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![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.”](https://image.slidesharecdn.com/339a871b-ec2f-4dee-868a-60debcbe0bf5-160116132517/75/MDSAP-4-2048.jpg)
Uploaded byDr. Peter Drechsler
MDSAP
The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
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MDSAP
- 1. MEDICAL DEVICE SINGLE AUDITPROGRAM Medical Device Regulatory Conference 2.-3.12.2015
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- 3. IMDRF International MedicalDevice Regulatory Forum
- 4. MISSION IMDRF/MC/N1FINAL:2014 “The mission ofthe 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 February2011 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 Medicaldevice 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 groupitems: 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
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- 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 MDSAPaudit 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
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- 15. MDSAP PILOT Pilot startedin 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 Asof 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 Asof June 2015 World Health Organization (WHO) Prequalification of In Vitro Diagnostics Program European Union
- 18. AUTHORIZED AO SeeMid-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. SITESData: 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 AssociateDirector, 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…”
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- 22. BENEFITS FOR MANUFACTURERS Noadditional 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 - INTEGRATEDOR 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 routineaudits 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 willoperate 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 NationalHealth 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 intendingto 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 willaccept 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.
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- 30. RESOURCES Medical DeviceSingle 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 – ENKOSIKAKHULU NGIYABONGA – I NKOMU – NDI A LIVHUHA THANK YOU – NDIYABULELA – KE ITUMETSE KE A LEBOGA – BAIE DANKIE – DANKE SCHÖN
- 33. CONTACT DETAILS Dr. PeterDrechsler ▪ 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.