Medical Devices Registration in Australia Made Easy

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Introduction

The regulation and registration of Medical Devices and In-Vitro Devices in Australia are managed by the Therapeutic Goods Administration (TGA), which is a division of the Department of Health of Australia. To register your medical devices in Australia, the guidelines provided by the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 should be followed to understand the classification and regulations applicable to your medical device.

As per the Therapeutic Goods Act, a Medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to diagnose, monitor, prevent or treat any disease/injury/disability.

Classification of Medical Devices Registration in Australia

The classification of medical devices registration plays a crucial role in the registration process in Australia. The potential harm or risk associated with the medical device determines the review process and applicable fees. It is important to understand the classification of your medical device to ensure that the registration process is carried out accurately.

The classification of Medical devices as well as In-Vitro Diagnostics Devices in Australia is done as per the classification mentioned in Therapeutic Goods (Medical Devices) Regulations 2002.

Classification of Medical device in Australia

Medical Device Class	Potential Harm/Risk Involved
Class I	Lowest
Class I (sterile or measuring function)	Low
Class IIa	Low to Moderate
Class IIb	Moderate to High
Class III	High

Classification of In-Vitro Diagnostics device in Australia

In-Vitro Device Class	Risk Involved
Class 1	No public health risk or low personal risk
Class 2	Low public health risk or moderate personal risk
Class 3	Moderate public health risk or high personal risk
Class 4	High public health risk

Medical-Devices-Registration-in-Australia

Process for Medical Device Registration in Australia

Identify the Class of Medical Devices: To initiate medical devices registration in Australia, the classification of medical devices and the evidence for the same is submitted in the first step. The classification system, as per the risk involved in the medical device, helps manufacturers select the correct medical device class.
Appoint a TGA Sponsor: The Medical Device Manufacturer must appoint a sponsor, who will submit the documents and follow the Medical Device registration process on the behalf of Medical Device Manufacturer.
Submission of Required Documents: In the Medical Device Registration process in Australia, the Therapeutic Goods Administration (TGA) has listed various documents that shall be submitted as per the medical device class in the process for registration.
Submission of Your Application: To submit your medical device application for inclusion in the ARTG, sponsors are required to submit their application on the ARTG official website and follow the steps as per the classification of the medical device.
Payment of your Application Fees: Along with the submission of your application, the sponsor will pay the application fees for the submission of the medical device application to ARTG. If a medical device has certification or approval from overseas, it can undergo a shortened regulatory review process, provided it matches the same design, intended purposes, and indications.

Application fees payable to ARTG

Medical Device Classification	Application Fee	Estimated Review Time	Schedule
Class I (sterile/measuring)	$1,060	4 weeks	Item 1.5(e)
Class I (other)	$550	Same Day	Item 1.5(g)
Class IIa	$1,060	4 weeks	Item 1.5(d)
Class IIb	$1,060	6 weeks	Item 1.5(c)
Class III	$1,370	6 months (incl. audit)	Item 1.5(b)
AIMD	$1,370	6 months (incl. audit)	Item 1.5(a)

Prepare for Application Audit: To verify that your medical device meets the relevant legislative requirements, Application Audits are conducted by ARTG. However, for some applications, the medical device are at discretion of the delegate for the purpose of Application audit. To check your medical device is mandate for Application audit or not, you can visit Guidance for Application Audit applicability.

The Application Audit fees has to be paid apart from Application to the ARTG for conducting the application audit of your medical device. For higher-risk commodities such as Class III and AIMD, the TGA mandates Level 2 audits, which need to be completed within 20 working days of the request.

Application audit fees payable to ARTG

Type of Application Audit	Assessment Fee	Est. Review Time	Schedule 5 Part 1
Level 1: Confirmation of the sponsor’s application and proof of compliance	$3,990	2 Months	Item 1.13
Level 2: All Level 1 activities plus risk assessment, clinical evidence review, and performance and efficacy data	$7,310	6 Months	Item 1.13

Market Your Device: If your submitted application is accepted, an official email will be sent by the ARTG along with a special ARTG number for your medical/IVD device, after which the device becomes eligible for the Australian market. You can print your ARTG certificate by logging in ARTG Business service page In case, your submitted application gets rejected, you can understand the reasons for rejection on ARTG official website.

Documents Required For Medical Device Registration in Australia

Before starting the application process for registering the medical device in Australia, sponsor has to apply and get Manufacturer’s Evidence document approved by TGA.

Manufacturer’s Evidence: This document refers to as conformity assessment document or Declaration of Conformity (DoC) document that states the Manufacturers’ has applied the correct and required conformity procedure while manufacturing their kind of medical device. To obtain the Manfacturers’ Evidence Identifier number and document, sponsor has to submit the application for the same at TGA Business Portal.

Supporting documents are required along with Manufacturer’s Evidence:

A conformity assessment certificate issued by the overseas notified body.
Clinical Evidence of your medical device containing all the clinical data files, reports, and other related files.
Product information summarizing all the product details like the class of medical device, intended use of Medical device, Instructions for use (IFU), Labelling information and other relating information.
An Application copy submitted to TGA for inclusion of medical device in the ARTG.

For further detailed information of applicability of documents depending on class of your medical device, you can visit Guidance for Applicable documents.

All the information shall be in English and if it is in some other language, then its translated version shall be provided.

At Maven Profcon Services LLP, we specialize in regulatory consultancy for medical device manufacturers, catering to various needs such as Quality Management Systems (QMS), ISO13485 certification, USFDA 510k submissions, MDSAP, EU MDR compliance, and Country Registrations in more than 150+ countries. Our comprehensive services ensure a streamlined approach to regulatory compliance, offering you everything you need in one place for successful medical device registration in Australia.

For Medical Devices Registration in Australia, contact us at enquiry@mavenprofserv.com or call +91-7490017774 / +91 7940026222. We’re here to assist you with registering your medical device in Australia.