Overseas regulatory evidence options for a medical device application

Specific evidence and documentation, issued by specific overseas regulators and assessment bodies, can be used for applications for inclusion of medical devices in the ARTG.

The documentation should be issued by an overseas regulator or assessment body for the same medical device you are applying to have included in the ARTG. The device must:

• have the same design and intended purpose
• be intended for the same indications.

The guidance document Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs) provides an overview of how specific overseas assessments and approvals can be used. 

Refer to Table 2 for details of the information that must accompany ARTG inclusion applications for the purpose of passing preliminary assessment.