimum of 9 monhts to process. This is mandatory for any Class III device which contains an integral medicine or a biological origin material. TGA does not accept international evidence alone for these highest risk devices (but may abridge their assessment depending on the international reviews already undertaken).
All of this is explained in more detail in a
recording of a live webinar (complete with Q&A).
Hope this clears things up a little!
------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com------------------------------
Original Message:
Sent: 06-Dec-2019 08:30
From: Anonymous Member
Subject: TGA conformity assessment and MDSAP
This message was posted by a user wishing to remain anonymous
I understand TGA is part of the MDSAP program. The MDSAP is essentially a 13485 audit with the addition of regional requirements. Is a product specific audit also part of the audit to receive a CE mark? I know the EU's conformity assessment looks at both the qms and product. But I am not sure if the TGA audit looks at both to receive the CE mark. I look forward to any clarification. Thanks.