Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
May 16, 2025
Approximately 5 minutes
Australia Medical Device License Maintenance: Annual Charges and ARTG Variations
Australia Medical Device License Maintenance: Annual Charges and ARTG Variations
For manufacturers to maintain their product's legal market access in Australia, the device's inclusion on the Australian Register of Therapeutic Goods (ARTG) must be actively maintained. License maintenance is overseen by the Therapeutic Goods Administration (TGA) and involves two key obligations: annual fees and mandatory reporting of modifications via variation applications. Failure to comply can lead to the revocation of the ARTG listing.
Mandatory Annual Charges
Manufacturers are required to pay an annual fee to the TGA to maintain their ARTG inclusion. These annual charges are invoiced every August.
| Medical Device Classification | Annual Charge (AUD) |
|---|---|
| AIMD & Class III | $1,200 |
| Class IIb & Class IIa | $940 |
| Class I (sterile or measuring function) | $640 |
| Class I (other) | $90 |
Modifications and Amendments (ARTG Variation)
Any changes to the product, the manufacturer's quality system, or supporting conformity assessment documentation must be reported to the TGA via a Variation to an ARTG inclusion entry. This application is necessary to update the device listing and its supporting Manufacturer's Evidence.
| Application Type | Application Fee (AUD) |
|---|---|
| Variation to an ARTG inclusion entry | $470 |
Examples of acceptable Manufacturer's Evidence Amendments that typically require a straightforward variation application, rather than a new registration, include:
- Change in Manufacturer's Details: Change in the manufacturer's name or address, provided this change does not result in a new legal manufacturer.
- Certificate Updates: The certificate number has changed, the certificate has expired and been re-issued, or the scope of the certificate has changed.
- Notified Body Change: The Notified Body or Conformity Assessment Body has changed.
- Document Updates: Changes to the evidence issue/expiry/re-issue dates, or a change in the conformity assessment procedure.
Role of the Australian Sponsor
The Australian Sponsor is responsible for managing these license maintenance obligations on behalf of the manufacturer. This includes:
- Ensuring annual charges are paid on time.
- Proactively monitoring the validity of the manufacturer's supporting conformity assessment certificates.
- Submitting Variation applications to the TGA whenever an acceptable change or update to the manufacturer's evidence occurs.
- Managing the process for a change of Australian Sponsor, which requires submission of a transfer form by the existing sponsor and then submission of updated manufacturer's evidence by the new sponsor.
Related Articles
Approximately 5 minutes
Australian Medical Device Registration: The Role of the Sponsor and TGA Inclusion
Medical device registration in Australia with the TGA requires an **Australian Sponsor** to facilitate market access. Registration involves demonstrating compliance with the **Essential Principles** through conformity assessment evidence (e.g., EU Notified Body certificates, FDA approvals). Products are listed on the **ARTG**, with higher-risk devices (Class III/AIMD) subject to mandatory **Level 2 audits**.
Approximately 5 minutes
Australian Medical Device Classification: TGA Risk-Based System
The TGA classifies medical devices based on risk, invasiveness, and intended use into Class I, IIa, IIb, III, and AIMD. This classification determines the required **Conformity Assessment** scrutiny, **Quality Management System (QMS)** requirements, and the complexity of achieving inclusion in the **Australian Register of Therapeutic Goods (ARTG)**.
Approximately 5 minutes
Australia Medical Device Labeling: TGA Compliance and Sponsor Requirements
Australian medical device labeling must adhere to the **TGA's Therapeutic Goods (Medical Devices) Regulations 2002**. The **Australian Sponsor's** name and address must appear on the outer packaging. Required information includes the device's intended use, manufacturer details, mandatory warnings, and full traceability data (batch/lot/serial number, and expiration date if applicable) to ensure safety and compliance with the Essential Principles.
Approximately 5 minutes
Australia Post-Market Surveillance: Sponsor's Role in TGA Vigilance
Post-Market Surveillance (PMS) in Australia is mandatory, with the **Australian Sponsor** being responsible for reporting all **Australian adverse incidents** and **overseas regulatory actions** to the TGA. For high-risk devices (AIMD, Class III, implantable Class IIb), the Sponsor must submit **three consecutive annual reports** detailing product complaints. The TGA uses these reports to initiate potential recalls, hazard alerts, or product modifications.