Australian TGA Medical Device Regulations

We have assembled the following documents as a service to the medical device community. All were published by the Australian Therapeutic Goods Administration (TGA) and are in PDF format. Help us keep this list up to date. If you find a newer version of a document or one that should be included, please email us.

• Advertising Medical Devices Guidelines
• Alternative Therapies Guidelines
• Animal Material Assessment Guidelines
• Application Audits for Medical Devices
• Australian Regulatory Guidelines for Medical Devices (ARGMD)
• Boundary Products Guidelines
• Classification of Medical Devices
• Clinical Evidence Requirements
• Conformity Assessment Certificate Conditions
• Conformity Assessment Procedures (Guidance Document 3)
• Essential Principles Checklist
• IVD Pricing Schedule
• Labeling Requirements for Medical Devices
• Request to Transfer Sponsorship of ARTG Entry - Accepting Company
• Request to Transfer Sponsorship of ARTG Entry - Relinquishing Company
• Request to Transfer Sponsorship of ARTG Inclusions for Medical Devices - Accepting Company
• Responsibilities of Device Manufacturers
• Standards for Overseas Manufacturers
• Tamper Evident Packaging Codes
• TGA Fees - July 1 2009 to June 30 2010