MDSAP · Medium · 14 min lesson
Australia - TGA, TG(MD)R Schedule 3, sponsor-manufacturer agreements and conformity assessment evidence
MDSAP Audit Approach Australian notes (chapters 2 and 4), Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3, TGA manufacturer evidence and MDSAP guidance, ISO 13485:2016 clauses 4.1.5, 7.2.1 and 8.2
What you will learn
- Explain the roles of the Australian sponsor and the manufacturer and the duties each keeps.
- Use an MDSAP certificate and audit reports as conformity assessment evidence for the TGA and know its limits.
- Write the points of a sponsor and manufacturer agreement that an MDSAP auditor can test.
Key takeaways
- The sponsor is an Australian entity that holds the ARTG listing; the manufacturer keeps the quality system, technical file and declaration of conformity.
- Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 sets conformity assessment procedures by class; manufacturer evidence shows they were applied.
- An MDSAP certificate works as evidence only if Australian requirements were in the audit scope; Class I devices follow other rules.
- The TGA may review MDSAP audit reports and can audit at any time, so findings and responses are read by the regulator.
- A controlled written agreement with the sponsor on the label should exist before supply and cover reporting, recalls, records, changes and termination.
Free practice question
Harbourline Medical, a company in Sydney, applies for ARTG inclusion of Kestrel's bone plates. Kestrel's quality manager says that Harbourline is now the manufacturer for MDSAP purposes.
What is the best reply?
Yes; once a sponsor applies, the sponsor takes over the manufacturer duties in Australia.
Not quite. Sponsor status does not transfer design, production or quality system duties under ISO 13485 clause 4.1.
No; Kestrel remains the manufacturer with the quality system and technical file, and Harbourline is the sponsor.
Correct. The MDSAP Audit Approach for Australia separates sponsor from manufacturer, and the manufacturer keeps ISO 13485 responsibility.
Yes; only the sponsor needs an MDSAP certificate under the programme.
Not quite. MDSAP certificates are issued to manufacturers whose quality system the auditing organization assessed.
No; Harbourline must be audited as a distributor in the MDSAP programme.
Not quite. The MDSAP audit examines the manufacturer, and sponsor duties are verified through the written agreement noted in chapter 2.
Key terms
- sponsor: The Australian entity that applies for ARTG inclusion and carries the continuing listing duties for the device.
- ARTG: The Australian Register of Therapeutic Goods, on which a device must be included before it can be supplied.
- manufacturer evidence: Conformity assessment documents for the manufacturer's quality system that the sponsor submits to the TGA to obtain an identifier.
- Schedule 3: The part of the Therapeutic Goods (Medical Devices) Regulations 2002 that sets conformity assessment procedures.
- declaration of conformity: The manufacturer's signed statement that the device meets the requirements, held for each listed device.
- TGA: The Australian regulator of therapeutic goods, which is a regulatory authority in MDSAP and not an auditing organization.
Official sources
- TGA, Medical Device Single Audit Program (MDSAP) frequently asked questions
- TGA, Manufacturer evidence for medical devices
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.