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), 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: Therapeutic Goods Administration (TGA)

Validity of License: Registration does not expire if the annual fee is paid

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

Submission Format: Electronic submission at TBS

Language: English

TGA Medical Device Classification

Medical Device classification, 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.

TGA Medical Device Classification other than IVDs Class

Risk

I

Low Risk

 IIa

Low Moderate Risk

IIb

Moderate – High Risk

III

High Risk

AIMD

High Risk

TGA IVD Classification

Risk

1

No public health risk or low personal risk

2

Low public health risk or moderate personal risk

3

Moderate public health risk or high personal risk

4

High public health risk

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.

Australia Medical Device Registration

Medical Device Registration, Australia procedure and ARTG Listing procedure in Australia varies with the class of the device.

Class I devices: For Class I non-sterile, non-measuring devices, manufacturer’s declaration of conformity must be submitted with the application, for the inclusion in the ARTG database. 

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 ). Audits are mandatory for Class III (AIMD – Active Implantable Medical Devices), specified Class IIb medical devices, Class 4 IVDs and no. of specified Class 3 IVDs; unless supported by a conformity assessment from TGA or issued under the European MDR/IVDR. Post that the ARTG number will be issued. This will be accompanied by the 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

Risk

Device Class

QMS Audit

Regulatory Pathway

TGA Timelines

Low

Class I

NA

ARTG Listing

Immediate

Low-moderate

Class IIa

ISO 13485:2016 compliance (MDSAP)

ARTG Listing

230-250 TGA working days

Moderate-high

Class IIb

ISO 13485:2016 (MDSAP)

ARTG Listing

230-250 TGA working days

High

Class III

ISO 13485:2016 (MDSAP)

ARTG Listing

230-250 TGA working days

Expertise

Freyr Expertise

  • Australian Sponsor support
  • E-Business System account creation and management
  • Conformity Assessment 
  • MDSAP Certification support including, internal audits, mock-audits, training etc.
  • ARTG Listing
  • Labeling support
  • Distributor identification and qualification 
  • Post Marketing Surveillance 
  • Post Approval Change Management
  • License renewal and transfer 
  • Submission and liaising services with the TGA