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.

Class of Medical Devices other than IVDs Class

Risk

I

Low Risk

 IIa

Low Moderate Risk

IIb

Moderate – High Risk

III

High Risk

AIMD

High Risk

IVD or In-house IVD Medical Devices

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.

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 application audit (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

Medical Devices Regulatory Services in Australia 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.

S. No.

Risk

Device Class

QMS Audit

Regulatory Pathway

TGA Timelines

1

Low

Class I

NA

ARTG Listing

Immediate

2

Low-moderate

Class IIa

ISO 13485:2016 compliance (MDSAP)

ARTG Listing

230-250 TGA working days

3

Moderate-high

Class IIb

ISO 13485:2016 (MDSAP)

ARTG Listing

230-250 TGA working days

4

High

Class III

ISO 13485:2016

(MDSAP)

ARTG Listing

230-250 TGA working days

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
  • Post Marketing Surveillance
  • Post Approval Change Management
  • License Renewal and Transfer
  • Submission and Liaising Services with the TGA