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Seminar hosted by DITTA in conjunction with IMDRF
Monday, March 13 2017Vancouver, BC, Canada
MDSAP:CURRENT STATUS AND
FUTURE PLANS
A few words about our friend Klaus Stitz:
MDSAP: CURRENT STATUS AND FUTURE PLANS
OPENING REMARKS
Patrick Hope –Executive Director, MITA
DITTA Chair
Kimby Barton –Interim Director of the Medical Devices Bureau, Health Canada
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 1:REGULATOR
PERSPECTIVESMarc-Henri Winter –
Staff Fellow, MDSAP - Center for Devices and Radiological HealthU.S. Food and Drug Administration
Fabio Quintino Pereira –Manager - Office of GMP Inspection
Brazilian Health Regulatory Agency - ANVISA
Medical Device Single Audit ProgramOverview of the Program and its Mechanics
Marc-Henri Winter, Staff FellowFDA
6
Participants and ObserversParticipants• Therapeutics Goods
Administration (TGA) • Agência Nacional de Vigilância
Sanitária (ANVISA) • Health Canada
• MHLW* and PMDA**
• Food and Drug Administration (FDA)
ObserversWorld Health Organization (WHO) European Union
* Ministry of Health, Labor and Welfare ** Pharmaceuticals and Medical Device Agency
7
Operational Organization
Regulatory Authority Council (RAC)• MDSAP governing body:
– two senior managers from each participating jurisdiction.
– representation from observing jurisdictions.
Subject Matter Experts (SME) • Permanent or ad-hoc
working groups to:– Develop policies and
documents.
– Develop tools.
– Implement the program.
8
RA
AO Mfr
Assess and recognize
Share audit
reports
Concept
RA: Regulatory Authority; AO: Auditing Organization; Mfr: Manufacturer
Make regulatory
decisions
Audit and certify
9
Audit Criteria
• ISO 13485 (2003 2016)• Regulatory requirements
on Quality Systems– Brazilian Good
Manufacturing Practices (ANVISA RDC 16).
– Japanese requirements (MHLW MO 169).
– FDA’s Quality System Regulation (21 CFR Part 820).
• Specific national requirements on:– Registration of
manufacturer sites. – Licensing of medical
device. – Reporting adverse event
and advisory notices.– Device tracking.
10
Audit Method
• MDSAP Audit Model ─
11
Audit Method
• Recently updated to– Align with ISO 13485:2016.– Add clarifications on the audit of technical
documentation.– Add clarification on the audit of sterile products.
• Training modules:– For auditors: Articulate-online (including quiz).– For all: on the FDA CDRH Learn webpage.
(http://www.fda.gov/Training/CDRHLearn/default.htm)
12
Audit Nonconformity (NC) Grading• GHTF/SG3/N19:2012
Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.
QMS Impact• Direct: 3• Indirect: 1
Repeat NC• Yes: 1• No: 0
Lack of Document• Yes: 1• No: 0
Released Device• Yes: 1• No: 0
NC Grade = sum of 4 parameters, capped at 5
13
AO Journey To Recognition
Assessment Activity Status
Application reviewed favorably Application Received
Stage 1 + Stage 2 (+ Critical Locations) + Response to any nonconformity deemed acceptable
Authorized to conduct MDSAP audits (the first 3 to be witnessed)
3 Witnessed Audits + Response to any nonconformity deemed acceptable
Recognized
Recognition Decision
14
Auditing Organizations
Application Received
Authorized to ConductMDSAP Audits
Recognized
15
Manufacturer Participation
• Required to maintain Canadian Device Licencesafter 2018-12-31
• Voluntary and encouraged to -– Register devices in Australia – especially combination
products.
– Obtain ANVISA GMP certificate – devices class III and IV.
– Substitute to PMDA audits.
– Substitute routine FDA inspections – any devices.
16
International Value of MDSAP
• Europe will determine whether to become a participating member of the MDSAP coalition and if/ how they can use the outcomes of the program.
• WHO Prequalification of in vitro diagnostics use MDSAP audits to abbreviate or waive WHO inspections.
• Others – advocacy towards the use of MDSAP certificates by non-participating Regulatory Authorities.
MDSAP consortium: Current status, Timelines and Plans
Fábio P. QuintinoMDSAP RAC – Chair
Office of GMP Inspection for Medical Devices, Sanitizers and Cosmetics ANVISA-Brazil
CONTENT
HISTORY
STATUS
PERSPECTIVES
HISTORY From GHTF, IMDRF launched at planning
meeting in Ottawa in October 2011 where
ToR was drafted
Singapore meeting (March 2012) marked
official inauguration of IMDRF
One of the 5 inaugural work items
included - Medical Device Single Audit
IMDRF MDSAP WG PURPOSE
Develop standard set of requirements for
auditing organizations performing regulatory
audits of medical device manufacturers’
quality management systems
Represented a critical step in establishing any
Medical Device Single Audit Project
IMDRF MDSAP WG OUTCOMEDocuments for the Regulatory Authority assessments of AOs are based on:
IMDRF/MDSAP WG /N5 FINAL:2013 – “Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations”
IMDRF/MDSAP WG /N6 FINAL:2013 – “Regulatory Authority Assessor Competence and Training Requirements”
IMDRF/MDSAP WG/N8 FINAL:2015 – “Regulatory Authority Assessment Method Guidance”
IMDRF/MDSAP WG/N11 FINAL:2014 – “MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
Recognition, monitoring and re-recognition of Auditing Organizations documents:
IMDRF/MDSAP WG/N3FINAL:2013 – “Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition”
IMDRF/MDSAP WG/N4FINAL:2013 – “Competence and Training Requirements for Auditing Organizations”
IMDRF/MDSAP WG/N24 – “MDSAP Audit Report Guidance”
IMDRF MDSAP WG OUTCOME
SoC
Timeline
11/2012: Signature of the Statement ofCooperation for the development of a single audit program (TGA; ANVISA; HC; US FDA) 03/2013: Accelerated plan to develop thebasic structure for the 3 year pilot programstarting on 01/01/201406/2015: Japan (MHLW/PMDA) announces their participation in the pilot
12/2016: End of the pilot – Transition tooperational phase
CURRENT STATUS
MDSAP RECOGNIZED AOs
BSI Group America Inc. Intertek Testing Services NA Inc. TŰV SŰD America Inc.
26
AOs AUTHORIZED TO PERFORM MDSAP AUDITS DEKRA Certification B.V. DQS Medzinprodukte GmBH LNE G-MED SAI Global Cert. Services PTY Ltd. SGS United Kingdom Ltd. TŰV Rheinland of North America Inc. TŰV USA Inc. UL Medical and Regulatory Services, UL LCC
AOs UNDER AUTHORIZATION PROCESS
Lloid’s Registry Quality Assurance Inc. - LRQA National Standards Authority of Ireland – NSAI NSA Health Sciences Certification, LLC
As in march 9th
AUDIT NUMBERS
• 164 MDSAP Audits Reports to date
• 46 audits noted no nonconformities
• 118 audits had at least 1 nonconformity
Plans and Perspectives
Perspectives• Pilot report to be issued
• An expected fast grow of the program in the “transitional phase” poses challenges
Resource allocation MDSAP business model
implementation Establishment of new RA
admittance policies
Regulatory Exchange Platform –secure (REPs)
• IT solution to facilitate the exchange of confidential/non-public information (NPI), as well as the collaboration of regulators in a secure IT environment – Starting with MDSAP module
• Partners: ANVISA – Brazil, Health Canada, MHLW/PMDA – Japan, TGA - Australia, US FDA and PAHO (Pan American Health Organization)
• Development phase started on March 2017 – 2 years are estimated for completion
Perspectives
• Increase of the use of program outcomes by each RA, maximizing value
• Learning curve, process improvements and program scale up may allow cost reduction
Perspectives
• Consolidation as a global, effective and resource wise tool for the regulatory oversight of Medical Device Manufacturer’s QMS implementation.
Thanks for your Attention
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 1:REGULATOR
PERSPECTIVES
Q&A
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 2:ASSESSING ORGANIZATION
(AO) PERSPECTIVESGary Minks –
Vice President, Quality & Regulatory Affairs TÜV SÜD America Inc.
Patricia Murphy –Global Head, MDSAP Program
BSI Healthcare
TÜV SÜD
DITTA SeminarMDSAP; An Auditing Organization’s Perspective
Gary MinksTÜV SÜD America IncOffice: +1-978-573-2521Mobile: +1-978-884-5019Email: [email protected]
2017-03-13
14/03/2017 Corporate Presentation Slide 39
Our heritage: 150 years of business success
TÜV SÜD Slide 40TÜV SÜD Corporate presentation
Establishment of a Mannheim-based steam boiler inspection association by 22 operators and owners of steam boilers, with the objective of protecting man, the environment and property against technology-related risks
1866
First vehicle periodic technical inspection (PTI)1906
1958 Development of a Bavaria-wide network of vehicle inspection centers in the late 1950s
1926 Introduction of the “TÜV mark / stamp” in Germany
1990s Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia
TÜV SÜD continues to pursue a strategy of internationalisation and growth
Today
2006 Expansion of services in ASEAN by acquiring Singapore-based PSB Group
2009 Launch of Turkey-wide vehicle inspection by TÜVTURK
16-01-01
Achieve market success
TÜV SÜD Slide 41TÜV SÜD Corporate presentation
Manufacturing & industrial machinery
Consumer products & retail
Healthcare & medical devices
Telecommunications & IT
Services for components manufacturers, contractors, installation providers, equipment & material manufacturers and operators include: • Component testing• Periodic inspection of
equipment• Failure analysis• System certification• Training
Services for manufacturers, retailers, buyers and suppliers of electrical & electronics, food, health & beauty, hardlines, softlines, toys & children’s products: • Testing• Auditing• Inspection• Product certification• Knowledge services• System certification• Training
Services for medical device manufacturers and healthcare providers include: • Clinical approvals• Market approvals and
certification• Testing• Evaluation• System certification• Training
Services for equipment manufacturers and operators of infrastructure equipment and radio frequency wireless equipment include: • Design reviews• Testing• Software escrow• Product certification• System certification• Training
16-01-01
MDSAP - Successes
TÜV SÜD America Slide 4217-03-14
• Auditor on-line training for MDSAP program requirements. We are quickly ramping up our global MDSAP auditor capaciity.
• Collaboration between Regulators and Auditing Organizations during the pilot program
• Manufacturers have avoided US FDA and Australian TGA inspections.
• Manufacturers have used MDSAP audit reports to obtain ANVISA GMP certificates.
• TUV SUD is conducting combined MDSAP / European MDD audits.
MDSAP - Challenges
TÜV SÜD America Slide 4317-03-14
• Auditor Mentoring is a challenge in these early audits (i.e., pairing experienced auditors with first time auditors)
• Coverage of all 94 core tasks and regulatory authority specific tasks while conducting a Process Audit.
• The Audit Model works but it takes some experience. The auditors that have done several MDSAP audits report that they do get more comfortable over time. – Realign task numbers to more logically align with sequence of
audits
MDSAP - Challenges
TÜV SÜD America Slide 4417-03-14
• Combining MDSAP with European MDD (Medical Device Directive) audits. – Adding MDD requirements into the Audit Model would help.
• Surveillance audit man-days for small organizations• Manufacturer’s concern with regulator information sharing• Some customers change their attitude with MDSAP compared
to previous audits.• Scoping of multiple site audits (i.e., which sites to include)• 15 day limit for manufacturers to respond to nonconformities• Obtaining the correct DUNS numbers from manufacturers
DITTAMDSAP - Current Status and Future Plans
14/03/2017
45
Auditing Organization PerspectiveSuccesses & Challenges
Copyright © 2017 BSI. All rights reserved
Program Distinctions
Criteria ISO 13485 MDSAP
Program Customer Manufacturer Regulator
Output of success Certificate Report & Certificate
Auditing Organizations Qualification Competent Body Regulators
Audit Duration Employee count Fixed Timing
Nonconformance grading Major/Minor 1, 2, 3, 4, 5
Pilot Phase
2014 thru 2016
14/03/2017
Copyright © 2017 BSI. All rights reserved 47
Program Launches
Program Launch – Program Challenges
14/03/2017
Copyright © 2017 BSI. All rights reserved 48
1. Jurisdictional requirements• Interaction with ISO 13485• Complexity of differences• Inclusion of CE
2. Locations• How they interact• Where they are located
3. Adoption by manufacturers
4. Length of audit• Sufficient resources• Organization of audit plan
5. Reporting• Active voice• All jurisdictions• Specific timelines• NCR grading
Pilot Phase - 2014 thru 2016
14/03/2017
Copyright © 2017 BSI. All rights reserved 49
Audit Model Challenges
Auditors ManufacturersTask-based Confused by deliveryNot ISO 13485 Plus Single audit Deep Dive into processes
Consistent flow
Regulatory Audit Product - focusedRisk key part of audit Risk focus support
Pilot Program Successes
14/03/2017
Copyright © 2017 BSI. All rights reserved 50
1. Auditing organizations jumped into the program and encouraged manufacturers to engage
2. Manufacturers recognized cost benefit3. AO’s embraced regulatory audit model4. Five jurisdictions engaged 5. All stakeholders adapting to be successful
Operational Phase
2017
14/03/2017
Copyright © 2017 BSI. All rights reserved 51
Program Evolves
Program settling in
14/03/2017
Copyright © 2017 BSI. All rights reserved 52
Changes evolved through the Pilot and into Operational Phase
1. Audit task timeline changes2. Campus location defined3. Additional auditing organizations progressing through qualifications4. Manufacturers engagement growing dramatically in 2017, despite low numbers
in Pilot phase
Operational Phase
beyond 2017
14/03/2017
Copyright © 2017 BSI. All rights reserved 53
Program future outlook
14/03/2017
Copyright © 2017 BSI. All rights reserved 54
1. New jurisdictions engage2. Current jurisdictions expand use of MDSAP audit for other approvals
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 2:ASSESSING ORGANIZATION
(AO) PERSPECTIVES
Q&A
MDSAP: CURRENT STATUS AND FUTURE PLANS
BREAK:30 MINUTES
Refreshments served in foyer
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 3:REGULATED INDUSTRY
PERSPECTIVESMDSAP Industry Participation Survey: Findings
Presented at MDSAP: Current Status and Future PlansSeminar hosted by DITTA in conjunction with IMDRF
Monday, March 13 2017
Patrick HopeMITA Executive Director; DITTA Chair
MDSAP INDUSTRY PARTICIPATION SURVEY:
FINDINGS
MDSAP INDUSTRY PARTICIPATION SURVEY
INTRODUCTION
Objective:Improve industry participation in MDSAP
Goal: Widespread adoption and use of MDSAP
Survey methodology:Conducted online January 15-February 24
53 participants
MDSAP INDUSTRY PARTICIPATION SURVEY
MAJOR THEMES
• Most respondents did NOT participate in MDSAP pilot
• Those that DID participate found value in the program
MDSAP INDUSTRY PARTICIPATION SURVEY
MAJOR THEMES
• Most participants only signed up 1 facility/manufacturing site
MDSAP INDUSTRY PARTICIPATION SURVEY
MAJOR THEMES
…although they are planning to add more
MDSAP INDUSTRY PARTICIPATION SURVEY
MAJOR THEMES
Overall experience of participants: POSITIVE!
MDSAP INDUSTRY PARTICIPATION SURVEY
NON-PARTICIPANTS, EXPLAINED
• 55% did not attempt, deterred by cost or lack of interest
• 10.5% attempted, but deterred by issues with cost or AO
MDSAP INDUSTRY PARTICIPATION SURVEY
NON-PARTICIPANTS, EXPLAINED
• 34% report their decision not to participate was based on other, often complex factors
• However: none so complex that they can’t be fixed!
MDSAP INDUSTRY PARTICIPATION SURVEY
GENERAL INFORMATION
• Most survey respondents sell into all MDSAP countries
MDSAP INDUSTRY PARTICIPATION SURVEY
GENERAL INFORMATION
• More of respondents’ business is covered by MDSAP than is not
MDSAP INDUSTRY PARTICIPATION SURVEY
GENERAL INFORMATION
• Most respondents used US FDA’s online resources
MDSAP INDUSTRY PARTICIPATION SURVEY
GENERAL INFORMATION
• Most respondents reported that the survey touched all aspects of concern with MDSAP
MDSAP INDUSTRY PARTICIPATION SURVEY
TAKEAWAYS & NEXT STEPS
• Survey respondents that participated in MDSAP liked it
• Those that did not participate were open or planning to participate in MDSAP in the future
MDSAP INDUSTRY PARTICIPATION SURVEY
TAKEAWAYS & NEXT STEPS
MDSAP success depends on:• Regulators wide use MDSAP as total replacement
for current QMS audits• Auditors have sufficient capacity to carry out all
MDSAP audits by deadline• Industry has sufficient time for all facilities to
undergo MDSAP audit
THANK YOU!
www.globalditta.org
MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 3:REGULATED INDUSTRY
PERSPECTIVESPhilip Steinborn – Medtronic
Emmett Deveraux – Cook Medical
Naoki Morooka – Shimadzu Medical Systems
Vijay Madikonda – Johnson & Johnson Medical Devices
MEDTRONIC …
AND MDSAP
Phil SteinbornVP, Quality/RA Americas
75
MDSAP IS HERE TO STAYMEDTRONIC IS COMMITTED TO PROGRAM
Achievements: Where are we with MDSAP?
Challenges: What are the obstacles or risks as we see it?
Suggestions: Our recommendations for industry and the program.
1. 2. 3.
76
WHERE DO WE STAND WITH MDSAP?ACHIEVEMENTS
10+ FACILITIES ALREADY INSPECTED IN MDSAPPARTICIPATED IN PILOT PROGRAMNO OTHER INSPECTIONS AT MDSAP SITES TO DATEMDSAP CERTIFICATE ACCEPTED
SEVERAL WITNESSED AUDITS. TO PERMIT AOs TO ATTAIN QUALIFICATIONWORKING WITH MULTIPLE AOsSCHEDULING FOR OTHER FACILITIESPRIORITIZING CMDCAS SITES
77
WHAT ARE THE OBSTACLES OR RISKS?CHALLENGES
COMPLEXITY OF AUDIT Significant preparation required. Audit to 5 different sets of regulations– challenging. Annual inspection– more frequent than usual for
many of the participating regulators New process … Experiencing some delays in
getting audit reports– can adversely impact registrations. Price tag for MDSAP audit significantly higher Are we saving with annual audits or does it balance
out?RESPONSE FROM REGULATORS Regulators receiving annual MDSAP audit
reports– how will they react? FDA will treat Grade 4 and 5 findings as OAI (Official
Action Indicated) .. May result in Warning Letter. Regulators may send AOs back in to follow up on
gaps in audit report (... or go themselves) . Opportunity for regulators to uphold very
particular requirements of their regulations.
• 4 AOs FULLY ACCREDITED
• 4 AOs IN WITNESSED AUDITS STAGE OF ACCREDITATION
• 5 AOs IN PRELIMINARY ASSESSMENT PROCESS
• DO AOs HAVE SUFFICIENT NUMBER OF MDSAP TRAINED AUDITORS?
• CAN WE GET TIMELY MDSAP AUDITS SCHEDULED?
CAPACITY OF PROGRAMCAN AOs MEET DEMAND?
78
OUR RECOMMENDATIONS FOR INDUSTRY AND PROGRAMSUGGESTIONS
FOR INDUSTRY FOR PROGRAM
Prepare for the audits. Use the MDSAP Companion documents.
Sticking points tend to be unique req’ts of countries. Identify these!
Engage AOs early. Get on their schedules and allow them to plan accordingly.
Take AO findings seriously. Regulators are getting your reports.
Don’t forget about OEMs that are CMDCAS. They also need MDSAP.
Significant concerns about capacity. Availability of AOs and qualified auditors a real issue.
Consider low risk manufacturers go to single surveillance over the 3 year cycle … to help alleviate backlog.
Current MDSAP model is not expandable. Audit is too complex with multiple sets of regulations.
Need to align on a single audit standard (to meet local regulations)… such as ISO 13485:2016.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
G O V E R N M E N T A F FA I R S
Global Regulatory Developments An Industry Perspective on the Medical Device Single Audit
Programme (MDSAP)
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Cook Medical’s history with MDSAP
• Volunteered for the program in December 2014.
• First Inspection was in April, 2015 (Witnessed AO Inspection)
• Second MDSAP Inspection February 2016 (Non Witnessed)
• We believe we were one of the first in Europe and the first Irish Site.
• Two manufacturing sites in Europe but Ireland was chosen as the test site.
• Great Team at the Cook Ireland site and the success is down to them.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION.
What this presentation is notgoing to be – A detailed technical discussion on the MDSAP Instead it will be a very top level personalopinion of the MDSAP principle and achievements to-date
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Overall comment – Yes!
Positive and to be welcomed
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Like anything new – there are some concerns.
• Capacity concerns within the Auditing Organisations.
• The expansion of the MDSAP Programme
• Full benefits to Industry, incl. SMEs, yet to be realised
• Full EU Participation
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Capacity within the Auditing Organisations (AO)
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
How many trained MDSAP Inspectors does each AO have ?
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
How many actual inspectors with the AOs with the MDSAP skill set?
CLASS
CLINICAL
LOG ACTIVE
MDD
STERI
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
The Global Expansion of the MDSAP Programme.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Benefits for Industry – yet to be fully realized
• It’s a considerable expense so the benefits have to meet all expectations, incl SME’s
• The principle is solid and its concept is one that industry and the patient will benefit from.
• The true benefit will come once the programme has developed and become truly global in nature.
• For now my advice is to stay involved but work with the Regulators to ensure that the benefits are realized for all stakeholders.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Full EU Participation?
• EU have decided not to join the full programme.
• Resource Issues
• Industry would encourage that the EU come on board as a full member
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
How did Industry respond to the MDSAP request for action?
YOUR REGULATOR
WANTS YOU!
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Participating manufacturers (June 2016)
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Overall score for Industry (My opinion)
We Passed but with
much to doand to
learn!5/10
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Why do I say that?
• IMDRF as you know replaced the GHTF model 5 years ago
• Industry comments on IMDRF have been consistent – We need to be at the table and be more than just observers.
• IMDRF gave us this opportunity for MDSAP but unfortunately we were slow in joining the pilot.
• Lets learn from this and move on together.
COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
Well done and please let it grow and expand and reach its full potential!
CORP-D30444-EN
Session 3MDSAP Pilot – Experience and Barriers to Participation in Japan
Naoki MorookaSenior Manager, Quality Assurance DepartmentMedical Systems Division, Shimadzu Corporation13 March, 2017
Contents
Introduction Consideration for implementation Steps for implementation Suggestion
Additional Information of SpeakerNaoki Morooka*SC member of DITTA*Chairman of QMS committee in JIRA.*Chairman of QMS committee in JFMDA.
97
Introduction- MDSAP Pilot in Japan
Pilot stage in Japan 1st Phase until 31 December 2016 2nd Phase until 31 December 2018
For Approved ProductRequired documents by PMDA MDSAP report required for QMS inspection. Reduce the required documentation for Review by PMDA.
For Certified ProductRegistered Certification Body also required to accept them.
98
Introduction-MDSAP Pilot in Japan
Registered AOs Application Received 13 organizations Authorized to Conduct MDSAP Audits 11 organizations Recognition 3 organizationsAlmost AOs have local office in Japan.Ref.: List of AOshttps://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM429978.pdf
Implementation Japan into MDSAP pilot. Japanese QMS requirements were placed into Companion Document. And then, the auditors in AOs was trained according to Companion
Document. PMDA received a few application for QMS inspection based on MDSAP
report.Ref.: Companion Documentshttps://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377580.htm
99
Introduction-Company Profile and Certification Scope Company Profile
Shimadzu CorporationMedical Systems DivisionLocation: Kyoto, Japan
Product/Certification Scope Diagnostic X-ray Devices Angiographic X-ray Diagnostic Systems Nuclear Medicine Diagnostic Systems Medical Image Managements Systems Near infrared fluorescence Imaging System(NIRS) Tumor-Tracking Systems for Radiotherapy Systems
Certification/Auditing ISO13485:2003/ ISO9001 CMDCAS, MDD Annex II, Japan-PMD Act MO169 All certifications were issued by same Certification Body.
<Single Audit/ Multi-Certification/Report> US-FDA 21CFRpart 820, ANVISA, CFDA, etc.Audited by RA.
Angiography Systems General Radiography Systems
Fluoroscopy Systems
PET Scanner for Mammography Imaging
Tumor-Tracking Systems for Radiotherapy Systems
NIRS Systems
Mobile X-ray Systems
100
Consideration
Timing and Cycle for Certification Audit MDSAP Certification Audit
For implementation of MDSAP, “Certification Scope Extension” was not considered in Audit Model.
Full Audit required.
Timing for Certification AuditSynchronize with existing Certification Cycles.
in order to reduce the auditing cost.Transition period for Key Standards/Regulation
MDSAP pilot 31 December 2016.ISO 9001:2015 14 September 2018.CMDCAS 31 December 2018.ISO13485:2016 28 February 2019.
101
Consideration Certification Cycles in our company
Certification Audit
Surveillance Audit
Surveillance Audit Certification
Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
Certification Audit
Surveillance Audit
Surveillance Audit
Certification Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
Certification Audit
Surveillance Audit
Surveillance Audit
Certification Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
ISO13485:2003 Cert.3 years CycleISO13485:2016Transition Period2019.2.28
CMDCAS3years CycleMDSAPTransition Period2018.12.31
ISO9001:2008 Cert.3 years CycleISO9001:2015Transition Period2018.9.14
Certification Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
Surveillance Audit
Certification Audit
Surveillance Audit
Surveilla Audit
MDD or J-PMDAct5years Cycle
2016.05
2018.09.14
2018.12.31
2019.2.28
Certification Audit
Surveillance Audit
MDSAPISO13485:2016ISO9001:20152018.05
Our Current Target Schedule
Our AO was not
recognized yet.
102
Steps for implementation
Steps Decision for schedule for Certification Audit as
MDSAP Selection of AO Gap Analysis/Impact Assessments Modification/Adjustment for QMS Internal Audit Management Review Certification Audit by AO
103
Steps for implementation-Key elements
Gap Analysis/Impact Assessments Details Audit Model
MDSAP AU P0002.003 Audit Model (PDF - 882KB)(ISO 13485:2003)
MDSAP AU P0002.004 Audit Model (PDF - 770KB)(ISO 13485 :2016) New
Companion Document MDSAP AU G0002.1.003: Companion Document (PDF - 1.5MB)
(ISO 13485 :2003) MDSAP AU G0002.1.004: Companion Document (PDF - 1.2MB)
(ISO 13485 :2016) New Difference of Auditing Approach Top down approach Review for Subsystem (FDA-QSIT oriented)
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Steps for implementation- key elements Sample description in Companion DocumentChapter 1 - task 8. Verify that procedures have been defined, documented, and implemented for the control of documents and records of both internal and external origin required by the quality management system. Confirm the organization retains records and at least one obsolete copy of controlled documents for a period of time at least equivalent to the lifetime of the device, but not less than two years from the date of product release. Clause and Regulation: [ISO 13485:2016: 4.1.4, 4.2.1, 4.2.4, 4.2.5; TG(MD)R Sch3 P1 1.4(4); RDC ANVISA 16/2013: 3.1; MHLW MO169: 5, 6, 8, 9,; 21 CFR 820.40, 820.180] Additional country-specific requirements: Australia (TGA): Confirm that Quality Management System documentation and records in relation to a device described in TG(MD)R Sch3 P1 1.9 are retained by the manufacturer for at least 5 years. Brazil (ANVISA): Verify that change records include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective [RDC ANVISA 16/2013: 3.1.5]. ……………Japan (MHLW) Confirm that Quality Management System documentation and records in relation to a device are retained for the following………………….
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Steps for implementation -Key elements Consideration for Reporting
For Deviation, Grading system was applied according to GHTF/SG3/N19:2012
Ref:http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n19-2012-nonconformity-grading-121102.doc
Grading Matrix
Final Nonconformity Grade
Step 2Escalation Rules
Step 1Grading Matrix
Nonconformity
Grading Overview
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SuggestionFor Regulators Scope Extension Audit
Scope Extension Audit for ISO13485 Certification was not considered in Audit Model.
Implementation Guide for Manufacturer.Manufacturer might need “Implementation Guide for Manufacturer” for better understanding for MDSAP.
For Regulators and AOs Capacity of AOs in 2018/2019?
So many company will request certification audit in 2018 or 2019. Do AOs have capability for them?
For Industry Benefit
We are considering to reduce auditing by US-FDA and ANVISA.
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Medical Device Single Audit Program (MDSAP)
Ethicon Experience
Vijay Kumar MadikondaEthicon Compliance
March 13, 2017
Confidential – For J&J Use Only
Agenda
• Ethicon Inc. Achievements
• Audit Experience & Challenges
• Suggestions/Feedback on the MDSAP Program
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Confidential – For J&J Use Only
Achievements: MDSAP Pilot Update• Ethicon and Mentor Business units of J&J participated in the MDSAP Pilot
Program. Details of the sites piloted for the MDSAP are as follows:
• MDSAP Plans for 2017: • Added 6 more Ethicon sites to the MDSAP program and inspections
scheduled in 2017. • Multiple J&J Medical device sites are moving into MDSAP program.
SITE Most recent MDSAPaudit dates
Type of Audit Site Activities Product supply
Ethicon LLC, San Lorenzo May 19-22, 2015 & Mar 15-18, 2016
MDSAP SurveillanceMDSAP Surveillance
Manufacturer WW supply including US, Canada, Australia, Brazil & Japan
Ethicon SARL, Neuchatel Aug 25-27, 2015 &June 28-July 1, 2016
MDSAP CertificationMDSAP Surveillance
Manufacturer WW supply including US, Canada, Australia, Brazil & Japan
Ethicon Inc., Somerville Dec 1-2, 2015Jun 1-3, 2016
MDSAP SurveillanceMDSAP Surveillance
Design, Regulatory, PMS, Complaint handling
WW supply including US, Canada, Australia, Brazil & Japan
Ethicon Inc., Durango, Juarez
Jun 7-8, 2016 MDSAP Surveillance Manufacturer WW supply including US, Canada, Australia, Brazil & Japan
Mentor Irving July 14-18, 2015June 21-24, 2016
MDSAP CertificationMDSAP Surveillance
Design, RA, PMS, CQ, Mfg. WW supply including US, Canada, Australia, Brazil & Japan
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Confidential – For J&J Use Only
Audit Experience & Challenges
• Audit Process:• Transparent and Task-based • Audit Model follows Companion Document• Very thorough audits and evaluated compliance to all regulations
• Audit Duration:– Longer audit times – No significant difference between Recertification and Surveillance audit
time.
• Challenges:• Challenges in scheduling of the Audits due to limited trained auditors.• Review of some information not related to the site scope (design, complaint
handling, Regulatory, Quality systems) required Franchise participation in each site audits.
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Confidential – For J&J Use Only
Feedback on the MDSAP Program: Positive:• Well trained auditing organizations
conducting audits in a consistent way.
• Training materials and Guidance available of MDSAP website.
• Reduction in the number of Audits & Less business disruption.
• Harmonization of requirements.
Suggestions/Opportunities:• Train more auditors to support full MDSAP
implementation.
• Timely issuance of audit reports and MDSAP certificates.
• Expand the scope of MDSAP acceptability to include “For cause” inspections as AO’s can conduct Special audits to follow-up on Post market issues, significant findings from previous audits and based on request from participating regulatory authorities.
• Post audit timeline of D0+30 for providing evidence of implementation of remediation actions addressing Grade 4 or 5 observations is too short if robust actions are to be implemented.
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Confidential – For J&J Use Only
Thank you
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MDSAP: CURRENT STATUS AND FUTURE PLANS
SESSION 3:REGULATED INDUSTRY
PERSPECTIVES
Q&A
MDSAP: CURRENT STATUS AND FUTURE PLANS
CLOSING SESSION:PANEL DISCUSSION
Moderator: Brian Lewis, MEDEC
Marc-Henri Winter - USFDA
Jun Kitahara – PMDA Japan
Nancy Shadeed – Health Canada
Cheryl McCrae – TGA Australia
Fabio Quintino Pereira – ANVISA Brazil
Gary Minks – TÜV SÜD America Inc.
Patricia Murphy – BSI Healthcare
MDSAP: CURRENT STATUS AND FUTURE PLANS
CLOSING SESSION:PANEL DISCUSSION
Q&A
MDSAP:CURRENT STATUS AND
FUTURE PLANS
Thank you!