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.
November 16, 2025
Approximately 5 minutes
Australia Medical Device Labeling: TGA Compliance and Sponsor Requirements
Australia Medical Device Labeling: TGA Compliance and Sponsor Requirements
Medical device labeling in Australia is strictly regulated by the Therapeutic Goods Administration (TGA) and must comply with the Therapeutic Goods (Medical Devices) Regulations 2002. Proper labeling is essential for demonstrating adherence to the Essential Principles of safety and performance, which is mandatory for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Mandatory Sponsor and Manufacturer Information
A key requirement for market access is the clear identification of the responsible parties:
- Australian Sponsor Details: The name and address of the Australian Sponsor (the local authorized representative) must appear on the outer packaging label. This information can be added before or after customs clearance and is exempt from current Good Manufacturing Practice (GMP) requirements.
- Manufacturer Details: The name, trading name, and address of the manufacturer must be included.
Essential Label Content
Labels (including those on the device, outer packaging, and Instructions for Use) must contain sufficient information for the user to identify the product and use it safely. This includes:
- Intended Use: A clear description of the intended use, including the type of user and the kind of patient for whom the device is intended (if not obvious).
- Safety and Warnings: Mandatory warnings, restrictions, or precautions required for the safe and proper use of the device.
- Handling and Storage: Any necessary handling, storage, or operating instructions.
- Traceability: A batch code, lot number, or serial number for identification.
- Dates: A clear statement of the expiration date (month and year) if applicable, and the date of manufacture if not provided elsewhere.
- Usage Statement: If applicable, a statement indicating the device is for single use only.
Specific Labeling Requirements
- Sterile Devices: Must include the word “STERILE” and clearly state the sterilization method used.
- Custom-Made Devices: A statement must indicate that the device is intended for use only by the specific health professional or individual for whom it was custom-made.
- Devices Under Clinical Investigation: For medical devices undergoing pre-market clinical investigation or performance evaluation (including IVD devices), the label must clearly state their intended use for these purposes.
- Export Only: If the device is exclusively for export, the label must clearly state “for export only”.
Adherence to these precise labeling requirements ensures traceability, safety, and regulatory compliance for all medical devices imported into and supplied within the Australian market.
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 License Maintenance: Annual Charges and ARTG Variations
Maintaining medical device market access in Australia requires payment of mandatory **Annual Charges** to the TGA every August and submitting a **Variation to an ARTG inclusion entry** for any modifications. The Australian Sponsor is responsible for managing these obligations, which include updating **Manufacturer's Evidence** (e.g., renewed certificates, address changes) to prevent license revocation or suspension.
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.