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 TG(MD)R Sch3. As of January 1st, 2019, ISO 13485:2016:2003 (which was formally recognized by TGA as a standard for the manufacture of Medical Devices that require a quality management system for conformity assessment) was superseded by ISO 13485:2016. Australia is among the MDSAP (Medical Device Single Audit Program) participants, along with the United States, Canada, Japan and Brazil.
Medical Devices and IVDs are subject to registration, which means including them 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.
Timeframe 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.
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.
Labelling and documentation language
Documentation and labelling must be provided in English. The Sponsor’s name and information must be included in the product labelling.
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 licences.
