DITTA IMDRF Nov 2013 · – Brazilian Good Manufacturing Practices ... Quality management system...

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


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)

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

Présentateur

Commentaires de présentation

This effort hopes to limit redundant regulatory information exchange through maximized use of the platform Facilitates secure exchange and collaboration of global regulators This global approach opens possibilities and pathways to support the development of an international coalition of countries dedicated to pooling technology, resources and services to improve the safety and oversight of medical products on an international scale.

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


SESSION 1:REGULATOR

PERSPECTIVES

Q&A


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

mailto:[email protected]

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

Présentateur


Speakers notes TÜV SÜD’s history dates back to the mid-19th century, a time when heavy steam boiler explosions caused many fatalities and major damage to buildings. The idea of founding an association for the testing and inspection of steam boilers was born. TÜV SÜD AG, was established on 6 January 1866 as The Baden Steam Boiler Inspection Association with the objective to protect people, environment and property against the adverse effects of technology. The TÜV SÜD Group today evolved from mergers throughout Southern Germany in the 1990s. Today, the company continues to pursue a strategy of internationalization and growth.

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

Présentateur


Speakers notes We support customers to achieve market success with our range of services in the CERTIFICATION strategic business segment. These services go beyond certification but share the common objective of helping our customer achieve market success. Manufacturing & industrial machinery: We support components manufacturers, contractors, installation providers, equipment manufacturers and operators with testing, inspection, system certification and training services. Consumer products & retail: We support all stakeholders along the entire value chain and all types of services including electrical & electronics, food, health & beauty, hardlines, softlines and toys & children’s products with a complete suite of testing, auditing, inspection, product certification, knowledge services, system certification and training services. Healthcare & medical devices: TÜV SÜD is well equipped to support customers in delivering the highest quality of healthcare and medical devices services. We are the world’s leading Notified Body in medical device conformity assessment and have the most competent personnel qualified to evaluate a wide range of products including high risk medical devices. Our global network of experts comprises medical professionals from a wide spectrum of healthcare specialisations. We provide a complete suite of technical solutions to meet our customers needs. Telecommunications & IT: From the early stage of design, TÜV SÜD supports its clients to ensure that their electrical, electronic and radio communication devices are safe, reliable and compliant with all relevant legislation. When products are ready to be launched, we test and certify them against the requirements of all applicable standards, using our international network of experts to speed up access to global markets.

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


• 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


• 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


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


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


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


Program Evolves

Program settling in

14/03/2017


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


Program future outlook

14/03/2017


1. New jurisdictions engage2. Current jurisdictions expand use of MDSAP audit for other approvals


SESSION 2:ASSESSING ORGANIZATION

(AO) PERSPECTIVES

Q&A


BREAK:30 MINUTES

Refreshments served in foyer


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


MAJOR THEMES

• Most respondents did NOT participate in MDSAP pilot

• Those that DID participate found value in the program


MAJOR THEMES

• Most participants only signed up 1 facility/manufacturing site


MAJOR THEMES

…although they are planning to add more


MAJOR THEMES

Overall experience of participants: POSITIVE!


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


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!


GENERAL INFORMATION

• Most survey respondents sell into all MDSAP countries


GENERAL INFORMATION

• More of respondents’ business is covered by MDSAP than is not


GENERAL INFORMATION

• Most respondents used US FDA’s online resources


GENERAL INFORMATION

• Most respondents reported that the survey touched all aspects of concern with MDSAP


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


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



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.


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


Overall comment – Yes!

Positive and to be welcomed


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


Capacity within the Auditing Organisations (AO)


How many trained MDSAP Inspectors does each AO have ?


How many actual inspectors with the AOs with the MDSAP skill set?

CLASS

CLINICAL

LOG ACTIVE

MDD

STERI


The Global Expansion of the MDSAP Programme.


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.


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


How did Industry respond to the MDSAP request for action?

YOUR REGULATOR

WANTS YOU!


Participating manufacturers (June 2016)


Overall score for Industry (My opinion)

We Passed but with

much to doand to

learn!5/10


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.


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)

104

https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM535976.pdf




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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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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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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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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Thank you

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PERSPECTIVES

Q&A


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


CLOSING SESSION:PANEL DISCUSSION

Q&A

MDSAP:CURRENT STATUS AND

FUTURE PLANS

Thank you!

DITTA IMDRF Nov 2013 · – Brazilian Good Manufacturing Practices ... Quality management system...

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