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.


The only addendum to your submission may be an Australian Declaration of Conformity (ADC), which is basically your attestation of compliance to Australian device regulations. Once you’ve classified your device, you can download a template for your ADC here.

Following that, you’ll need to submit your manufacturer’s evidence. Again, this is largely the same evidence that you would have used for your CE Marking.

It is here that the path begins to diverge from that of CE Marking. For Class III devices (which include total and partial hip, knee and shoulder replacements), there is a mandatory Level 2 application audit. If you have a device with a classification lower than Class III, you may be selected for a random audit by the Therapeutic Goods Association (TGA). That means, in addition to having your CE Marking, there would be a review of certain documents by TGA to determine whether your application complies with TGA and whether the documents submitted by your sponsor are correct.

Then, in addition to the Level 2 audit, certain devices require a TGA Conformity Assessment Certificate. If you have medical device with ancillary medicinal products, or devices with animal tissue, you would be required to acquire a TGA Conformity Assessment, for which you can apply for here. For Class IIb devices, that means an examination of your quality assurance procedures. For Class III devices, that means an examination of quality assurance procedures and a review of your product design. (You can find the full list of Conformity Assessment requirements by classification in a downloadable document, here.)

For all other devices, the submission process can be conducted electronically in its entirety. For devices at the level of Class IIb or lower, the submission is shaped by device family or what they call in Australia “kinds” of medical devices. These are devices with the same classification, same intended purpose and the same Global Medical Device Nomenclature (GMDN) code.

For Class III devices, the submission process is conducted with the same classification and intended purpose but substitutes GMDN codes for Unique Product Identifiers (UPI), which are a unique way to identify your device, not unlike FDA’s UDI program.

The only permissible differences within UPIs are called variances, which accommodate anatomical differences. These would be differences in sizes and lengths, differences in anatomy. Devices cannot vary from their intended purpose which is determined from all sources of information that accompany the device such as the label, Instructions for Use (IFU), manufacturer’s technical documentation describing the mechanism of action of the device and any other advertising material submitted to TGA.

Invariably, a manufacturer with a Class III CE Mark attempts to enter Australia and realizes that they have many more UPIs than they had thought, Loh said.

“One of the regulatory strategies we recommend is that you carefully consider each UPI. Each UPI is an ARTG listing and that incurs yearly fees,” Loh said. “To the extent possible, you want to strategize that and reduce the number of Class III submissions that you have.”


For Class III devices, clinical evaluation reports are scrutinized rigorously. (TGA recently released a draft clinical evaluation document that is 186 pages long.) TGA will also review the literature searches you performed, to determine whether they can replicate those literature searches. Notified body auditors also perform those searches, but not to the depth and degree that TGA does.

Upon successful review, TGA would provide an ARTG (Australian Register of Therapeutic Goods) listing number. All medical devices must have these numbers before they can be marketed in Australia.

Overall, for Class II and lower devices, the entire process from submission to acceptance is on average between two to three months in length. Compared to other nations in the Asia-Pacific region, that’s a relatively quick approval process. For example, CFDA requires home nation approval, device testing by a CFDA lab and clinical evidence testing, and Class II device approval can take 12 to 20 months. Class II devices in South Korea will usually take four to six months.

Maintaining your ARTG listing is also fairly simple. The listing is valid for one year, and the renewal process involves paying the listing fee and keeping your most current CE Marking up-to-date in TGA’s system. In India, for comparison, device registration is valid for three years, but the process for maintaining that registration needs to be started at least one year in advance.

Loh expressed the critical importance for a manufacturer to have a reputable notified body as its CE Mark issuer. In concordance with the EU’s new Medical Device Regulations, all notified bodies will need to be re-certified. Following several scandals wherein notifying bodies were competing to approve products, Loh believes that the number of Notified Bodies will decrease. Notified bodies were already decreasing in Europe, prior to the new regulations. In 2012, there were 70 notified bodies. By Fall 2013, there were 45. Some experts expect the number of notified bodies to continue to drop, but will remain above 12. Loh recommends that companies solely utilize well-known, reputable bodies.

Rob Packard, a regulatory consultant with 20 years of experience, explained his process for selecting a notified body in a 2013 BONEZONE article. “I make a short list and then request multiple quotes. Typically one or more of the NBs will do such a poor job of customer service during the quoting process that the list will be cut down to two or three, quickly. I will only recommend one of the 15 registrars recognized for CMDCAS, and then I will use other factors to cut that list down to five or six candidates for my short list. Factors I consider are the number of technical reviewers for orthopaedics, the target countries in marketing in Europe and the client’s previous experience with NBs,” he said.

Finally, Loh recommends that manufacturers take advantage of the Australian Orthopedic Association National Joint Replacement Registry (AOANJRR), which collects data from ARTG-listed devices. The registry also includes data on spinal disc replacement. AOA’s objective is to improve the quality of care for Australians undergoing joint replacement surgery. The data it collects includes information like the number of males and females who received a spinal ball trough, or a look at who received various spinal disc replacements by age group. It also includes more specific research, like most-used segment prostheses in Primary Spinal Segment Replacement. The entire database is open to the public and can be accessed here.

Of note, China and South Korea have publically-available databases that provide fertile research ground. China’s database can be accessed here and South Korea’s can be accessed here. If you’re interested in approval in India, you can access the meeting minutes of their orthopaedic committee, which provide valuable insight into why devices receive approval—or not.

Conclusion

For companies that already have their CE Marking, device approval in Australia is a logical next step. The TGA’s reliance on many of the same standards as the EU’s notified bodies, in addition to their acceptance and consideration of CE Marks, makes the process for approval smooth and efficient for international companies. It’s also appealing to know that you can conduct the entire registration process electronically, for some Class II devices.

Of the four major markets in the Asia-Pacific region that Loh examined, the nation with the easiest path to device approval is Australia. If that market fits your device, and you intend to expand your company, it would behoove you to consider the land down under.

Questions about this article? This email address is being protected from spambots. You need JavaScript enabled to view it.