Medical Device Single Audit Program (MDSAP)
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
International partners that are participating in the MDSAP include:
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers
From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated summarizing the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the Medical Device Single Audit Program. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the three (3) year pilot.
Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.
FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.
- MDSAP P0035.001 Affiliate Members Roles and Responsibilities (NEW! as of June 5, 2019)
- MDSAP F0035.001 Affiliate Members Application Form (NEW! as of June 5, 2019)
Medical Device Firms and Auditing Organizations participating in the Medical Device Single Audit Program are invited to provide feedback through targeted surveys:
- Following each AUDIT, for the Medical Device Firm
- Following each AUDIT, for the Lead Auditor
- Following each ASSESSMENT, for the Auditing Organization
See what the industry has to say about MDSAP audits:
"Auditors followed published MDSAP audit guidance very closely. We are now preparing to obtain MDSAP certificates for all ISO 13485/CMDCAS locations when MDSAP becomes fully operational in 2017."
"MDSAP allows a reduction in the number of audits conducted resulting in less business disruption. The MDSAP audit was well planned and the well-organized audit expectations allowed us to plan resources ahead of time. Additionally, qualified and competent auditing organizations conduct audits in a consistent manner. The transition from our previous audit cycle to the MDSAP audit program was easy due to the documents available on the MDSAP website. Definitely, more sites will be added to the MDSAP program in 2017 and 2018."
"MDSAP auditors are experienced and well-trained and apply a task-based audit approach. There is a reduction in the number of audits which brings less business disruption. GREAT web-based materials and guidelines are available to industry."
MDSAP Stakeholder Day Presentations - December 5, 2018
On December 5, 2018, FDA participated in the MDSAP Stakeholder Day with the Therapeutic Goods Administration of Australia, Brazil's National Health Surveillance Agency, Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency and 200 representatives trade organizations and device manufacturers participating in MDSAP.
- 18-113 - AO Recognition Status
- 18-114 - HC MDSAP Transition Update
- 18-115 - ANVISA Regulatory Update
- 18-115 - FDA Regulatory Update
- 18-115 - Japan Regulatory Update
- 18-115 - TGA Regulatory Update
- 18-116 - FDA Update ISO 13485
- 18-117- Workshop Grading NC
MDSAP Stakeholder Day Presentations - May 9, 2018
On May 9, 2018, FDA participated in the MDSAP Stakeholder Day with the Therapeutic Goods Administration of Australia, Brazil's National Health Surveillance Agency, Health Canada, and Japan's Pharmaceuticals and Medical Devices Agency and representatives from 60 device manufacturers marketing in Canada.
- 18-28 - Recent Changes to MDSAP
- 18-30 - TGA - Recent and Upcoming Regulatory Changes
- 18-30 - Regulatory Updates - Brazil
- 18-30 - Regulatory Updates (PMDA)
- 18-31- Status of Transition in Canada
- 18-32 - How HC uses MDSAP
- 18-32 - How the RAs use MDSAP - Brazil
- 18-32 - How the Regulatory Authorities use MDSAP (FDA)
- 18-32 - How the Regulatory Authorities use MDSAP (PMDA)
- 18-32 - How the TGA uses MDSAP
- 18-33 - Workshop I - feedback
- 18-34 - Workshop II - feedback
Resources For You
- MDSAP Regulatory Authority Contact Information - February 14, 2018
- MDSAP Invitation - September 8, 2016
- Announcement of New MDSAP Modules
- CDRH Learn (Postmarket Activities Section/ Inspections - Global Harmonization)
- Regulatory Authority MDSAP Membership Announcement (New)
- MDSAP Final Pilot Report July 2017
- FDA EIR MDSAP Audit Report Equivalence, September 29, 2016
- New Candidate AO Participation in the Transitional Phase of the Medical Device Single Audit, November 29, 2016