The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. Products must be included in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor before supply. For medical devices, approvals from comparable overseas regulators – such as CE certification under the EU MDR – are often used as evidence.
TGA at a Glance
| Authority | Therapeutic Goods Administration (TGA) |
|---|---|
| Countries | Australia |
| Mark | AUST R / AUST L number |
| Requirement | Mandatory |
| Typical timeline | Varies – ask us |
| Validity | Ongoing, subject to annual charges |
| Local representative | Yes – Australian sponsor |
Products We Commonly Support
- Medicines & APIs
- Medical devices
- In-vitro diagnostics
- Surgical consumables
- Complementary medicines
How Global Approbation Handles TGA
- Step 1. Appoint an Australian sponsor who will hold the ARTG entry.
- Step 2. Classify the product (prescription / OTC / listed medicine, or device risk class).
- Step 3. Prepare the dossier or technical file, including manufacturer evidence (GMP clearance for medicines; conformity assessment for devices).
- Step 4. The sponsor submits the application to the TGA and responds to evaluation.
- Step 5. ARTG inclusion is granted; maintain annual charges, adverse-event reporting and variations.
Documents Required
- GMP certificate / clearance evidence for the manufacturing site
- Product dossier or device technical file
- Overseas approvals (e.g. EU MDR certificate, CoPP)
- Labels and instructions for use
- Sponsor agreement
TGA: Frequently Asked Questions
Is TGA mandatory in Australia?
Yes. Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor before supply; medical devices often use CE / EU MDR or other comparable overseas approvals as evidence.
Which products need TGA?
Typical products include Medicines & APIs, Medical devices, In-vitro diagnostics, Surgical consumables and Complementary medicines. Coverage follows the regulator's current list and HS codes, so we confirm it for your exact product.
Does a foreign manufacturer need a local representative for TGA?
Yes – Australian sponsor. Global Approbation coordinates with your importer or arranges a representative where needed.
How long does TGA take and how long is it valid?
Typical timeline: Varies – ask us. Validity: Ongoing, subject to annual charges. Share your product details for a realistic plan and cost.
Can an Indian company be the TGA sponsor?
No. The sponsor must be an Australian resident or company; we can connect you with sponsor services or work with your Australian distributor.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory or certification body.