Frequently Asked Questions

Over the past 10 years we have been asked many questions on how to import and distribute medical devices in Australia.

Shown below are a collection of key questions and answers.

Q. Can an overseas manufacturer directly import devices into Australia?

A. No.  It is illegal to bring medical devices into Australia unless they are restricted for personal use and do not contravene custom laws.

Q. Can an overseas manufacture be a sponsor in their own right on the ARTG?

A. Yes. If they have established a legal entity in Australia and comply with the law that one director of the company is an Australian Resident.

Q. Do you have to be an Australian Citizen to be a sponsor for the ARTG?

A. No. you need to be an Australian Resident.

Q. How do you become a sponsor?

A. Either contact me on roy@righttimebusiness.com.au  and I will send you the correct TGA paperwork, or simply go to www.tgasime.health.gov.au and download the respective paperwork.

Q. How do I find out about the responsibilities of being a sponsor?

A. Go to www.tga.gov.au and download the respective documentation.

Q. Does inclusion on the Australian Register give immediate access to the New Zealand market?

A. No.  You need to go to www.medsafe.govt.nz and make specific application to enter your device on the WAND.

Q. How do we determine the class of the device?

A. Speak with your manufacturer or go to www.tga.gov.au and download the rules and guidance documents.

Q. Do we need a GMDN code for all devices?

A. Yes and this is the responsibility of the manufacturer to issue and agree to.

Q. What do we need to include a device on to the ARTG?

A. Once you are a sponsor you need a declaration of manufacturer’s conformity to the Australian standard.  The guidelines to prepare this document can be found at www.tga.gov.au

If greater than a class I such as a class IIa or class IIb you will need a CE or EC certificate that is current. For other higher classes of devices see requirements at www.tga.gov.au

Q. How do we make and application onto the ARTG?

A. You can follow the procedure outlined within the instructions shown on the TGA website at www.tga.gov.au or email me at roy@righttimebusiness.com.au and we can assist you and act as your agent.

Q. What if we can not understand any of the requirements?

A. Simply email me at roy@righttimebusiness.com.au and we can answer initial questions, offer assistance and act as your independent agent with the TGA in Australia.