Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 16, 2026
Approximately 5 minutes
Importing and Supplying Medical Devices in Australia – TGA Requirements
Importing and Supplying Medical Devices in Australia – TGA Requirements
Legal Requirements for Import and Supply
- All medical devices supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempt.
- Importation requires compliance with customs regulations and TGA requirements.
- Supply includes sale, distribution, or use within Australia.
Role of the Australian Sponsor
- Overseas manufacturers must appoint an Australian sponsor (entity or individual in Australia).
- Sponsor responsibilities include:
- ARTG application and maintenance.
- Regulatory communications with TGA.
- Adverse event reporting and vigilance.
- Recall coordination if needed.
- Sponsor must be listed in the ARTG entry.
Importation Process
- Customs clearance: Declare goods to Australian Border Force (ABF).
- Provide evidence of ARTG inclusion (ARTG number) when requested.
- Devices not in ARTG may be seized unless exempt or under special access.
- Pay any applicable import duties/taxes.
ARTG Inclusion Pathways
- Conformity assessment: Complete appropriate procedure based on classification (I–III).
- Application: Submit via TGA portal with evidence of conformity, technical documentation, and Declaration of Conformity.
- Fees: Pay assessment and inclusion fees.
- Processing: TGA reviews; time varies by class and complexity.
Key Compliance Obligations
- Labelling: Include sponsor details, ARTG number, instructions for use in English.
- Advertising: Comply with Therapeutic Goods Advertising Code.
- Post-market: Report incidents, monitor performance, maintain records.
- Custom-made devices: Specific rules apply for patient-specific devices.
Exemptions and Special Cases
- Exempt low-risk devices (e.g., certain Class I non-sterile/non-measuring).
- Special Access Scheme (SAS) or Authorised Prescriber for unapproved devices.
- Clinical trial supply under CTN/CTA schemes.
- Personal importation: Limited quantities for personal use.
Detailed requirements for sponsors, importers, ARTG pathways, customs procedures, labelling standards, advertising rules, exemptions, and special access provisions are outlined in the TGA guidance on importing and supplying medical devices. Source: Importing and supplying medical devices - TGA
This framework ensures only safe and compliant medical devices enter the Australian market while facilitating legitimate import and supply.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Applying for Export Certificates for Medical Devices – TGA Process
The Therapeutic Goods Administration (TGA) issues export certificates for medical devices to support overseas regulatory requirements, confirming that devices are lawfully supplied in Australia (or meet equivalent standards if not supplied locally), with applications submitted online and processed according to device classification and certificate type.
Approximately 5 minutes
Exporting Medicines from Australia – TGA Certification Requirements
The Therapeutic Goods Administration (TGA) issues export certificates for medicines to facilitate international trade by confirming that products meet Australian regulatory standards or are lawfully supplied in Australia, with applications processed online for registered, listed, or exempt medicines depending on supply status and destination requirements.
Approximately 5 minutes
Importing and Supplying Medical Devices in Australia – TGA Requirements
To import and supply medical devices in Australia, importers and sponsors must ensure the device is included in the ARTG (or exempt), appoint an Australian sponsor if overseas, comply with customs requirements, and meet labelling, advertising, and post-market obligations to ensure safety and performance.
Approximately 5 minutes
Application for Certificate of Free Sale or Export Certificate – Medical Devices (TGA)
The Therapeutic Goods Administration (TGA) provides an online form for sponsors to apply for a Certificate of Free Sale or Export Certificate for medical devices, confirming ARTG inclusion and compliance status to support export to countries requiring such documentation.
Approximately 5 minutes
Personal Importation Scheme for Unapproved Therapeutic Goods – TGA Rules
Australia's Personal Importation Scheme allows individuals to import limited quantities of unapproved prescription medicines or certain medical devices for personal use under strict conditions, including a maximum 3-month supply, valid prescription requirement for prescription medicines, and no advertising or commercial intent.