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
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 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 the 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 the 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 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 life-cycle Management, including post-approval activities, such as –
- Post-approval change management - Modifications to existing Medical Device approvals such as the 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 the quality and safety needed for approval. Freyr’s Support 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 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
