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Australian Medical Device Regulatory Authority

The TGA (Therapeutic Goods Administration) is the regulatory authority for medical devices in Australia. As the supervisory body for therapeutic goods (including medicines, medical devices, genetic technologies, and blood products), it is specifically responsible for managing the entire process of importing, exporting, manufacturing, supplying, and marketing therapeutic goods.

Regulatory Authority Website: https://www.tga.gov.au/

Database link: https://www.tga.gov.au/resources/artg

Regulatory Framework

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002

Risk Level Classification

Registration Requirements

When submitting applications for TGA registration of medical devices and IVD products, compliant manufacturer evidence must be provided. Currently, the TGA recognizes the following manufacturer evidence and registration approval documents:

① Conformity Assessment Certificates issued in Australia (AU CAB/COC)

② MDSAP Certificate | ISO 13485 Certificate

③ Recognized overseas registration approval documents:

• AU CAB CERTIFICATE

• TGA CONFORMITY ASSESSMENT CERTIFICATE

• EC CERTIFICATE

• HEALTH CANADA LICENCE

• JAPAN PRE-MARKET CERTIFICATION/APPROVAL

• SINGAPORE HSA CERTIFICATE

• MRA CERTIFICATE

• US FDA 510(k) DETERMINATION

• US FDA DE NOVO ORDER

• US FDA PREMARKET APPROVAL

Registration Language

English.

Australian Sponsor

The Australian medical device sponsor (SPONSOR) is responsible for applying to the TGA to list medical devices in the Australian Register of Therapeutic Goods (ARTG). In the Australian market, medical devices must be listed in the ARTG before they can be legally sold.

SPONSOR Eligibility Requirements: The SPONSOR must be a resident of Australia, or an entity incorporated in Australia that actually conducts business there, and the company’s designated representative must reside in Australia.

Post-market Legal Responsibilities (After Device Inclusion in the ARTG): The SPONSOR must cooperate with the TGA to complete post-market surveillance activities and fulfill ongoing reporting and record-keeping obligations, specifically including:

• Promptly reporting product adverse events to the TGA

• Promptly reporting regulatory actions taken by overseas regulatory authorities regarding the product to the TGA

• Submitting relevant investigation results conducted by the manufacturer (e.g., follow-up clinical studies, adverse event review reports, etc.)

• Obtaining all compliance documentation required by the TGA from the manufacturer and properly maintaining product distribution records

The TGA will enter all received adverse event reports and product complaints into a dedicated database. An internal team of clinicians and scientists will conduct professional risk assessments and, if necessary, initiate product investigations. During the investigation process, the TGA may seek advice from external experts as needed.

Registration Flow and Cycle

1. Confirm whether the product is a medical device (Therapeutic Goods) in accordance with Section 41BDA of the Therapeutic Goods Act 1989

2.Appoint a Sponsor

3.Determine the risk classification of the medical device or IVD product

4.The Sponsor submits manufacturer evidence via the EBS portal

5.TGA approves the submitted manufacturer evidence

6.The Sponsor lodges the product registration application through the EBS portal

7.TGA conducts application review, with three potential outcomes:

Outcome 1: Direct approval of the registration application
Outcome 2: TGA issues feedback requesting supplementary documentationAfter supplementary documents are submitted for re-review, two results may occur:a) Application approvedb) Application rejected with official justifications provided

Official Fee

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Official Fees: https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf

FAQ

Q: How long does the registration of medical device in TGA?

A: The time of registration of medical device in TGA is related to many factors, product risk level、registration path、product technical documentation level、feedback speed of Sponsor and the workload of TGA officials and so on will jointly determine the registration cycle of the product.
① Registration of non-sterile/non-measured/non-reusable Class I products is expected to be approved within 1 month of submission of product documentation.
② Is/Im/Ir/IIa/IIb products can be approved within two months after submission, based on the approval of recognized country registration. If there is no approval of recognized country registration, it is necessary to initiate an application for review to TGA or a TGA accredited review body. In this way, it is necessary to consider whether the product has completed all tests as required, whether clinical tests have been completed or certificates have been obtained to assess the registration cycle.
③ In addition, even if the registration has been approved by a recognized country, the application may be fully reviewed by TGA, and if TGA issues a notice requesting a full review, the review cycle may vary from several months to one year depending on TGA's approval decision.
④ Class 3 medical devices and Class 4 in vitro diagnostic reagents have the longest registration application cycle, and TGA will conduct a comprehensive review of the product, and only through a comprehensive review of the product will be approved and obtained ARTG certificate.

Q: Does it need a QMS certificate for TGA registration of medical devices?

A: If the medical device has a recognized country registration approval certificate or proof in the TGA registration, it does not need to issue a separate QMS certificate, TGA recognizes the ISO 13485 certificate and MDSAP certificate issued by a specific body, and if the TGA requires the manufacturer to supplement the QMS evidence during the audit process, the manufacturer also needs to meet the requirements of TGA.

Q: After the registration of a medical device, can we change the Sponsor if we find that the Sponsor does not cooperate with the business?

A: Yes, TGA allows manufacturers to change Sponsors with the consent of the current Sponsor, and Wiselink AU can assist with the change.

Q: Can a product be registered by multiple sponsors at the same time?

A: Yes, but Wiselink does not recommend doing so. The manufacturer can select an independent third-party Sponsor to hold the ARTG certificate. The independent third-party Sponsor will not interfere with the manufacturer's sales business, and will actively cooperate with the manufacturer's goods import. Medical device products can be distributed to multiple dealers at the same time.

Q: Can medical device products make a registration change after the completion of registration?

A: If the change content of the medical device product meets the scope allowed by TGA, Sponsor can submit the change application to TGA, and the product can be put into the Australian market after being approved by TGA.

九、TGA Certificate template

Can medical device products undergo registration changes after completing registration?

Can a product be registered by multiple Sponsors at the same time?

Can the Sponsor be replaced if the Sponsor is uncooperative in business operations after a medical device has completed registration?

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