Regulatory authority

Therapeutic Good Administration (TGA)


Classification

I, IIa, IIb, III


Quality System

The Australian Quality Management System requirements for medical devices are defined by Regulations.

ISO 13485:2016 is formally recognized by TGA as a standard for the manufacture of medical devices that require a quality management system for conformity assessment.

Australia is among the MDSAP (Medical Device Single Audit Program) participants, along with the United States, Canada, Japan and Brazil.


Procedure

Medical devices and IVDs are subject to registration, they need to be included on the Australian Register of Therapeutic Goods (ARTG).

Foreign manufacturers who intend to market their medical devices in Australia must appoint a Sponsor, a Local Authorized Representative responsible for submitting the documents required for the registration process to the TGA.


Applicant

Sponsor


Time frames and fees

A one-time listing fee is required to include a medical device on the ARTG, as well as yearly fees for the renewal of the ARTG registration. Fees are updated each fiscal year.

Fees and charges: summary from 1 July 2019

The TGA accepts and recognizes the CE marking, which facilitates the registration process for all medical devices already bearing this marking. However, the duration of the approval process depends on the quality and completeness of the manufacturer’s technical documentation, as well as the readiness to provide any additional information required by TGA during this time.  


Validity

To maintain the registration valid, once the device is listed in the ARTG, the Sponsor must pay an annual fee before the end of each fiscal year.


Labeling and documentation language

Documentation and labeling must be provided in English. The Sponsor’s name and information must be included in the product labeling.


Useful information

Australia’s regulatory system is very similar to the European one, thus the medical device classification system as well.  A CE Certificate of Conformity issued by a Notified Body is generally required by the TGA among the documents to be submitted for registration, allowing them to leverage prior CE marking to grant Australian device licenses.


About Research Use Only (RUO) products

RUO products are not subject to registration, they don’t need to be included on the Australian Register of Therapeutic Goods (ARTG). But they are subject to other regulations (i.e. Importation requirements) (see Australian Border Force)


Links

All documents listed below are available from the Australian Therapeutic Goods Administration (TGA).

Major Regulations:

General Guidance Documents

IVD Guidance Documents

Forms and Applications

Additional Information