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Medical Device Single Audit Program (MDSAP)

6 September 2019

The Medical Device Single Audit Program (MDSAP) has been designed to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the Quality Management System (QMS) and regulatory requirements of medical device manufacturers. These requirements are based on ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes, and the specific requirements from the medical device regulations of the participating regulatory authorities.

MDSAP allows for recognised Auditing Organizations to conduct a single programme of regulatory audits of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Therapeutic Goods Administration's (TGA) Role in MDSAP

The TGA has been a participating member of the MDSAP consortium since it was initiated as an International Medical Device Regulators Forum (IMDRF) work item in 2012.

The TGA currently uses MDSAP audit reports and certificates as part of the evidence that is assessed for compliance with medical device conformity assessment procedures and market authorisation requirements, unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports. Further details are provided in the 'Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)' guidance.

Manufacturers who have been audited under MDSAP may, under some circumstances, avoid routine TGA inspections, however our regulatory model still allows for the TGA to audit manufacturing premises regardless of the availability of MDSAP evidence.

MDSAP certificates are a kind of overseas regulator conformity assessment document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the Australian conformity assessment procedures, have been applied to a medical device by the manufacturer of the device. For MDSAP certificates and audit reports to be considered by the TGA, the Australian regulatory requirements must have been covered in the audit(s), and certificates* must show that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.

* Further information on MDASP Certificates requirements are detailed in MDSAP AU P0026.002 Certificate Document Requirements

MDSAP feedback and questions

Please send any feedback or questions related to TGAs involvement or use of MDSAP to: MDSAP@tga.gov.au

Additional information on MDSAP, including policies, procedures, forms and FAQs, is available on the FDA website.

Medical Device Firms and Auditing Organizations participating in MDSAP are also invited to provide feedback through targeted surveys accessible from the above FDA website.