Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
We recently introduced new features to improve your experience using Guidance on our website.
Loading...
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
- (-) In Vitro Diagnostic medical devices (IVDs) (41)
- (-) Labelling and packaging (27)
- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (24)
- Australian Register of Therapeutic Goods (ARTG) (30)
- Biological medicines (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (30)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- Legislation (8)
- Listed medicines (25)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicine safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (49)
- Over the counter (OTC) medicines (36)
- Prescription medicines (48)
- Registered complementary medicines (16)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (2)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (32)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
Search
68 result(s) found, displaying 1 to 25
-
GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
GuidanceProvides Guidance on the regulatory requirements for labels and other medicine presentation.
-
GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
-
GuidanceTimeframes for supplying UDI compliant medical devices in Australia
-
GuidanceThis Guidance explains how overseas assessments can support our medical device certification and registration processes.
-
GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
-
GuidanceGuidance for sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
-
GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
-
GuidanceGuidance on the regulatory requirements for assessed listed medicines.
-
GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
-
GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
-
GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
-
GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
-
GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
-
GuidanceGuidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
-
GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device in the Australian Register of Therapeutic Goods.
-
GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
-
GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
-
GuidanceGuidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
-
GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
-
GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
-
GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
-
GuidanceGuidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.