13/11/2020 Medical Device Single Audit Program (MDSAP) | FDA

Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) (http://www.imdrf.org/) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) 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:

MDSAP Members
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
U.S. Food and Drug Administration

MDSAP Official Observers:

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics
(IVDs) Programme
European Union (EU)

MDSAP Affiliate Members: (New)

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
Republic of Korea's Ministry of Food and Drug Safety

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.

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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.

Recent Updates
COVID-19 Remote Audits (/media/136441/download)(New: June 5, 2020)
ANVISA Resolutions (http://wcms-internet.fda.gov/medical-devices/medical-device-
single-audit-program-mdsap/anvisa-resolutions-medical-device-single-audit-program-
mdsap) (New: December 18, 2019)
MDSAP P0035.001 Affiliate Members Roles and Responsibilities
(/media/127697/download) (Published June 5, 2019)
MDSAP F0035.001 Affiliate Members Application Form
(/media/127700/download) (Published June 5, 2019)

Auditing Organizations
AO Availability To Conduct MDSAP Audits 10-08-2020 (/media/142182/download)
ANVISA Resolutions (/medical-devices/medical-device-single-audit-program-
mdsap/anvisa-resolutions)

Participant Survey
Medical Device Firms and Auditing Organizations participating in the Medical Device Single
Audit Program are invited to provide feedback at the survey link below:

Following each AUDIT, for the Medical Device Firm

(https://www.surveymonkey.com/r/mdsapmanuf3)  (http://www.fda.gov/about-
fda/website-policies/website-disclaimer)

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See what the industry has to say about MDSAP audits:

"With a Mission to improve the quality of life for patients, prevent progression of chronic diseases, and reduce
overall healthcare system costs, ResMed is committed to driving innovation and e ciencies across all aspects
of our business. The MDSAP program has allowed us to consolidate the global regulatory assessment process
across multiple international locations, reducing internal costs while increasing the overall predictability of
these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering
the safest, most effective and technologically advanced products possible. ResMed is proud to participate in a
program that is designed to increase e ciencies within our industry while having a positive impact on the cost
of global healthcare."

"Auditors followed published MDSAP audit guidance very closely. We are now preparing to obtain MDSAP
certi cates 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, quali ed 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. De nitely, 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 5-6, 2019

On December 5-6, 2019, 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 regulators from
Argentina's National Administration of Drugs, Foods and Medical Devices, Colombia's National
Institute for Food and Drug Surveillance, South Korea's Medical Device Safety Bureau, Taiwan
Food and Drug Administration and Venezuela's INHRR.

TGA Use of MDSAP (/media/140211/download)

ANVISA Update (/media/140212/download)

HC Update (/media/140213/download)

MHLW and PMDA Use of MDSAP (/media/140214/download)

FDA Use of MDSAP - Regulatory Updates (/media/140215/download)

MDSAP Stakeholder Day Presentations - December 5, 2018

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13/11/2020 Medical Device Single Audit Program (MDSAP) | FDA

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 (/media/123484/download)

18-114 - HC MDSAP Transition Update (/media/123482/download)

18-115 - ANVISA Regulatory Update (/media/123483/download)

18-115 - FDA Regulatory Update (/media/123485/download)

18-115 - Japan Regulatory Update (/media/123486/download)

18-115 - TGA Regulatory Update (/media/123487/download)

18-116 - FDA Update ISO 13485 (/media/123488/download)

18-117- Workshop Grading NC (/media/123489/download)

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 (/media/113270/download)

18-30 - TGA - Recent and Upcoming Regulatory Changes (/media/113283/download)

18-30 - Regulatory Updates - Brazil (/media/113286/download)

18-30 - Regulatory Updates (PMDA) (/media/113290/download)

18-31- Status of Transition in Canada (/media/113293/download)

18-32 - How HC uses MDSAP (/media/113299/download)

18-32 - How the RAs use MDSAP - Brazil (/media/113312/download)

18-32 - How the Regulatory Authorities use MDSAP (FDA) (/media/113318/download)

18-32 - How the Regulatory Authorities use MDSAP (PMDA) (/media/113324/download)

18-32 - How the TGA uses MDSAP (/media/113469/download)

18-33 - Workshop I - feedback (/media/113330/download)

18-34 - Workshop II - feedback (/media/113333/download)

Resources For You

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MDSAP Regulatory Authority Contact Information - July 15, 2019

(/media/92796/download)

MDSAP Invitation - September 8, 2016 (/media/99884/download)

Announcement of New MDSAP Modules (/media/100663/download)

CDRH Learn (Postmarket Activities Section/ Inspections - Global Harmonization)

(/cdrhlearn)

Regulatory Authority MDSAP Membership Announcement (New) (/medical-

devices/medical-device-single-audit-program-mdsap/regulatory-authority-mdsap-
membership-announcement)

MDSAP Final Pilot Report July 2017 (/media/106289/download)

FDA EIR MDSAP Audit Report Equivalence, September 29, 2016

(/media/100620/download)

New Candidate AO Participation in the Transitional Phase of the Medical Device Single
Audit, November 29, 2016 (/media/102062/download)

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