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Conformity Assessment & Overseas Evidence
Manufacturer Evidence & Conformity Assessment Strategy
Manufacturer Evidence is a core gate in the Australian pathway. For most device and IVD applications, the Sponsor must hold an accepted Manufacturer Evidence identifier before the ARTG application can proceed. The evidence must be current, applicable to the manufacturer and appropriate for the risk class and product scope.
When This Support Is Needed
Preparing a first Australian ARTG application
Using EU, UK, US, Canadian or other overseas regulatory evidence to support Australia
Changing certification body, conformity assessment certificate, manufacturing site or legal manufacturer
Transitioning from older EU certificates to MDR / IVDR certificates
Extending a product family or adding models under existing evidence
Responding to a TGA question about the adequacy or scope of manufacturer evidence
What We Challenge Before Submission
Certificate scope narrower than the products proposed for ARTG inclusion
Different manufacturer names, sites or legal entities across certificates and declarations
Evidence that covers a related product but not the same design / intended purpose
Expired, superseded or transition-dependent evidence
Using overseas evidence without confirming it is acceptable for the Australian class and application type
Our Support Includes
Review of TGA Conformity Assessment Certificates where applicable
Review of acceptable comparable overseas regulator / assessment body evidence (EU MDR/IVDR, US FDA, Health Canada, Japan PMDA)
Manufacturer Evidence application and variation strategy in TGA Business Services
QMS certificate and product-assessment evidence review
Declaration of Conformity drafting and review
Certificate scope, device family and classification alignment
Manufacturer legal name, site address and corporate entity consistency
Assessment of evidence validity, conditions of certification and transition status
Identification of evidence gaps before ARTG inclusion application
Strategy for certificate lapse, replacement, re-certification or variation
Senior Regulatory Question:
Can the Sponsor demonstrate, document by document, that the conformity assessment evidence applies to the same manufacturer, same device scope and same intended purpose being represented in Australia?
Secure Your TGA Manufacturer Evidence Acceptance
Our team verifies comparable overseas certificates, drafts Declarations of Conformity, and submits Manufacturer Evidence filings to TGA.