MDSAP Audit Approach and Key Updates

“This document outlines the regulatory framework for the Medical Device Single Audit Program (MDSAP) audit approach, providing key updates and guidance for conducting audits.

As of August 6, 2024, several modifications have been made to the MDSAP audit processes, including updates to tasks related to device marketing authorization, facility registration, purchasing, adverse event reporting, and quality management systems (QMS). References to MHLW MO169 have been harmonized with ISO 13485:2003 throughout, with updates to comply with U.S. accessibility requirements.

The MDSAP audit covers critical areas such as QMS planning, risk management, document control, and device distribution. The audit sequence is structured around key processes like management, measurement, analysis, improvement, design, and development. Sterility control for medical devices is emphasized during initial or recertification audits, while surveillance audits focus on validated process parameters and product release.

Annexes provide additional guidance on specific areas such as sterile medical devices, adverse event reporting, and Japan’s QMS ordinance revision. These updates ensure that the MDSAP audit process aligns with global regulatory standards, streamlining compliance for medical device manufacturers.”

Source:https://www.fda.gov/media/166672/download?attachment##~https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms

Region: United States of America