News | Medical Device Single Audit Program (MDSAP)

News

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 forms are now available for MDSAP Membership.

21 May 2025

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

21 May 2025

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

28 March 2025

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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

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

23 June 2015

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

15 November 2013

News

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

27 November 2012