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Medical Devices Regulatory Support in Australia

Overview

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

Medical Devices – Key Aspects to be Considered 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, if 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

TGA Medical Device classification in Australia is like 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 (04) classes in the ascending order of their risk, which are Classes I, IIa, Iib, and III. The Australian Medical Device classification system 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

TGA IVD Classification 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 a 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 representatives for the product to be marketed in Australia and to register it with the TGA.

Medical Device Registration in Australia

The procedure of Medical Device Registration in Australia and the ARTG listing method varies with the class of the device.

Class I Device

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

Other Class Devices

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

Process Flow

Post-approval Device Product Maintenance & Compliance

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

  • Post-approval change management - Modifications to existing Medical Device approvals, such as the addition of new variants, accessories, and the 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 the quality and safety needed for approval. Freyr’s support experts keenly observe the Regulatory updates and keep the clients informed about steps to be taken for product compliance with the prevalent standards in the Australian medical device regulations.

Summary

Risk

Device Class

QMS Audit

Regulatory Pathway

TGA Timeline

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

 

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
  • In-depth knowledge of the Australian Medical Device regulations

Location

903/50 Clarence St,
Sydney NSW 2000
(9th level of building 50)

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