News

Announcing revision 11 of the MDSAP Audit Approach

Acceptance and use of MDSAP certificates is growing worldwide, with the pathway of reliance making it easier for manufacturers to comply with the QMS regulatory requirements of multiple regulatory authorities.

A summary of the outcomes from the 2026 MDSAP Forum.

Extension of the pilot program allowing Medical Device Organizations (MDOs) to participate in MDSAP

The first annual MDSAP RAC Report highlights key 2025 achievements and reinforces the RAC's commitment to advancing global regulatory collaboration.

This document sets out the roles and responsibilities of the MDSAP Industry Group and provides clarification on the group’s purpose, roles, responsibilities, operations, tenure and obligations in accordance with agreed terms with the MDSAP Regulatory Authority Council.

The 2026 MDSAP Forum, hosted by Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, will be held in Kyoto from Monday 15 June 2026 to Friday 19 June 2026.

The MDSAP Regulatory Authority Council is pleased to announce it has reviewed and accepted two new AO applications from Kiwa Ltd and mdc medical device certification GmbH.

A summary of outcomes from the 2025 MDSAP Forum.

The latest news on the reopening date for AO applications announced

The latest news on the reopening of AO applications for recognition and the introduction of new criteria for screening and prioritizing submissions.

Recent updates to MDSAP procedures, including Complaints and/or Customer Feedback

New online forms are now available for MDSAP Membership.

Advice on the release of the updated P0036 Remote / Hybrid Audit Procedure

Link to the notification on USFDA site of MDSAP moving into an operational status from a pilot program from March 2016.

In June 2015, Japan joined the Medical Device Single Audit Program (MDSAP) to promote global regulatory harmonization.

Link to the announcement of the Medical Device Single Audit Program International Coalition Pilot Program.

Link to MDSAP: Statement of Cooperation - signed by Heads of Regulatory Authority