Class IIa & Class IIb Medical Device Information

Essential Information for Class IIa & Class IIb Medical Device Listings 

Navigating the Latest TGA Amendments: Essential Information for Class IIa & Class IIb Medical Device Listings

Ever since the shakeup of the European Union (EU) Medical Device Regulations (MDR) in 2017, the Therapeutic Goods Administration (TGA) have adjusted their dependence on utilising the EU as their basis for listing on the Australian Register of Therapeutic Goods (ARTG). It was in 2018/19 that the TGA made the decision to expand the overseas regulators to include those as part of the Medical Device Single Audit Program (MDSAP) program specifically: Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States Food and Drug Administration (FDA); and in 2022 the addition of the Health Sciences Authority (HSA) of Singapore.

Market Authorisation from Comparable Overseas Regulators

To account for the regulatory differences between countries, the TGA compiled a determination to describe the information that must accompany an application for inclusion to the ARTG. The amount of information expected increases as the classification (or risk) of the device increases, for example a Class Is device only requires a MDSAP certificate, whilst a Class IIa device requires an MDSAP certificate AND a 510k summary (using US as the overseas regulator).

Changes to the EU Additional Information Required

Class IIa & Class IIb Medical Devices

The TGA has just released a new ruling revising an EU additional information requirement (specifically the EU technical documentation assessment certificate) required for Class IIa and Class IIb devices. Upon review of current practices, the TGA identified that such a certificate is not issued for Class IIa or certain Class IIb medical devices in the EU.

Therefore, to correct the unintended misalignment with current practice under the EU MDR the TGA have:

  • removed the requirement for Class IIa and certain Class IIb medical devices to provide such documentation
  • clarified that such an application for inclusion of a Class IIb relevant implantable medical device must be supported by an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation.

Or in tabulated form –

Device ClassificationRegulators/ ApprovalsManufacturer Evidence 
(QMS Certificate)
Class IIa EU MDR Annex IX, Chapter I (QMS) Section 4, Annex IX (Assessment of Technical Documentation)No longer required 
Class IIb EU MDR Annex IX, Chapter I (QMS)Annex IX, Chapter II (Assessment of Technical Documentation) (based on a representative sample, BUT Class IIb implantable, for each device, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.Only required for a relevant implantable medical device 
Where the definition of “relevant implantable medical device” now incorporates the exclusion of sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. 

How can PharmOut Help?

PharmOut can help you with Medical Device Registration with the TGA in Australia, providing regulatory compliance services for medical device product classification, preparation of technical files, and troubleshooting compliance problems.