1. MEDICAL DEVICE SINGLE
AUDIT PROGRAM
Medical Device Regulatory
Conference 2.-3.12.2015

2. DR. PETER DRECHSLER

3. IMDRF International Medical Device
Regulatory Forum

4. MISSION
IMDRF/MC/N1FINAL:2014
“The mission of the IMDRF [International Medical Device
Regulators Forum] is to strategically accelerate international
medical device regulatory convergence to promote an efficient
and effective regulatory model for medical devices that is
responsive to emerging challenges in the sector while
protecting and maximizing public health and safety.”

5. IMDRF born February 2011 as a forum to discuss future directions in medical
device regulatory harmonization.
Voluntary group of medical device regulators from around the world who
have come together to build on the strong foundational work of the Global
Harmonization Task Force on Medical Devices (GHTF)
Accelerate international medical device regulatory harmonization and
convergence.

6. 1992 - 2012
Medical device regulatory authorities & industry
Steering committee and 5 Study Groups covering subjects:
 Device Classifications; Labeling
 Post Market Surveillance, Adverse Event Reporting, Reports Exchange, GMDN
 Risk Management, Process Validation
 Auditor Training, Regulatory Auditing Guidelines
 Clinical Evaluations, Clinical Evidence

7. IMDRF Management Committee (MC) regulators:
 Australia, Brazil, Canada, China, the European Union, Japan, Russia, and the USA
Observers:
 APEC LSIF (Asia Pacific Economic Cooperation Life Science Innovation Forum)
 WHO - World Health Organization
Affiliate Organizations:
 Pan American Health Organization
 Asian Harmonization Working Party
Working Groups:
 Standards; MDSAP; Submissions; UDI; NCAR; Software

8. IMDRF Working group items:
National Competent Authorities Report Exchange Program
Roadmap for Implementation of Unique Device Identification system
Medical Device Single Audit Program
List of Recognized Standards
Regulated Product Submission
Software as a Medical Device

9. THE PROGRAM

10. Recognize Auditing Organizations (AO)
Single Audit by AO would:
 benefit patient health and patient access
 leverage regulatory resources
 minimize medical device manufacturing disruptions due to multiple regulatory
audits
 provide global benefit both on short term goals and longer term goals by IMDRF
regulators

11. STATEMENT OF COOPERATION (NOV 2012)
Australia
 Therapeutics Goods Administration (TGA)
Brazil
 Agência Nacional de Vigilância Sanitária
(ANVISA)
Canada
 Health Canada/Santé Canada
United States of America
 Food and Drug Administration (FDA)

12. COOPERATION
IMDRF
 Initial Recognition, Surveillance, and Re-Recognition Criteria for MDSAP
Recognized Auditing Organizations
 Standardized Recognized AO Auditor Competency and Competency Maintenance
Requirements
 Standardized Regulatory Authority Assessor Competency and Competency
Maintenance Requirements
Standardized Audit and Assessment Models
 Auditing of a Manufacturer by an MDSAP Recognized AO
 Assessment of MDSAP Recognized AO’s by participating Regulatory Authorities

13. COOPERATION
Audit duration calculations
MDSAP audit model for consistency
MDSAP report
Standardized Rating System for Manufacturer Audit Findings
Standardized Rating System for Recognized Auditing Organization
Assessment Findings
Extremely stringent impartiality requirements

14. THE PILOT

15. MDSAP PILOT
Pilot started in January 2014 (for 3 years, to Dec 2016)
CB’s from participating member states can apply to AO’s
 CMDCAS recognized registrars
Office audit and witnessed audit required
 Conducted by regulators
September 2014 AO’s started conducting audits
Operational program slated for 2017

16. PARTICIPATING RAS As of June 2015
USA: U.S. Food and Drug Administration (FDA)
Canada: Health Canada/Santé Canada
Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
Australia: Therapeutics Goods Administration (TGA)
Japan: Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and
Medical Devices Agency (PMDA)

17. OFFICIAL OBSERVERS As of June 2015
World Health Organization (WHO) Prequalification of In Vitro Diagnostics Program
European Union

18. AUTHORIZED AO See Mid-Pilot-Report
.
BSI Group America Inc. http://www.bsigroup.com/en-US/
TÜV SÜD America Inc. http://www.tuv-sud-america.com/
SAI Global Cert. Services PTY Ltd. http://www.qmi.com
LNE G-MED http://www.gmed.fr
TÜV USA Inc. http://www.tuv-nord.com/us
Intertek Testing Services NA Inc. http://www.intertek.com

19. PARTICIPATING MFG. SITES Data: Mid Pilot Report
Forecast: Myself
1
10
100
1000
10000
Aug-14
Oct-14
Dec-14
Feb-15
Apr-15
Jun-15
Aug-15
Oct-15
Dec-15
Feb-16
Apr-16
Jun-16
Aug-16
Oct-16
Dec-16
Cumulative total

20. KIMBERLY TRAUTMAN, FDA
Associate Director, International Affairs
Office of the Center Director
Center for Devices and Radiological Health
Personal communication, 2015-10-22:
“…MDSAP is definitely going full implementation in January 2017,
so manufacturers should take advantage of the ‘learning
phase’ while they can…”

21. BENEFITS

22. BENEFITS FOR MANUFACTURERS
No additional requirements for manufacturers
Single audit optimizes time and resources
Routine audits are scheduled/planned with manufacturer
Expected to improve predictability
Expected to add additional Regulatory Authorities
Some RA’s will use Pilot audit outcomes as alternatives to own inspections to process
applications for market authorization

23. PROCESS - INTEGRATED OR
STAND ALONE, MORE COMPLEX?
MDSAP can be integrated into existing audit cycle
CE requirements are not built into MDSAP audit tasks and not considered part of MDSAP
audit time, must added
Multi-site manufacturers do not get a certificate unless all relevant sites are audited under
MDSAP
No such thing as an MDSAP pre-assessment in traditional sense (all reports go to all RAs, all
NC’s count)

24. MDSAP Pilot routine audits are announced, scheduled by the Auditing Organization with the
manufacturer, with a pre-established duration.
The FDA will review MDSAP Pilot audit reports with a level of scrutiny commensurate to the
significance of audit findings, taking into account the review and follow-up performed by the
Auditing Organization.
Firms have one month to provide their full response to critical nonconformities (grade 4 and
5) to the Auditing Organization (as opposed to 15 working days following a FDA inspection).
Certification documents issued by the Auditing Organization state compliance with
applicable US regulations, which may provide a marketing advantage.
FDA will utilize other forms of Advisory Notice, where necessary instead of FDA Warning
Letters for MDSAP Audits during the Pilot. Warning Letters will only be considered when the
MDSAP audit conclusion reveals an imminent/unreasonable risk to public health.

25. Health Canada will operate the current Canadian Medical Devices Conformity
Assessment System (CMDCAS) and MDSAP in parallel during the three year pilot.
Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for
the purpose of obtaining a new (or maintaining an existing) Class II, III, or IV medical
device license, pursuant to section 32 of the Canadian Medical Devices Regulations.
Upon the successful conclusion of the pilot, Health Canada intends to implement
MDSAP as the mechanism to achieve regulatory compliance for quality
management system requirements in Canada.

26. The Brazilian National Health Surveillance Agency – ANVISA will utilize the
outcomes of the program, including the reports, to constitute an important input on
ANVISA’s pre-market and post-market assessment procedures, providing, when
applicable, key information that are expected to support regulatory technical
evaluation on these issues.
Due to recent regulatory changes (RDC 15:2014), ANVISA may use MDSAP Pilot
audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP
Certificate to manufacturers intending to put medical devices of class III or IV on the
Brazilian market. Undergoing an MDSAP Pilot audit may accelerate ANVISA ́s GMP
certification process, which is a pre-requisite to the marketing authorization.
ANVISA can also use MDSAP Pilot audits to renew ANVISA’s GMP Certificate bi-
annually, as an alternative to an ANVISA comprehensive inspection.

27. For manufacturers intending to put medical devices of class II, III or IV on the
Japanese market, an MDSAP Pilot audit report might be utilized for a desk review
instead of a premarket inspection performed by PMDA or registered certification
bodies in Japan. An MDSAP Pilot audit report might also be utilized in this manner
for periodical post market inspections.
Undergoing an MDSAP Pilot audit may accelerate the Marketing Authorization with
fewer burdens as well as reduce some burden for a post market phase.

28. The TGA will accept MDSAP certificates as evidence of compliance with
ISO13485:2003 where the Standard has been used to demonstrate partial
compliance with the requirements of an Australian Conformity Assessment
Procedure. It is expected that Australian Sponsors may be required to submit to the
TGA, additional technical documentation to demonstrate compliance with the
requirements of the Essential Principles of Safety and Performance and the
manufacturer’s chosen Conformity Assessment Procedure.
The TGA will take into account MDSAP audit reports when deciding whether to issue
or maintain a TGA Conformity Assessment Certificate. Under some circumstances a
manufacturer may avoid routine TGA inspections.

29. FURTHER READING

30. RESOURCES Medical Device Single Audit
Program
http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/
http://www.imdrf.org/workitems/wi-mdsap.asp

31. INFORMATION
Pilot Program Announcement (brief description) - link
Program Announcement (including benefits) - link
MDSAP FAQs - link
Eligible Auditing Organizations – link
MDSAP Audit Procedures & Forms - link

32. NGEYABONGA – ENKOSI KAKHULU
NGIYABONGA – I NKOMU – NDI A LIVHUHA
THANK YOU – NDIYABULELA – KE ITUMETSE
KE A LEBOGA – BAIE DANKIE – DANKE SCHÖN

33. CONTACT DETAILS
Dr. Peter Drechsler ▪ Member of the Executive Board
qtec group ▪ Humboldtstraße 30/32 ▪ 70771 Leinfelden-Echterdingen ▪ Germany
Mobile: +49 173/2462720 ▪ Phone: +49 711/469273-40
Email: peter.drechsler@qtec-group.com
Internet: www.qtec-group.com ▪ DoEasy: www.DoEasy.de
Helping you to concentrate on your core competencies: the product and the market.