Extension of Remote and Hybrid Auditing Pilot - MDSAP AU P0036

MDSAP Transmittal Number: AO 2024-07

Transmittal Date: 2024/08/01

Title: Extension of the MDSAP AU P0036.002 Remote and Hybrid Auditing Pilot Program until March 31st, 2025

Purpose and Summary of Change: The MDSAP Auditing Organizations (AOs) have adopted the use of fully remote and hybrid (partially remote) audits into their audit scheduling with over 30% of all MDSAP audits now performed at least partially offsite. The 18-month Pilot as defined in procedure P0036 was scheduled to finish in September 2024.

To provide certainty and allow forward planning for AOs and participating medical device manufacturers, the Pilot will be extended until March 31st, 2025. The requirements, as defined in MDSAP AU P0036 will apply in full for the extension period.

Post-pilot evaluation: The Regulatory Authority Council (RAC) is reviewing the Pilot outcomes including evaluation data and feedback from stakeholders in the coming months to determine the conditions for the ongoing use of remote and hybrid audits. The RAC will finalize and publish requirements for the post-pilot use of remote/hybrid audits in late 2024. Considering that AOs plan audits up to 6 months in advance and to allow a transition period, the extension of the P0036 period has been set to March 31st, 2025.

AOs are encouraged to contact their assigned Assessment Program Manager (APM) to discuss any questions or concerns related to this transmittal.

Approver: Andrew Bathgate, TGA

Effective Date: 2024/08/01

Distribution: MDSAP AOs, RAs

Action Requested: Apply MDSAP AU P0036 Pilot extension measure until March 31st, 2025.

Location of Document: BOX (restricted access)

Issued by: MDSAP APMs