Medical Device Registration and Approval in Australia
General country-specific regulatory information is provided on this page for medical device registration and approval in Australia .
Last updated on February 4th, 2022.
Medical Device Regulations and Classification in Australia
REGULATORY AUTHORITY: Therapeutic Goods Administration (TGA)
CLASSIFICATION SYSTEM: Medical Devices: I/Is – sterile/Im – incorporating a measuring function/IIa/IIb/III/AIMD IVDs: 1/2/3/4
TIMEFRAME: Medical Devices and IVDs (based on experience) Approximately 1-2 months to complete both the conformity assessment and ARTG inclusion, except for Class I medical devices (non-measuring, non-sterile), Class 1 IVDs, and Class 1,2,3 in-house IVDs that are exempted from conformity assessment.
SPECIAL REQUIREMENTS: On-site audits are necessary for all manufacturers (both domestic and foreign manufacturing sites) applying for a TGA Conformity Assessment Certificate. However, the audits might not be required for the manufacturer that has been audited by EU Notified Bodies, MDSAP – Medical Devices Single Audit Program, FDA, Health Canada, etc. Local testing is only required for HIV testing devices.
LOCAL FEES (New Application)
Conformity Assessment: varies depending on type of assessment from USD 18,000 to USD 46,000
- Class I (non-sterile & measuring device): USD 450
- Class I (sterile & measuring device)/Class IIa/Class IIb: USD 800
- Class III/AIMD: USD 1,050
- Application Audit (if applicable): varies depending on type of application audit from USD 3,000 to USD 5,500
In-vitro Diagnostics (IVDs)
Conformity Assessment: varies depending on type of assessment from USD 13,000 to USD 50,000
ARTG Inclusion (all classes): USD 800
Technical File Review (TFR) – if applicable:
- Class 1/2/3: USD 5,500
- Class 4 (in-house IVDs): USD 50,000
- Class 4 (in-house immunohematology reagent IVD): USD 12,100
LOCAL FEES (Manufacturer): If on-site audits are applicable, there will be surveillance inspections fees (the amount varies depending on type of QMS inspection and other additional fees such as assessor fee, travel expenses, etc.).
LICENSE VALIDITY: Conformity assessment certificate: 5 years ARTG inclusion certificate: no validity; however, to maintain a medical device in the ARTG, annual fees will be charged depending on the classification of the device
LICENSE TRANSFER: License transfer is possible. Both new and former sponsor must complete a notification form after the transfer has occurred. No fee is required.
AUTHORIZED REPRESENTATIVE: Foreign manufacturer must designate local authorized representative who will be known as “Sponsor”.
ADDITIONAL INFORMATION: From the 1st of October and 4th of December 2020, applicants of class I medical devices (non-measuring, non-sterile) and class 1 IVDs, respectively, need to provide a manufacturer’s Declaration of Conformity with their application to include the device in the ARTG, rather than simply holding it at the time they apply for inclusion. If TGA is not satisfied with the application, TGA will select the application for non-mandatory audit but if TGA is satisfied, TGA will include the device in the ARTG within 4 working days. There are several ways to expedite the conformity assessment/ARTG inclusion process.
- Priority Review Designation – through this process, the device will be allocated “front-of-queue” priority throughout the relevant assessment process. This is applicable for devices intended for serious condition in which the devices’ need in Australia is currently unmet and/or the devices could bring a breakthrough technology.
- Abridged Procedure – some overseas evidence (such as certificates issued by EU notified bodies, MDSAP, FDA, Health Canada, MHLW, etc.) can be used to support the application for conformity assessment or ARTG inclusion.
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