1.
Australia
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 08/2016. EmergoGroup.com/australia
Determine classification using Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If your device
has European CE Marking the classification will likely be the same. A CE Marking certificate from a Notified Body is generally
accepted by the Therapeutic Goods Administration (TGA) as part of your registration.
If you do not have a local presence in Australia, appoint an Australian Sponsor. The Sponsor facilitates your device registration
and acts as the liaison between the manufacturer and the TGA. The Sponsor’s name must appear on your device and labeling.
Have current Technical File or Design Dossier and Australian Declaration of Conformity ready for submission.
Sponsor submits Medical Device Application in TBS System. The Application includes Intended Purpose statement, classification
and Global Medical Device Nomenclature (GMDN) code. Pay application fee.
The TGA will approve or reject your application. If approved by TGA, an Australian Register of Therapeutic Goods (ARTG) listing
number will be issued (ARTG Certificate of Inclusion) and your listing will be included in the ARTG database on the TGA website.
You may now begin marketing your device in Australia. Registrations do not expire as long as you do not make changes to the
device that would invalidate the ARTG listing, a current CE Marking certificate (if applicable) is on file with the TGA, and the
annual ARTG listing fee is paid.
Sponsor submits Manufacturer’s Evidence (e.g. CE Marking certificate) in TGA Business Services (TBS)
system for TGA’s review and acceptance.
TGA will review* sections of your Design Dossier
as part of a Level 2 application audit.
Class I
Non-sterile;
Non-Measuring
Class IIaClass I
Sterile; Measuring
Class IIb Class III
5004-0816
The Regulatory Process for Medical Devices
IMPORTANT: This chart demonstrates the route to compliance in Australia for devices that already have CE Marking and which do not include animal tissue, human blood/plasma derivatives, or medicinal substances.
*A Level 2 application audit is required for all Class III devices, but only a small percentage of Class IIb devices.
This is a simplified overview of the process. The TGA may choose to audit your submission and request more documents, which will add time to your approval.

2.
Australia
Notes
1. The TGA generally recognizes European CE Marking; most non-Australian companies have CE Marking certification before entering the Australian market.
The time frames indicated above assume your device has CE Marking but does not contain animal tissue, human blood/plasma derivatives, or medicinal
substances, or employ entirely novel technology. However, the TGA reserves the right to perform an Application Audit on any submission, regardless
of classification or CE Marking status. Your length of approval will depend on the quality and completeness of your technical documentation and how
much time you take to address additional information requests from TGA after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS
SHOWN ABOVE.
2. Once an ARTG listing is obtained it is valid indefinitely, as long as the TGA annual ARTG listing fee is paid (see note 3), and there are no changes to the
device that would invalidate the ARTG listing, i.e. change in device classification, GMDN code, or indications for use. However, the manufacturer/device
must be kept in compliance, with a current copy of the CE Marking certificate (if applicable) on file with the TGA.
3. Failure to pay renewal fees will result in the ARTG listing being revoked. Please consult with your Sponsor or regulatory expert well before this suggested
time to avoid any lapse in your registration.
4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who
were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other
markets are compared.
5. Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing,
in-country representation and submission preparation consulting. Costs assume you already have approval for your device in Europe. Does not include cost
of implementing, auditing, or updating a quality management system compliant with ISO 13485, if applicable.
EmergoGroup.com/australia
Device classification
in Australia
Class I
Non-sterile;
Non-Measuring
Class I
Sterile or Measuring
Class IIa Class IIb Class III
How long you should
expect to wait after
submission until
approval is granted.1
<1 month 2-3 months 2-3 months 2-3 months 7-14 months
Validity period for
device registrations/
ARTG listing.2
Does not expire Does not expire Does not expire Does not expire Does not expire
Registration renewal
should be started this
far in advance.3
1 month 1 month 1 month 1 month 1 month
Complexity of the
registration process
for this classification.4
Overall cost of gaining
regulatory approval.5
5004-0816
© 2016 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 08/2016.
Time, Cost, and Complexity of Registration
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
Low High
* Class I devices that are NOT provided sterile and which do NOT have a measuring function are automatically accepted onto the ARTG, but are still registered by the Sponsor. As such you will be able to sell your
product in Australia within one week of submitting the necessary paperwork to the TGA.
This is a simplified overview of the process. The TGA may choose to audit your submission and request more documents, which will add time to your approval.