Regulatory Assessment of Medical Devices in Australia is one of the most simplified in the world and in particular where the product is already approved for supply in Europe.
If your product is low risk (potentially with a risk classification of I), then TGA approval turnaround time is less than 24 hours.
If the risk classification of your product is higher than I but lower than IIb, then the TGA approval turnaround time has been slashed recently to some 4-8 weeks from application date. A tremendous effort by our colleagues at the TGA in their goal to make available to the market, some of the newest life saving devices in the world.
Fees and charges for applications are minimal when compared in other countries and therefore overall costs for handling your project is most favourable if not negligible against your return on your investment.
All you need is a reputable Regulatory Consultant Agency to take you through the process and promptly coordinates the receipt of required documentation and have your product approved within the shortest possible timeline.
Our experience as your Australian Agency at RQSolutions goes back to 1990, at the time, the Therapeutic Goods Act was introduced.
Our expertise with a large range of types products, will ensure your own product is launched within the shortest possible time and sometimes within a 2-week period of your phone call for assistance.
As experts in the field, we also continuously monitor the Regulatory Landscape and like to share the immense opportunity for Regulatory and Sales/Marketing professionals.
So, what is the source of these products – where are they manufactured.
The publicly accessible TGA approvals website, confirms again that USA supplies the majority of products in Australia increasing in numbers as the device increases in risk.
In stating this fact, have we then established a high purchase value base for Medical Devices because of their country of origin and does this present with opportunities for other countries to supply equivalent products at a lower cost to the Australian healthcare system. As such, with then a higher profit margin.
On the basis that the majority of TGA submissions (from class Im/s to IIb and non-drug containing Class III and AIMD) are based on European approved CE marked products and the assumption that for the majority of products that are sourced from US are manufactured by third party contractors outside US, then how to encourage sourcing from outside US. A difficult question at most times to answer.
- Is it the uncertainty of the Australian TGA regulatory system which essentially is most straightforward? – How to inform the uniformed?
- Have we set ourselves in stone with preferred established suppliers and just trust that label and brand name. (In other words, because it is a VW, then we know for sure that it is of the highest quality. Is that really true L. Give me a break).
- Are we just sitting in a comfort zone and just believe in the country of origin? Give me a break again.
But remember, the Notified Body that has issued a CE mark to the product manufactured in US may be the same Notified Body that will issue a CE mark if the product was made in Australia or India or China. In fact, all Notified Bodies are subject to verifications, following practices established by competent authorities in Europe.
So, what do the figures tell us:
Source of Medical Devices with a risk classification of I (Low risk)
| Selected countries | % of total TGA approvals |
| Korea | 1.2 |
| Japan | 1.4 |
| Taiwan | 2.0 |
| Italy | 2.4 |
| France | 2.5 |
| Pakistan | 3.0 |
| India | 4.9 |
| United Kingdom | 7.0 |
| China | 11.8 |
| Australia | 13.3 |
| Germany | 15.7 |
| USA | 34.7 |
Source of Medical Devices with a risk classification of Is-Sterile (Low-Medium risk)
| Selected countries | % of total TGA approvals |
| Korea | 0.2 |
| Japan | 0.0 |
| Taiwan | 0.8 |
| Italy | 2.5 |
| France | 3.2 |
| Pakistan | 0.1 |
| India | 3.7 |
| United Kingdom | 9.2 |
| China | 21.9 |
| Australia | 8.0 |
| Germany | 9.9 |
| USA | 40.6 |
Source of Medical Devices with a risk classification of Im-Measuring (Low-Medium risk)
| Selected countries | % of total TGA approvals |
| Korea | 2.0 |
| Japan | 4.9 |
| Taiwan | 5.8 |
| Italy | 2.7 |
| France | 3.8 |
| Pakistan | 0.0 |
| India | 0.4 |
| United Kingdom | 9.0 |
| China | 13.7 |
| Australia | 2.2 |
| Germany | 13.0 |
| USA | 42.4 |
Source of Medical Devices with a risk classification of IIa (Medium risk)
| Selected countries | % of total TGA approvals |
| Korea | 0.0 |
| Japan | 3.9 |
| Taiwan | 3.2 |
| Italy | 4.0 |
| France | 4.2 |
| Pakistan | 0.0 |
| India | 2.1 |
| United Kingdom | 7.6 |
| China | 13.5 |
| Australia | 4.7 |
| Germany | 14.7 |
| USA | 42.1 |
Source of Medical Devices with a risk classification of IIb (Medium risk)
| Selected countries | % of total TGA approvals |
| Korea | 3.7 |
| Japan | 2.4 |
| Taiwan | 1.0 |
| Italy | 4.4 |
| France | 6.9 |
| Pakistan | 0.5 |
| India | 2.1 |
| United Kingdom | 6.0 |
| China | 7.3 |
| Australia | 3.2 |
| Germany | 17.0 |
| USA | 45.4 |
Source of Medical Devices with a risk classification of III (High risk)
| Selected countries | % of total TGA approvals |
| Korea | 0.1 |
| Japan | 0.7 |
| Taiwan | 0.0 |
| Italy | 4.5 |
| France | 7.0 |
| Pakistan | 0.0 |
| India | 5.7 |
| United Kingdom | 6.1 |
| China | 0.1 |
| Australia | 2.2 |
| Germany | 10.0 |
| USA | 63.6 |
Source of Medical Devices with a risk classification of AIMD (High risk)
| Selected countries | % of total TGA approvals |
| Korea | 0.0 |
| Japan | 0.0 |
| Taiwan | 0.0 |
| Italy | 8.9 |
| France | 0.6 |
| Pakistan | 0.0 |
| India | 0.0 |
| United Kingdom | 0.3 |
| China | 0.0 |
| Australia | 2.3 |
| Germany | 9.7 |
| USA | 78.3 |
*data source – Publicly accessible Australian Register of Therapeutic Goods
USA is the major source of product supplies in Australia so let’s bring in the competition and compete on price for substantially equivalent high quality CE marked products that can be sourced from other geographies.
If you are one of the owners of any of the TGA approvals in the classification category above than you are already experiencing high returns on sales but then if you are not and have a comparable product to what is approved with improved benefits and claims and a lower proposed premium reflecting your lower production costs than the opportunity is at your fingertips.
Email us using our contact sections at RQSolutions and let us show you the simplicity of the regulatory submission and reimbursement process.
Cheers,
George Azoury
Chief Executive Officer
RQSolutions Pty Ltd
