MDSAP Documents
Questions and Answers
Available Documents
- MDSAP Policies, Procedures, Templates and Forms
- MDSAP Audit Procedures and Forms
- MDSAP Assessment Procedures and Forms
- MDSAP Training Material
- MDSAP QMS Procedures and Forms
- IMDRF/MDSAP WG and GHTF Documents
- MDSAP International Regulations [English]
(Australia, Brazil, Canada, Japan, and USA) - MDSAP Databases Identifier in Preparation for Audits and Assessment
- ANVISA Website Guidelines
Notices and Announcements
Recent Announcements
- Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase
- MDSAP Mid-Pilot Report, August 2015
- Japan joins the Medical Device Single Audit Program (MDSAP) June 23rd, 2015
- MDSAP Announcement to Medical Device Manufacturers, January 2015
- MDSAP Pilot Announcement, January 2014
Past Announcements
Useful Links
- MDSAP Regulatory Authority Contact Information 14 February 2018
- International Medical Device Regulators Forum