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Manufacturer's Evidence

Overview​

Manufacturer's evidence is the conformity assessment documentation that a manufacturer must have accepted by the TGA before a sponsor can submit a valid ARTG inclusion application for most device classes above Class I. The evidence is submitted by the sponsor on behalf of the manufacturer. Once accepted, the manufacturer evidence is linked to the sponsor's ARTG application. A single set of accepted manufacturer evidence can support multiple ARTG applications from the same or different sponsors, subject to scope.

When Manufacturer Evidence Must Be Submitted First​

For Class IIa, IIb, III, and most IVD classes, manufacturer evidence must be submitted to and accepted by the TGA before the ARTG inclusion application can proceed. There are two steps in the process:

  1. Manufacturer evidence submission — the sponsor submits the manufacturer's conformity assessment documents to the TGA
  2. ARTG inclusion application — once the manufacturer evidence is accepted, the sponsor submits the application for ARTG inclusion

For Class I and Class 1 IVD devices, the manufacturer evidence is submitted with (not before) the ARTG inclusion application.

What Manufacturer Evidence Consists Of​

The specific documents required depend on the device class and the chosen evidence pathway. Typically the evidence package includes:

  • QMS certificate — ISO 13485 certificate (or equivalent), scoped to the relevant device type, issued by an accepted certification body
  • Product certificate — for Class IIb, Class III, and higher IVD classes: a CE certificate from an EU notified body, TGA Conformity Assessment Certificate, or equivalent from an accepted comparable overseas regulator, covering the specific device type
  • Declaration of Conformity — signed by the manufacturer for all device classes

The exact combination of documents required is specified in Table 2 of the comparable overseas regulator guidance and in the ARTG inclusion requirements:

👉 Required evidence by device class — TGA guidance

Keeping Manufacturer Evidence Current​

Manufacturer evidence must remain valid and current for as long as the device is included in the ARTG. The sponsor is responsible for monitoring the status of the manufacturer's certificates and notifying the TGA if certificates are suspended, revoked, or allowed to lapse. If manufacturer evidence expires or is withdrawn:

  • The device may not be supplied until valid replacement evidence is accepted
  • The sponsor must notify the TGA promptly
  • A new ARTG application may be required in some cases

This is a common compliance issue — sponsors should have systems in place to track expiry dates of all conformity assessment certificates for devices they sponsor.

Written Agreement with the Manufacturer​

Sponsors must have a written agreement with the manufacturer that ensures the manufacturer will provide regulatory information — including updated evidence — when required. The agreement must enable the sponsor to obtain the manufacturer's evidence and technical documentation within 20 working days of a TGA request.

Official Sources​