As we watch the changes in Europe evolve under the Medical Devices Regulations (MDR), we are starting to see an increasing trend where companies that had previously used Europe as a fast pass into Australia, starting to go directly to the Therapeutic Goods Administration (TGA) for their conformity assessment. Previously, we saw the agency struggling to meet their specified timelines, and sometimes, taking well over one year before you’d see an approval.
Over the last few years and multiple reviews, there has been a focused effort by the TGA to not just throw additional resources at the problem but they’ve spent more time in developing their internal processes and systems. That, in turn, has led to a reduction in the time taken across all facets of the medical device registration process.
Looking specifically at the conformity assessment process, it is similar to that of applying for a CE certificate through a notified body. Fundamentally, similar to the European Union (EU), the manufacturer is responsible for demonstrating compliance to the essential principles (EP) prior to applying for a conformity assessment or an inclusion on the ARTG. EP can be broken into two groups. There are six general EP that apply to all devices. There are a further nine EP about design and construction that apply to devices on a case-by-case basis.
General Essential Principles (EP):
Design and Construction EP:
Manufacturers can leverage a number of avenues to provide evidence of compliance to these principles. The TGA does have a handy checklist that provides some guidance on how to document and present these various requirements. Manufacturers can choose to use existing standards, including the standard orders and medical devices (as published on the TGA website). Alternative methods can include:
One area that can sometimes catch a manufacturer unaware are those that are not associated with the TGA directly but are required under other regulatory frameworks. An example provided by the TGA include that of a manufacturer of an electrically powered medical device that has radio communications functionality. The manufacturer must comply with each of the appropriate electrical, spectrum, communications, customs, medical, etc. requirements that apply nationally and in each of the states and territories. These don’t always have a correlation with the TGA, but are a completely separate regulated area. It’s critical that this is understood when considering expansion into the Australian market.
Another area that we see a struggle for manufacturers is the area of clinical evidence. The TGA has published a guidance document, “Clinical Evidence Guidelines: Medical Devices” that manufacturers should use and fully understand prior to submitting their evidence for review. This document provides clear guidance on meeting the specific requirements with regard to presenting your clinical data. Unless the manufacturer is clear on this guidance, the company can anticipate questions from the regulator, and potentially, a failed application.
As outlined on the TGA website, broadly speaking, clinical evidence should provide a clinical assessor with a current and accurate picture of the state of scientific knowledge in relation to the treatment modality, in general, to which a device relates, and with respect to the particular device, specifically. From this information, an acceptable risk or safety profile is demonstrated for a medical device by showing that it performs as intended and that all identified undesirable effects and hazards, having been minimized during the development process, are outweighed by the benefits. The detail and extent of the clinical evidence will depend on the classification of the device, its nature or design and the purpose(s) for which it is intended. This clinical evidence should be updated and systematically reviewed periodically as new information based on post-market surveillance activities and product experience becomes available.
The final critical point for manufacturers to understand is that there are specific differences between Australia (AU) and European conformity assessment procedures. We see time and time again manufacturers who’ve previously submitted in Europe provide the same information to the Australian regulator. This is not an acceptable approach. The final graphic shows a high-level difference between both documentation and classification from EU and Australia. Note that these will likely change with the introduction of the MDR.
If you’re considering the Australian market for your product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that the TGA is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.
Reprinted with permission from the author. This post was originally published at http://brandwoodbiomedical.com/tga-process-for-conformity-assessment-in-australia/.
Grant Bennett is a senior consultant with Brandwood Biomedical and provides expert consultancy services relating to regulatory compliance in Australia, New Zealand and the Asia Pacific. Grant is also responsible for management oversight of all Australian consulting projects.
|Download Free Resources|