The Australian healthcare system largely depends on imported Medical. Refer to a previous white paper on the source of medical device manufacturers. Our private hospital insurance premiums are continuously rising (An average of 3.95% in 2018) claimed to be due to a number of factors including the aging population and the cost of new medical technology.
The cost of goods would be expected to be highest from US and Europe compared to Asia, a contributing factor to what we are paying for any particular surgical procedure. Then again, if the technology is only available in some geographies then be it, we may have no choice.
Bearing in mind, the 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.
All you need is a reputable Regulatory Consultant Agency to take you through the process.
Our experience as your Australian Regulatory partner at RQSolutions goes back to 1990, at the time, the Therapeutic Goods Act was introduced. Let us take you through the submission process. We will promptly coordinate the receipt of required documentation and have your product approved within the shortest possible timeline.
There are a set of basic questions in our assessment of your products and where the product is CE marked and documentation would be already available since your certification authority (Notified Body) has already done the work.
For products with a risk classification of I (low risk)
The TGA application is a self-certification approach based on you meeting the Australian Essential Principles Checklist. Equally important is that you have solid post market complaints procedures in place.
If you are uncertain, let us assist you with creating required documentation. Fees are minimal.
For products with a risk classification of Is, Im, IIa, IIb, III, AIMD (Medium to High risk)
Products in this category tend to be CE marked and on the basis documentation in place are normally acceptable as assessable TGA documents. If you tick Yes to the following, than you are on your way with fast track TGA approvals when compared with non-CE marked products. In some circumstances, minor changes to documentation are required.
| Yes | No | |
| Do you have a CE certificate | ||
| Does your product claim correspond to the product’s intended purpose | ||
| Do you have an EU compliant label | ||
| Do you have a risk report | ||
| Do you have a clinical report | ||
| Do you have the EU Essential Requirements Checklist[1] | ||
| Do you have post market complaints procedures |
[1]The EU Essential Requirements Checklist is substantially equivalent to the Australian Essential Principles Checklist – A template showing key differences can be acquired by request. Please go to contact section atRQSolutions
If you are uncertain, let us assist you with creating required documentation. Otherwise you are on your way to have your product approved and promptly launched in Australia.
| Risk Classification | |||
| Class I | Class Is to IIb | Class III/AIMD | |
| TGA Forecast Approval turnaround time[2] | 24 hours | 4 – 8 weeks | 4 – 6 months |
[2] Assessment time will depend on TGA workload but normally will be less for medium to high class products dependent on the quality and completeness of your documentation. TGA assessment time is longer for medical device /drug combinations
TGA fees are also minimal – Refer to this link for the 2018-2019 financial year fee structure
So where are the opportunities for any manufacturer.
An analysis of Medical Device approvals for period 2014 -2018(Jun), confirms that US manufacturers enjoy the biggest share, with Germany at distant second. Figures nevertheless show a decreasing trend from US over the period and what appears to be an increasing trend for products imported from China. Does it then mean that, equivalent approved products from China would be sold at a lower cost then their US counterparts. Or per normal market pricing, benefiting those who are manufacturing a lower standard cost. Now this is the big questionable opportunity!!
If we have a discussion on the perception that rising health care costs are due to the cost of new medical technology, then Its rather a mixed soup of interpretations here.
Where are the opportunities when considering the various risk classifications for the selected countries per chart?
Figures indicate:
- A decreasing trend with products with higher risk classifications such as class III and AIMD (active implantable medical devices e.g. pacemakers, Brain electrical stimulation systems, Cochlear implants, Radionuclide systems etc)
- A rather platooning trend with other risk classifications
One could assume with some reservations I am sure that the increasing cost of new medical technologies would correspond to an increasing number of approvals in Medical Devices with higher risk classifications.
One can also equally argue that new TGA approvals may be related to new technologies then justifiably their introduction into our healthcare system gives that rise to higher cost burdens.
The analysis to come in future white papers is how many of these are new and how many are just new players in the field competing on equal footings with similar products in Australia.
I am interested in your comments and what particular areas, you would like us to expend on.
Yes, we are open to constructive criticism. That’s how we all improve to do better things. Bring it on!
So, if you are new to the Australian Regulatory Landscape and thinking to supply your products in competition to others, allow us to assist you with manoeuvring through the TGA requirements maize and even advise of your competitive market.
If you have already TGA registered products, let us also assist you with rationalising what you have and show you, significant sponsorship and TGA annual cost savings. Our first consultation is free.
RQSolutions specialises in Australian Sponsorship,TGA Registrations and Licences- Medical Devices , PLAC Reimbursement of Medical Devices, Quality Management Systems and auditing, Pharmacovigilance, Complaints Handling and Compliance, Cosmetics and compliance, EU representation, Regulatory Intelligence, Training, Document Management, Distributor Appointments We work with you and will achieve your regulatory goals – RQSolutions
