Australia TGA Approval: Leveraging CE Certification and FDA Clearance

January 2, 2024

7 mins

Home » Resources & News » Australia TGA Approval: Leveraging CE Certification and FDA Clearance

Australia has long been considered a market where device CE certification has presented the easiest pathway to entry for overseas device manufacturers. While CE certification (complemented by conformity with Australian-specific requirements) continues to be a viable pathway for manufacturers to enter the Australian market, other options are available for manufacturers that don’t require undergoing direct Therapeutic Goods Administration (TGA) conformity assessment. It has been over five years since the Australian TGA published the Therapeutic Goods (Overseas Regulators) Determination 2018 under which alternatives were established by the regulatory authority. While overseas approvals and assessments may also be used to abridge TGA conformity assessment, in this article we compare the pathways for leveraging CE certification and FDA clearance for obtaining device inclusion on the Australian Register of Therapeutic Goods (ARTG).

Requirements for ARTG Inclusion for Australia TGA Approval

Navigating the intricate process of gaining approval for medical devices on the ARTG involves adherence to specific inclusion requirements. These requirements encompass two primary steps, beginning with the submission of Manufacturer’s Evidence (ME) to the Therapeutic Goods Administration (TGA). ME serves as a comprehensive record, illustrating a manufacturer’s compliance with conformity assessment procedures tailored to each medical device category. This evidence substantiates subsequent submissions for ARTG inclusion and plays a pivotal role in the regulatory journey. Additionally, depending on the device classification, manufacturers must ensure alignment with stringent criteria outlined by the TGA.

Submission of Manufacturer’s Evidence to the TGA

Manufacturer’s Evidence (ME) is evidence (a record) that demonstrates a manufacturer has applied appropriate conformity assessment procedures to a specific kind of medical device.

In the case of self-certified devices, this evidence is used to support every submission that a manufacturer makes to include a device on the ARTG which is covered by the scope of the ME submitted. This ME is linked to all subsequent applications for these devices for ARTG inclusion.

In the case of self-certified devices (Class I non-sterile, non-measuring, Class 1 IVD, Class I (export only) and Class 1 IVD (export only), no ME is necessary, however (as is the case for all manufacturers) their manufacturers must still prepare a TGA Declaration of Conformity (Non-IVD DoC templates are available from the TGA here, while IVD DoC templates are available here).

There are no fees for submission of ME and the TGA’s target timeframe to process ME applications is 15 working days.

Submission of Application for ARTG Inclusion

Upon TGA acceptance of your ME, the Australian Sponsor then applies to ARTG inclusion for devices of the ‘same kind’. Devices are taken to be of the ‘same kind’ if they have the following characteristics:

- - Same Australian Sponsor
  - Same manufacturer
  - Same classification
  - The same Global Medical Device Nomenclature (GMDN) code
  - For Class III, Class Active Implantable Medical Devices (AIMDs), and Class 4 IVDs (other than an immunohematology reagent that is a Class 4 IVD), the same unique product identified (UPI)

The Australian Sponsor will complete and submit this application through their e-Business account and, depending upon device classification, attach certain information to pass the TGA’s preliminary assessment.

Leveraging CE Certification for Australia TGA Approval

This is the pathway most commonly chosen. One of the primary drivers for foreign manufacturers historically leveraging CE certification for their devices is the significant parallels and overlap between Australian and EU regulatory requirements. This alignment is particularly notable in non-IVD medical devices.

Key Similarities:

- - Device classification system: While IVDs saw this alignment only after the publication of the EU IVDR, other devices shared similarities.
  - Conformity assessment-based approach: Both regions emphasize a conformity assessment-based approach, including the preparation of Declarations of Conformity.
  - Australian essential principles vs. EU essential requirements: The resemblance between the Australian Essential Principles and EU Essential Requirements is striking, with ongoing efforts by the TGA to align with EU MDR/IVDR standards.
  - Technical documentation obligations: Manufacturers in both regions are obligated to maintain comprehensive technical documentation, including clinical evaluation records for non-IVD medical devices.

Certificate Process

When leveraging CE certification, the EC certificate demonstrating that the manufacturer’s QMS has undergone assessment (e.g. MDD Full QA (Annex II) EC Certificate or MDR Annex IX, Chapter I certificate) is presented as ME while for high-risk devices MDD EC certificates for type or design examination (or MDR Assessment of Technical Documentation certificates) are typically attached to applications for ARTG inclusion as evidence of product conformity assessment.

Benefits and Challenges

The benefits of leveraging CE certification are largely related to the similarities between the Australian and EU regulatory requirements. This is particularly evident where the TGA flags an application for ARTG inclusion for an audit. In such scenarios, the manufacturer’s Australian Sponsor will need to provide the TGA with additional evidence of conformity with Australian regulatory requirements which commonly includes the clinical evaluation report (for medical devices), performance evaluation report (for IVDs), risk management file, and device labeling, as well as any other evidence the TGA deems necessary for the audit.

Leveraging FDA Clearance for Australia TGA Approval

In the case of manufacturers who hold FDA 510(k)s (or De Novo Decision) for their devices, a copy of the 510(k) summary (or De Novo Decision Summary) is attached to the application for ARTG inclusion as it is an acceptable form of product assessment for Class IIa and IIb medical devices, and Class 2 and 3 IVDs.

However, when leveraging FDA 510(k)s (or De Novo Decisions) for Australian registration, the only form of ME accepted by the TGA is an MDSAP Certificate (and Report) which complies with the following requirements:

- - The certificate is issued to the manufacturer stated on the labeling and instructions for use as the manufacturer of the kind of device for which the application for inclusion in the ARTG is submitted.
  - The Australian regulatory requirements must have been covered in the MDSAP audit (as indicated in the MDSAP Certificate (and Report)) and the manufacturer found to comply with relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.

Regulatory Challenges and Risks

Manufacturers (particularly US-based manufacturers) who are not leveraging MDSAP certification for marketing authorizations in other jurisdictions (e.g. Brazil, Canada, or Japan) therefore typically don’t end up leveraging US marketing authorization due to the small size of the Australian market.

The major risk for manufacturers looking to leverage FDA clearance for inclusion on the ARTG is where the application is flagged for a TGA audit. As there is not as much overlap or similarity between the US and Australian regulatory frameworks (unlike the case with the EU regulatory framework), foreign manufacturers can particularly face ensuring that it can provide the following documentation promptly when requested by the TGA:

- Evidence of conformity with clinical evidence under Essential Principle 14 (applicable to both medical devices and IVDs) which is directly related to Regulation 3.11 that establishes the requirement for clinical evaluation procedures to be applied to devices (unless exempt).
- Essential Principles Checklist demonstrating the objective evidence and methods applied for conformity with those Essential Principles (under Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002) applicable to the subject device and justification for non-applicable Essential Principles.

Therefore, while the TGA has opened up the possibility of leveraging FDA marketing clearance for the inclusion of devices on the ARTG, there are still some barriers to widespread adoption.

Learn More About How to Optimize Australian Medical Device Approval with MedEnvoy

This article provides an overview of different routes for manufacturers to obtain medical device approval for their devices in Australia, however, if have any questions regarding Australian medical device registration, or require an Australian Sponsor, get in touch. For more information about our regulatory experts click here.