Australian TGA Medical Device Regulations

We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are the latest versions, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please let us know. All documents were published by the Australian Therapeutic Goods Administration (TGA) and are in PDF format unless otherwise noted.

• Advertising Medical Devices Guidelines
• Alternative Therapies Guidelines
• Animal Material Assessment Guidelines
• Application Audits for Medical Devices
• Boundary Products Guidelines
• Classification of Medical Devices
• Clinical Evidence Requirements
• Conformity Assessment Certificate Conditions
• Essential Principles Checklist
• Labeling Requirements for Medical Devices
• Responsibilities of Device Manufacturers
• Standards for Overseas Manufacturers
• Tamper Evident Packaging Codes
• TGA Fees