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 Therapeutic Goods Administration (TGA) for their conformity assessment. Earlier times saw the regulator struggling with meeting their specified timelines and sometimes blowing out to well over 1 year before you’d see an approval.
Over the last few years and multiple reviews, there has been a focused effort by the regulatory to not just throw additional resources at the problem but they’ve spent more time in developing their internal processes and systems which in turn has seen a reduction in the time taken across all facets of the medical device registration process.
Generally, the industry trend has been to provide the TGA with a copy of the manufacturers CE Certificate and move forward with the application. For those that do not need any additional supporting evidence and review by the regulator, the device application is then submitted, and according to statistics show that most are included on the Australian Register of Therapeutic Goods (ARTG).
As can be seen in the below graphic, there are specific products that will need either a Level 2 audit or a Conformity Assessment by the TGA.
Australian Conformity Assessments
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 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 Australian Register for Therapeutic Goods (ARTG). The Essential Principles can be broken into two groups. There are six general Essential Principles that apply to all devices. There are a further nine Essential Principles about design and construction that apply to devices on a case-by-case basis.
– Use of medical devices not to compromise health and safety
– Design and construction of medical devices to conform to safety principles
– Medical devices to be suitable for the intended purpose
– Long-term safety
– Medical devices not to be adversely affected by transport or storage
– Benefits of medical devices to outweigh any side effects
Principles of design and construction:
– Chemical, physical and biological properties
– Infection and microbial contamination
– Construction and environmental properties
– Medical devices with a measuring function
– Protection against radiation
– Medical devices connected to or equipped with an energy source
– Information to be provided with medical devices.
– Clinical evidence
– Principles applying to IVD medical devices only
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:
-a documented and detailed risk analysis
– the results of testing of the medical device
– literature searches
– copies of the label, packaging and Instructions for Use to demonstrate that information requirements have been met
– expert opinion
– the design dossier, if applicable.
Other Regulated Areas:
One area that can sometimes catch a manufacturer unawares are those that are not associated with the TGA directly but are required under other regulatory frameworks. Examples provided by the TGA are 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 a completely separate regulated area. It’s critical that this is understood when considering the Australian market.
Other areas that we see a struggle for manufacturers is the area of Clinical Evidence. The TGA have 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, you can anticipate questions from the regulator, and potentially a failed application.
As outlined on the TGA site, 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 then 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 minimised 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 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 AU. 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.
If you’d like more information on gaining an Australian Conformity Assessment, be sure to contact us for a free discussion.
If you would like to download the slides from above please click here.