News | Medical Device Single Audit Program (MDSAP)

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News

New MDSAP Auditing Organization Accepted Applicants

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.

24 April 2026

News

2026 MDSAP Forum

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.

27 February 2026

News

2025 MDSAP Forum Outcome Statement

A summary of outcomes from the 2025 MDSAP Forum.

18 December 2025

News

Announcement of reopening of AO applications – 1 July 2025

The latest news on the reopening date for AO applications announced

6 June 2025

News

Reopening of new AO applications and new eligibility and prioritization criteria

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

22 May 2025

News

New online MDSAP Membership Forms released

New online forms are now available for MDSAP Membership.

21 May 2025

News

Recent updates to MDSAP procedures

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

21 May 2025

News

Release of P0036.003 Remote / Hybrid Audit Procedure

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

28 March 2025

News

Federal Register Notice - Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase

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

17 December 2015

News

Japan joins the Medical Device Single Audit Program (MDSAP) June 23rd, 2015

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

23 June 2015

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Federal Register Notice - IMDRF MDSAP International Coalition Pilot Program, November 15, 2013

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

15 November 2013

News

MDSAP: 2013 Statement of Cooperation - signed by Heads of Regulatory Authority

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

27 November 2012