There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.

However there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.

In such circumstances sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle.

Application form

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

How to access a pdf or Word document

• Application for consent to import, supply or export a medical device that does not comply with the essential principles (pdf,118kb)
• Application for consent to import, supply or export a medical device that does not comply with the essential principles (docx,150kb)