September 20, 2021
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has clarified changes to conformity assessment certification and auditing processes for some higher-risk and implantable medical devices and in vitro diagnostic devices that have already obtained European CE Marking.
The TGA’s regulatory amendments target certain Class III and active implantable medical as well as Class 4 IVD devices, for which only TGA-issued Conformity Assessment Certificates (CACs) had previously been accepted for Australian market entry applications. Specific devices covered by the TGA amendments include:
- Medical devices whose components include non-viable tissues of animal origin;
- Medical devices containing tissues, cells, microbial- or recombinant-based substances intended for use in or on the human body;
- Medical devices featuring stable derivatives of human blood or plasma that act upon the human body in an ancillary fashion;
- Class 4 IVD devices.
TGA allowances for certain CE Marked medical devices and IVDs
Now, Australia market applicants whose Class III or active implantable medical devices fall under the categories identified in the TGA amendments may instead submit conformity assessment documents issued by European Notified Bodies for CE Marking under either the European Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), Medical Devices Directive 93/42/EEC (MDD) or Medical Devices Regulation (MDR).
For Class 4 IVD manufacturers, TGA will accept conformity assessments from Notified Bodies under the European In-vitro Diagnostic Devices Directive 98/79/EC (IVDD) or In-vitro Diagnostic Medical Devices Regulation (IVDR).
Thus, Australian market applicants of medical devices and IVDs identified under these new amendments face fewer steps in terms of meeting TGA submission requirements if they have already obtained CE Marking for their products.