This updated version is now in line with the Department's Good Guidance Practices and includes the following key changes: the removal of information specific to Investigational Testing Authorizations (this information is now available in Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary); additional information regarding Private Label Licence Applications (new and amendments); and, a streamlined appeal process with the removal of the requirement for a letter of intent to appeal.
This guidance document applies to the following application types:
Licence Applications for Class II, III and IV medical devices
Licence Amendments for Class II medical devices, and Licence Amendments (significant changes) for Class III and IV medical devices, and
Licence Amendment Minor Changes (Faxbacks) for Class II, III and IV medical devices
New and Amendment Medical Device Licence Applications for Private Labels