Australia 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 marketing [at] emergogroup [dot] com (send us an email).

Major Regulations

• TGA Therapeutic Goods Amendment Regulations 2010
• TGA Therapeutic Goods (Medical Devices) Amendment Regulations 2010

General Guidance Documents

• Australian Regulatory Guidelines for Medical Devices (ARGMD)
• Boundary Products Guidelines

Specific Guidance Documents

• Alternative Therapies Guidelines
• Standards for Overseas Manufacturers
• Responsibilities of Device Manufacturers
• Tamper Evident Packaging Codes

Forms and Applications

• Essential Principles Checklist
• Form Transfer Sponsorship of ARTG Entry Accepting Company
• Form Transfer Sponsorship of ARTG Inclusions for Accepting Company
• Form Transfer Sponsorship of ARTG Entry Relinquishing Company

Additional Information

• IVD Pricing Schedule
• TGA Fees - 1 July 2011