News | Medical Device Single Audit Program (MDSAP)

News

The latest news on the reopening date for AO applications announced

6 June 2025

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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

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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

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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

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

27 November 2012