Abdera Business Services get a lot of enquiries from international companies seeking TGA sponsor for medical devices, health and wellness products, as well as natural complementary supplement products to import and sell in Australia.
Most of our clients are unsure of what is required of their business to get their therapeutic goods approved and ready for the sale in the Australian healthcare industry.
We thought we would compile their frequently asked questions to help you. These questions and answers may be a great starting point when seeking to do business in Australia.
While our healthcare regulatory system may be complex, it is designed to ensure that only safe and good quality therapeutic goods are supplied for use in Australia.
The Therapeutic Goods Administration (TGA) is Australia’s equivalent of the FDA in the USA. They are the regulatory authority for therapeutic goods, under the Australian Government Department of Health.
In Australia, therapeutic goods must be approved and included on the Australian Register of Therapeutic Goods (ARTG) before they can be sold to Australian consumers and the health industry.
The sponsor is responsible for applying to the TGA to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG).
Foreign manufacturers often appoint domestic sponsors in Australia to act on their behalf. The TGA sponsor is legally accountable for the product quality on the Australian market.
Go to our blog – What is a TGA sponsor? Do I need one? – for more information
Your appointed TGA sponsor, on behalf of your organisation is responsible for applying to the TGA to have your therapeutic good/s included on the Australian Register of Therapeutic Goods (ARTG).
Once the product has been approved by the TGA, your TGA sponsor certifies a range of matters about the product/s as part of your entry in the ARTG.
At any time, the TGA can request information and/or documents from the sponsor and failure to respond or to provide sufficient material for the TGA may result in the TGA sponsorship cancelled or suspension of the product from the ARTG.
For example, an American company who wants to import and sell a new medical device in Australia will appoint an Australian TGA sponsor. Their sponsor is required to substantiate that the medical device complies with the relevant Essential Principles of the TGA. The sponsor must also substantiate that the relevant conformity assessment procedures have been applied to the device. (This means that the manufacturer must be able to demonstrate that both the medical device and the manufacturing processes used to make the device conform to the requirements of the therapeutic goods legislation).
TGA sponsors are required to keep various records for all their therapeutic goods held in the ARTG, particularly about the supply of the goods in Australia and any adverse events.
Your therapeutic goods will need approval from the TGA to sell and distribute in Australia. You will also need to have your product/s listed on the ARTG.
Your TGA sponsor can help you navigate through the approval process to ensure your therapeutic product meets the criteria as assessed by the TGA. These include manufacturing requirements, and product and labelling requirements. There may also be additional requirements specific to the type of product.
Review the relevant regulatory guidelines to make sure that your product is able to meet all necessary legal requirements.
For example, before a TGA sponsor applies for TGA approval for complementary medicine on behalf of a UK company, they need to be able to certify that:
1. Only low-level claims are made about the health benefits of the product
2. Evidence is kept supporting the claims
3. The product has been manufactured in a facility that satisfies TGA regulatory requirements
4. The product only contains low-risk ingredients approved by the TGA.
Medical devices with a high-risk classification, such as pacemakers and joint replacement devices, will be under greater scrutiny. Therefore, they will require more evidence in the application process. Lower risk classified medical products such as bandages, will require less evidence to demonstrate they are safe and fit for their intended purpose to Australian consumers.
Your TGA sponsor will be able to advise on the documentation required for your therapeutic good to obtain TGA registration.
Yes. When setting up a business in Australia one of the requirements is to nominate a resident director, also known as a nominee director.
Your Australian company will need –
One nominee director/resident director who must ordinarily reside in Australia for a proprietary company (with ‘Pty’ in its name).
OR
Three directors for a public company (with shareholders), with at least two resident directors, who must ordinarily reside in Australia. For example, two directors can be permanent residents and the third can be a non-citizen.
For global companies setting up business in Australia it may be difficult to find a suitable or eligible nominee director. Abdera offers resident director services, where you can nominate one of our qualified partners as your company’s nominee director.
Read more information here –
I want to know more about resident director services
I require an experienced and suitable resident director for my business in Australia
Yes, your CE Marking certificate can be used as part of your Manufacturers Evidence for all medical devices (except for Class I Non-sterile, non-measuring devices) and used for TGA’s review and acceptance.
A CE Marking certificate indicates your product has already been assessed to meet high standards in safety, health and environmental protection requirements.
Your conformity assessment process certification, as part of your CE Marking application, can be used as evidence of conformity when registering with TGA. This will result in time and money savings during the certification process.
Yes, within the scope of the TGA registration procedure, TÜV SÜD is recognised.
TÜV SÜD is acknowledged as an auditing organisation under the MDSAP, therefore being a part of the MDSAP can significantly help manufacturers and companies achieve TGA approval to supply their medical devices on the Australian market.
In most cases where our client has had a TÜV SÜD with a low-risk medical device, we have been able to get registration within three months.
Yes. The evidence and documentation supporting your FDA approval for the same medical device, will be considered by the TGA. It can be used for requests for abridgement of TGA conformity assessments or as the documentation required for applications for inclusion of medical devices in the ARTG.
The TGA will also accept specific evidence and documentation issued by Health Canada and pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB), whatever is applicable.
From the Therapeutic Goods Association, in the year 2018-19, their average processing times for inclusion in the ARTG for Class 1 Sterile medical devices was 42 days, Class I (measuring) medical devices was 97 days and Class IIa was 188 days for 90% of applications.
For conformity assessment applications in 90% of medical devices processing times were 238 days and IVDs took 227 days in 90% for the year 2018-19.
Other medical devices and IVD processing times can be read here.
Other factors that can speed up your application, include if your manufacturer is already TGA approved, your therapeutic good has CE Marking and TUV certification, or FDA approval.
Your company and TGA sponsor can ensure delays are eliminated by:
1 – Ensuring your application is lodged complete with all the paperwork and evidence as required for the type of product as part of its application.
2 – Ensuring the clinical information provided in your application supports the requirements of the Australian Clinical evidence guidelines documents for medical devices.
3 – Your TGA sponsor responds quickly to the TGA to any requests for additional information.
Also known as a TGA agent, TGA consultant, or regulatory affairs consultant, even your Australian distributors can be your TGA sponsor. There are many businesses in Australia you can approach to represent your company, however, we recommend you complete due diligence when choosing a TGA sponsor. The TGA sponsor holds your right to market in Australia.
An experienced and expert TGA sponsor can reduce your risk of liability, assist in getting your therapeutic goods to market quicker, as well as ensuring you are always compliant with TGA regulations.
Our extensive experience in helping international companies and their requirements to meet compliance with the TGA, means we can provide easy to understand and relevant information you need to make educated decisions.
Don’t let getting TGA approval prevent or slow your business from setting up in Australia – our TGA sponsor services solution gets your business into business!
