Medical Devices Regulatory Services
in Australia

Overview

Medical Devices in Australia are regulated by Therapeutic Goods Administration (TGA). The Medical Devices and IVDs shall be listed in Australian Register of Therapeutic Goods (ARTG), before they are marketed in Australia.

Regulatory Authority: Therapeutic Goods Administration (TGA)

Regulation: Australian Therapeutic Goods (Medical Devices) Regulations 2002

Regulatory Pathway: ARTG inclusion

Authorized Representative: TGA Australia sponsor

QMS Requirement: ISO 13485:2016 certification

Assessment of Technical Data: Conformity Assessment Body (CAB)

Validity of License: Registrations do not expire as long as no changes are made to the device

Labeling Requirements: Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002

Submission Format: Electronic submission at TBS

Language: English

Medical Device Classification in Australia

Medical Device classification in Australia is similar to the EU classification rules and criteria. There are different classifications for Medical Devices and IVDs. Based on the risk to the human body Medical Devices are divided into four classes in the ascending order of their risk which is class I, IIa, IIb, and III.  The classification system in Australia is as per the Australian Therapeutic Goods (Medical Devices) Regulations 2002.

Medical Device Authorized Representative/Sponsor

The Authorized Representative is termed as Sponsor and acts as a liaison between the manufacturer  and the Therapeutic Goods Administration (TGA) as mentioned in the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. The sponsors will be the Regulatory representative for the product to be marketed in Australia and to register it with the TGA.

Medical Device Registration in Australia

The Registration procedure and ARTG Listing procedure in Australia varies with the class of the device.

Class I Device The device can be directly listed in ARTG database. The technical file shall be maintained and updated from time to time and is not required to be submitted to TGA for device listing.  

Other Class Devices

The sponsor must submit Australian Declaration of conformity, QMS certification (ISO 13485:2016 or MDSAP), manufacturing evidence (e.g., CE certificate) in TGA Business Service (TBS). TGA will review the technical file for the level 2 audit application (mandatory for class III and some class IIb devices) before issuing approval and post that the ARTG number will be issued. This will be accompanied by ARTG inclusion certificate, which will be included in the ARTG database and TGA website.

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device life-cycle Management, including post approval activities, such as –

• Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
• Maintenance of approvals and registration through timely payment of administrative and registration fees
• Renewal of licenses

With a regional office in Australia and with a professional team to provide Regulatory support, Freyr supports manufacturers in maintaining quality and safety needed for approval. Freyr’s intelligence experts keenly observe Regulatory updates and keep the clients informed about steps to be taken for product compliance with prevalent standards.

Summary