Regulatory Open Forum

Say I have a class IIa device (Device A) and I submit an application to the TGA to list this kind of device on the ARTG using Device A's cleared FDA 510(k) and the manufacturer's MDSAP certificate as foreign evidence. The ARTG application is approved and Device A is now available to supply.

A few years later, we develop Device B which is the same kind of device as Device A (as defined by the TGA) and want to supply it under this same ARTG listing. My questions are:

1. Can and should each device have a separate Australian Declaration of Conformity?
2. Does the class IIa evidence for Device B need to be the same as the original submission (FDA 510(k) and MDSAP) or would any equivalent evidence (e.g. EC certificate) be acceptable?

TGA doesn't have any requirement for number of DoCs for each ARTG or each kind of devices. There should be no problem to have one DoC or multiple DoCs for an ARTG entry. Just make sure that you have DoC for your ARTGs.

Each ARTG is supported by a QMS certificate as manufacturer's evidence and the evidence is stated on ARTG certificate. Your Device B must have the same evidence with Device A to be included into the same existing ARTG.

If Device B has a different evidence, you need to apply for a new ARTG for Device B.

Say I have a class IIa device (Device A) and I submit an application to the TGA to list this kind of device on the ARTG using Device A's cleared FDA 510(k) and the manufacturer's MDSAP certificate as foreign evidence. The ARTG application is approved and Device A is now available to supply.

A few years later, we develop Device B which is the same kind of device as Device A (as defined by the TGA) and want to supply it under this same ARTG listing. My questions are:

1. Can and should each device have a separate Australian Declaration of Conformity?
2. Does the class IIa evidence for Device B need to be the same as the original submission (FDA 510(k) and MDSAP) or would any equivalent evidence (e.g. EC certificate) be acceptable?