Grant Bennett, General Manager of Brandwood Biomedical gave a presentation at a Medtechs Got Talent Workshop held in Melbourne a few weekends ago. The focus of the presentation was the various requirements around the development of medical technology. Grant explained what these individuals and companies should be focusing on when taking their devices into Australian, European and US markets. During the meeting, it became apparent that there was significant interest around the changes implemented late last year by the federal government, and the use of notified bodies in Australia. It appeared that there still remained a lack of understanding around what this actually meant to local Australian manufacturers.
The history behind this goes back to the creation of the regulatory system in Australia. Up until the end of 2014, there was a single pathway for Australian manufacturers, and that was for the Australian Manufacturer to have a direct conformity assessment conducted by the Therapeutic Goods Administration (TGA). This direct conformity assessment is in simple terms, a formal review and acceptance of the technical documentation generated by the Manufacturer throughout the development of their product. Only once the TGA had accepted this evidence, could the Australian Manufacturer submit an application for inclusion on the ARTG (being the product is registered to sell in Australia). If the Australian Manufacturer also wished to launch the product to the European markets, they would need to either separately, approach a Notified Body to obtain a CE Mark, or have the TGA increase the scope of their conformity assessment to include a review of the technical documentation against the Medical Device Directive (where the TGA would issue the CE Certificate).
The challenge with this approach was that overseas manufacturers could simply approach a Notified Body, obtain a CE Certificate and submit an application to the TGA for inclusion onto the ARTG, which in most cases would be cleared in just a few weeks (for the lower risk devices). This caused significant delays for the Australian manufacturers and was highly uncompetitive, where Australian Manufacturers would be waiting up to 18 months for the TGA to complete their conformity assessment, while competitors entered the market in as little as a week!
During October 2014, the government introduced new legislation which leveled the playing field between overseas and local manufacturers. This meant that (effective October 2015) Australian Manufacturers could approach a notified body directly for their conformity assessment, giving them access to both the Australian and European markets with only the one notified body. This significantly improves time to market for Australian manufacturers, and levels the playing field against international competition. This process allows Australian manufacturers to negotiate the speed of the issuing of their CE certificate with the notified body, which could not be done while using the TGA.
This doesn’t mean TGA will no longer conduct conformity assessments. Some local and international companies may wish to continue using the TGA for their conformity assessment if this fits their model. TGA will also continue to perform conformity assessments on the highest risk devices regardless of the where the manufacturer is located or if they hold a CE Certificate (these include devices containing medicines (e.g. drug eluting stents) or tissues of animal, biological or microbial origin (e.g. biological heart valves), or Class 4 IVDs, (e.g.Hepatitis C or HIV diagnostics).
What will also still remain in place is the mandatory Level 2 Application Audits (these are referring to desk audits) conducted with the TGA. These level 2 audits apply to large number of Class III devices manufactured either locally or internationally.
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