I was most privileged to be invited at a recent reception, hosted in April 2017, by the U.S. Consul General Mrs Fowler, in Double Bay, Sydney Australia.
The event, appropriately named Patient Day 2017 “Saving Lives through American Innovation” highlighted the immense contributions by US Medical Device manufacturers with much needed products for Australia.
I for one, was most touched by speeches made from three beneficiaries of products from Johnson and Johnson, Medtronic and Varian Medical Systems. Products, seen as having clearly contributed to the improved quality of life for those wonderful individuals.
At least for myself at a tender age from a bygone era in the 50’s, I know for sure that at one point in time and hopefully in the very far distant future, advances in Medical Device technologies would also allow me to also enjoy the same quality of life as I am enjoying today. As of now, everything looks good, possibly because of our vegemite , our beautiful weather ( and of course the odd exercise or three!!)
So how does the American sourced Medical Devices landscape look like in Australia.
A review of Medical Device approvals on the Therapeutic Goods Administration (TGA) website indicates that the largest number are for products manufactured in USA at 36.9 % of total approvals compared to 7.7% for products manufactured in Australia, 14% from Germany, 8.2% from China, 3.4% from France and only 0.3% from India.
In general terms, Medical Devices are assigned to one of five risk classifications, the lowest classification (Class I) equating to a low risk to end users with the highest risk (Class III,AIMD) given to products with the highest potential risk to end users.
In any circumstances, Medical Devices are required to comply to particular regulatory requirements to ensure Quality, Safety and Clinical efficacy. The risk classification is a mean to determine types of documents required to be assessed prior to TGA authorisation for supply.
Again, when one looks further at total Medical Device approvals, US leads the pack with 32.6% for the lowest risk (Class I) and bumper figures of 58.0% for the high risk III and 75.8% for AIMD (Active Implantable Medical Devices).
Remarkable figures attesting to the well regarded high quality and most advanced products from US.
RQSolutions (www.rqsolutions.com.au) is a team of strategic professionals with over 35 years in Medical Device Sponsorship, Registrations, Government Reimbursement and Quality Management in the Therapeutic Goods Industry. We have provided assistance to a large number of US clients.
Let us share with you, the various available options to register your Medical Devices in Australia.
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