Overview & Procedures
An overview of conformity assessment for Australian medical devices — what it is, which procedures apply to which device classes, and how the process works.
TGA Certification
How to apply for a TGA-issued Conformity Assessment Certificate — when it is required, what the process involves, and how long it takes.
Comparable Overseas Regulators
Which overseas regulatory approvals and certifications are accepted by the TGA as manufacturer evidence for Australian ARTG applications, and how to use them.
Manufacturer's Evidence
What manufacturer's evidence is, when it must be submitted and accepted before an ARTG application can proceed, and how to manage it over time.
Declaration of Conformity
What a Declaration of Conformity is, what it must contain, who signs it, and how it fits into the Australian conformity assessment framework.