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How to Register Your Device in Australia

Device approval in the most prominent nations among the Asia-Pacific region is a multi-faceted process that varies from country to country. Depending upon which market your company plans to enter, your process from regulatory approval to market could be relatively smooth and fast, or cost- and time-intensive. 

During OMTEC 2016, Evangeline Loh, Vice President of Global Regulatory Affairs for EMERGO Group, gave an overview of what companies can expect when attempting to enter Australia, China, India or South Korea.

This article provides a high-level view of how a company can enter the Australian market, and touches briefly on how that relates to neighboring Asian-Pacific nations. Part of what makes the Australian market so attractive is its willingness to utilize other nation’s approvals, specifically the European Union’s CE Mark. In fact, your device categorization in the EU will largely be the same in Australia. Further, the country has the 12th largest global economy, on par with Canada, and a total medical device market of $5 billion to $7 billion, according to EMERGO.

With any regulatory approval, the first step is identifying the classification of your device. Each nation varies in the way that it handles classification. In Australia, you use Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. As mentioned above, most CE Marking will be accepted as part of your registration process. (To see how other Asia-Pacific nations classify devices, see the sidebar, Classifying Your Device.)

After classifying your device, most countries require a sponsor for approval. In Australia, China, India and South Korea, companies need to appoint either a sponsor or agent. However, each nation has different procedures for changing the license holder, so select your sponsor mindfully. “This is an element in almost all regulatory systems. If you’re not physically based in that country, you need to identify a partner and sponsor who is [based there]. Depending on that country’s legislation, that entity could have greater responsibility and greater rights over that registration,” Loh said.

In Australia, the process for transferring the sponsorship is relatively fluid and easy, provided that your original sponsor is willing to relinquish their holding. For comparison, in China, you will own the certificate and it is valid for five years. However, your agent in India must be granted Power of Attorney over your device. In India, that means you are effectively “married” for the duration of a three-year period. If you wish to switch distributors, you would need to begin your registration process again.


Classifying in China, India
and South Korea

In China, one would use Order No. 15 from the Chinese Food and Drug Administration (CFDA). India’s Drug Controller of India (DGI) only requires certain devices to be registered, so Loh recommends a careful examination of where your device fits, because you may have a less-intensive path to approval if your device does not need to be registered. South Korea’s process can be more complicated. Applicants will need to refer to the South Korean device database, work with the Ministry of Food and Drug Safety (MFDS) and study predicate devices on the market.

“These countries largely leverage device approvals from other countries,” Loh said. “That’s an exciting development that points toward global harmonization of regulatory standards.”

Specifically, Loh says that nations in the Asia-Pacific region will utilize CE Marking and recommendations from the International Medical Device Regulators Forum (IMDRF). Some of CFDA’s revised device code includes language similar to that found in IMDRF recommendations.


Appointing a distributor as your in-country sponsor also means that if you switched distributors, you may need to re-print labels, manuals and deal with products already in the marketplace that contain your previous distributor’s name and address.

Edgar Kasteel, Manager of the Distributor Division at EMERGO, told ORTHOWORLD that in some nations, “Smaller companies like the idea of having their distributor serve as Registration Holder, because they don’t have to pay upfront for the regulatory approval. But what should be taken into consideration is that once the distributor submits and receives that approval, that distributor owns the registration. The moment you want to switch distributors, you have to start the whole registration process from scratch.”

“That means, if it took you two years to get your approval and three additional years to determine that the distributor wasn’t the right fit, you’re five years in and you still haven’t sold much. Then you have to invest another two years into registration. Sometimes you’re seven years out of the market that you want to be in. That’s a really costly mistake.”

For companies interested in entering the Australian market, the next step would be the submission of a design dossier. Loh notes that this document is largely the same as a European technical file. If your company has already prepared a European technical file for CE Mark approval, there will not be much need to amend that document, she says.


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