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 If you would like to suggest a document for inclusion or we have included an outdated version, please let us know.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 for advertising medical devices in Australia.
Alternative Therapies
Using medical devices in non-conventional therapies.
Animal Material, Devices Using
Minimizing risks associated with Transmissible Spongiform Encephalopathies (TSE).
Application Audits, Medical Devices
Requirements before an application can be filed, product audits, contents, etc.
Boundary Products
Talks about distinctions between medical devices and medicines. Provides examples.
Clinical Evidence Requirements
Role of clinical evidence, data generation, requirements of a clinical evaluation.
Conformity Assessment Certificate Conditions
Discusses entry and inspection powers, review requirements, fees and more.
Conformity Assessment Procedures
What is a CAP, examinations for all device classes, plus post-market monitoring systems.
Declaration of Comformity Overview
Covers purpose of the DOC, responsibility for conformity assessment and procedures.
Classification of Medical Devices
Discusses different classes of devices and rules for invasive and non-invasive devices.
Essential Principles for Medical Devices
Discusses medical device safety, intended purpose, minimization of risk and much more.
Essential Principles Checklist
Detailed checklist the directly correlates with the Essential Principles listed above.
Labeling Requirements, Medical Devices
General requirements for device labels, including sterile and non-sterile products.
Overseas Manufacturers, Standards For
How overseas manufacturers must demonstrate their goods meet acceptable standards.
Postmarket Activities
Discusses postmarket surveillance, compliance, adverse events, vigilance and more.
Regulatory System Overview
Overview of the new medical devices regulatory system.
Sponsor Responsibilities
Role of the Sponsor/Manufacturer related to documentation, design, certification, etc.
Tamper Evident Packaging Codes
Requirements for wrappers, seals, packs, tubes, etc.. Covers validation and labeling.
TGA Fees
Complete schedule of fees as of 1 July 2007.
