Medical Devices Single Audit Program MDSAP - Overview and Update

Keith M Smith Senior Adviser and MDSAP Assessor Quality Audits and Assessments Section Medical Devices Branch Medical Devices and Product Quality Division ARCS Scientific Congress Canberra, August, 2016

Objectives • TGA’s International Programs

• IMDRF MDSAP Model • MDSAP Pilot • Audits • Assessments • Implementation • Participation • Questions

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TGA’s International Programs • Seeking to collaborate with other Regulators in innovative ways

– Share resources and the regulatory work – Leverage external resources and systems – Converge requirements and expectations – Build consistency and confidence in outcomes

• The MDSAP is a significant international program! … we envisage … – Benefits manufacturers through a reduced number of audits, reduced annual cost, an increase

in the predictability of outcomes, and opportunities for export markets. – Benefits Sponsors as an additional basis for market authorisation. (ARTG entry) – Benefits Regulators as it frees resources to target risk areas

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IMDRF MDSAP Model

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MDSAP model • Allows recognized Auditing Organisations to conduct audits of a medical device

manufacturer that will satisfy the relevant Quality Management System requirements of multiple participating Regulatory Authorities.

• Referred to as a “single” audit program

• Started development in 2012 by the International Medical Device Regulators Forum (IMDRF) – Successor of the Global Harmonisation Task Force – Australia, Brazil, Canada, China, Europe, Japan, Russia, and the United States of America

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CONCEPT

Regulatory Authorities

Assess and recognize Share audit

report and certificate

Make regulatory decisions – Market Authorisation

Auditing Organisations Audit and certify

Medical Device Manufacturers

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MDSAP Pilot

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MDSAP Pilot • International consortium of some of the countries who are members of the IMDRF

who are dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale in an Audit and Assessment Pilot Program – Memorandum of Understanding, Brazil, November 2012

• MDSAP Pilot – January 2014 – December 2016

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MDSAP Pilot - International Consortium

• MDSAP international consortium of countries: – Therapeutic Goods Administration (TGA) of Australia, – Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), – Health Canada, – Japanese MHLW and PMDA, and – U.S. Food and Drug Administration (US FDA)

• Observers – World Health Organisation (WHO) Diagnostic Prequalification Program – European Union May make a decision about full participation later in 2016

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MDSAP Pilot – Governance and Operations

• Regulatory Authority Council (RAC)

• International Subject Matter Expert (SME) Working Groups

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Regulatory Authority Council (RAC) • The MDSAP governing body is the RAC

– Two senior managers from each participating jurisdiction – Representation from observing jurisdictions (WHO and EU)

• Responsibilities: – Perform executive planning, strategic priorities, sets policy and make final decisions on behalf of

the MDSAP Consortium. – Final review and approval of MDSAP documentation; policy, procedures, work instructions, etc. – Auditing Organisation authorisation and recognition decisions

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Subject matter expert (SME) working groups

• MDSAP Audit and Assessment SME – Develops procedures, work flows, work instructions, templates, training, etc. for The auditing of medical device manufacturers by recognized Auditing Organisations The assessment of Auditing Organisations by Regulatory Authorities A Quality Management System for the operation of the MDSAP

• Regulatory Exchange Platform secure (REPs) SME – Developed IT requirements and specifications for REPsecure – Overseeing the Cooperative Agreements with the Host Organisation Pan American Health Organisation (PAHO)

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MDSAP Audits by Auditing Organisations

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MDSAP Audit Process: Model and Criteria • The design of each layer of the MDSAP seeks to define relevant objectives,

processes, competence management requirements and outputs.

• The audit process for medical device manufacturers provides for an efficient and thorough coverage of each QMS process requirement – Documented in an “Audit Model” and “Companion Guide” – Defines a prescribed audit “process” approach – The sequence of the audit of QMS processes ensures information determined early in the audit

informs the audit of processes later in the audit. – Annual audits

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MDSAP Audit Process: Model and Criteria • Each QMS process has objectives and a series of tasks to determine compliance

with ISO13485 and Regulatory requirements.

• Regulatory requirements include, for example: – Registration of manufacturing sites – Licensing of medical devices – Reporting of adverse event and advisory notices (recalls) – Tracking of specified devices – Review of technical documentation in the context of audit

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MDSAP audit process: Model and criteria

• An Auditing Organisation’s activities are directed by a number of documents, for example: – Audit Model and Companion Guide – Nonconformity Grading and RA Exchange Form and Guide – Audit Report Template and Policy / Guide – Audit Time Calculations – Post Audit Timeline – Certification document content – Notification of manufacturer participation, etc

• Full process is defined in “MDSAP Audit Procedures and Forms” – Web search “FDA MDSAP Pilot” for the complete listing

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MDSAP audit model

- Sequence to audit QMS processes for ISO 13485 and Regulatory Requirements

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Management

Measurement, Analysis and Improvement

Device Marketing Authorisation and

Facility Registration

Measurement, Analysis and Improvement

MD Adverse Events and Advisory Notice

Reporting

Design and Development

Device Marketing Authorisation and

Facility Registration

Production and Service Controls

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Nonconformity grading • GHTF N19 - Nonconformity

Grading System for Regulatory Purposes

• NCs are assigned a grade, 1 to 5 • Calculated in two steps

– Grading Matrix – Escalation Rules No Documented Process, +1 Release of nonconforming medical

device, +1

First Repeat

3 4

1 2 Occurrence

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Indi

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Cl 4

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6.3

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irect

Cl 6

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8.5

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Post audit timeline • 5 Working Day Notification

– Auditing Organisation informs MDSAP Regulatory Authorities of 1 or more Grade 5 Nonconformities, or >2 Grade 4 Nonconformities, or public health threat/fraud

• 15 Calendar Days – Medical Device manufacturer provides remediation plan

• 30 Calendar Days – Medical Device manufacturer provides evidence of implementation of remediation actions for

any grade 4 or 5 nonconformities • 45 or 90 Calendar Days

– Auditing Organisations submits full audit report package – 45 days in cases where a 5 day notification was required.

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MDSAP – Manufacturer Audit Program

t ud

iA Initial Audit Surveillance Audit Recertification Audit

Special Audit, Unannounced Audit, Regulatory Authority audit

Stage 1 Stage 1 – (as needed) Stage 1 – (as needed)

s Documentation Review Documentation Review Documentation Review

ieitivtcA t Review audit reports, Stage 2 Review of changes,

udi corrections/corrective

A On-Site Full Audit management process, actions, tasks not M,A&I, registration, covered in previous authorisation, etc. audits 19

MDSAP Assessments by Regulatory Authorities

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MDSAP Auditing Organisation Assessment Criteria

• An MDSAP Assessment is based on the model established by the IMDRF MDSAP documents that refer to the relevant ISO Standard, primarily … – ISO/IEC 17021:2011 – Reqs for bodies providing audit and certification of management systems – N3 – Requirements for Auditing Organisations – N5 – Regulatory Authority assessment method – N11 – Auditing Organisation Nonconformity Grading and Decision Process – … includes verification that AOs are auditing regulatory requirements

• Full process is defined in “MDSAP Assessment Procedures and Forms” – Application, Assessment, Decision Making etc. – Web search “FDA MDSAP Pilot” for the complete listing

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RA assessment method: Processes

Outsourcing

• Management (including Impartiality)

• Measurement, Analysis and Improvement

• Competency Management

• Audit and Certification Process

• Information Management

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A

sses

smen

t MDSAP – Auditing Organisation Assessment Program

Initial Assessment

Application Review

Stage 1 Assessment including Documentation Review

Stage 2 On-Site Assessment (Head Office)

3 Witnessed Audits

Surveillance Assessment Re-Recognition Assessment

On-Site Assessment of all Critical Locations

(as necessary)

Surveillance On-Site Assessment (Head Office)

1 Witnessed Audit

1 Witnessed Audit per Critical Location per Assessment

Cycle (as necessary)

Stage 1 Assessment including Documentation

Review for changes

Re-Recognition On-Site Assessment (Head Office)

1 Witnessed Audit

1 Witnessed Audit per Critical Location per Assessment

Cycle (as necessary)

Asse

ssm

ent A

ctiv

ities

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Summary: Assessment versus audit Assessment and Recognition • of Auditing Organisation

by Regulatory Authorities • of compliance to the IMDRF

Recognition Criteria – ISO/IEC 17021, IMDRF N3, N5, N11

etc, GHTF N19

• 4-year cycle • MDSAP Assessment Model

Audits and Certification • of Medical Device manufacturers

by Auditing Organisation • of compliance to ISO 13485, plus specific

quality system requirements from the participating RAs’ regulations

• 3-year cycle • MDSAP Audit Model

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MDSAP Implementation

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Timeline

IMDRF Model and Pilot

Development

CMDCAS Registrar

Assessment / Witness Audits

ISO13485:2003 to 2016,

CMDCAS to MDSAP

Global System??

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Auditing organisations and the MDSAP Pilot • Stages of Assessment

– Application Review – Stage 1 - Documentation Review – Stage 2 - Head Office and Critical Location on-site assessments – When any nonconformities have been closed the AO is “Authorised” to conduct MDSAP audits

under the Pilot arrangements – 1st MDSAP audit by the AO is witnessed then all assessment material is reviewed to confirm

continued Authorisation. – A minimum of 2 additional MDSAP audits are to be performed and witnessed to meet the

minimum recognition criteria

– Regulatory Authorities will announce the successful Auditing Organisations at the Pilot and grant them full MDSAP Auditing Organisation Recognition.

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Facts: Assessment activities • Application Review: 13 • Stage 1 Assessment: 10 • Stage 2 Assessment: 10 • Critical Locations: 5 • Witnessed Audit: 11 • Surveillance Assessment: 7 • Special Assessment: 1

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Auditing organisations and the MDSAP Pilot • During the Pilot, only the Auditing

Organisations recognized under the Canadian CMDCAS program were allowed to participate. – All 13 have applied and are progressing

through the stages of assessment – Others will be allowed to apply from 1

January 2017 – See “AO Availability” for an updated listing

on MDSAP website.

• BSI Group America • TUV SUD America Inc. • Intertek Testing Services • LNE G-MED • SAI Global Certification Services • TUV USA Inc. • LRQA • DQS Med • DEKRA Certification B.V. • TUV Rheinland N.A. Inc. • NSAI • SGS UK Ltd. • UL, LLC 29

MDSAP Participation

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Participating manufacturers (June 2016)

6 9 10 25

11 23 24

106 15

25

50 61

83

107 117

0

20

40

60

80

100

120

140

Sites Added

Cumulative Total

Q3, Q1, Q2, Q3, Q4, Q1, Q2, July, 2014 2015 2015 2015 2015 2016 2016 2016

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Profile of manufacturers currently participating

• Organisations selling into Canada and internationally • Manufacturing sites for finished medical devices • Relatively large organisations

– ~ 70 people and more

• Manufacturers of combination products selling into Australia • Organisations intending to sell in Brazil • Manufacturers of high risk medical devices • Organisations participating in the WHO Prequalification of IVDs Program

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Why should manufacturers participate? • Limit the number of medical device regulatory audits • Improvement in predictability of audit outcomes • Facilitate the application for marketing authorisation in countries where a quality

management system audit is a prerequisite • Anticipate the transition towards the mandatory application of MDSAP in Canada

• Be a part of the process during the pilot to help shape the policies and procedures for the operational program scheduled to begin in 2017

• Encourage the Auditing Organisation to get authorized/ recognized • As MDSAP grows, so will RA participation • Choice of MDSAP Auditing Organisation

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Some RA-specific benefits • Australia – TGA will take into account MDSAP audit reports for QMS when:

– deciding whether to issue or maintain Conformity Assessment Certificates that are required for “combination” products Medicine / Device, Animal Origin / Device etc.

– auditing applications for ARTG Entry when evidence of compliance with the QMS requirements of a conformity assessment procedure is required.

– when EC Conformity Assessment Certification for QMS is not available.

• Brazil – program outcomes and reports used as key inputs into ANVISA’s pre­market and post-market assessment procedures

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Some RA-specific benefits • Canada – will accept either MDSAP or CMDCAS certificates for obtaining Class

II, III or IV medical device license. Full transition to MDSAP expected to occur by 2019

• Japan – may accelerate the Marketing Authorisation and reduce post-market burden (still under evaluation)

• United States – will accept MDSAP audit reports as substitute for routine inspections

• See also MDSAP Question and Answer document on FDA MDSAP website! 35

WHO Prequalification for diagnostic devices

• MDSAP audits may be recognized as acceptable evidence of QMS compliance with international regulations, resulting in an abbreviated or waived site audit by WHO.

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How to participate • Any medical device manufacturer is eligible • Participation is not initiated through a Regulatory Authority! • Identify a participating MDSAP Auditing Organisation - FDA MDSAP website.

– Any current CMDCAS recognized registrar – Many may also be able to provide audit and assessment for EC Certification.

• Inquire if the AO has progressed sufficiently in the assessment process to accept applications for an MDSAP audit.

• An RA’s routine audit / inspection program will not be suspended until an AO notifies MDSAP of a manufacturer’s participation in the program. – Note that “for cause” audits may still be conducted by RAs

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Feedback mechanisms • IMDRF Consultations

• MDSAP Participation Surveys

• Email: – MDSAP@tga.gov.au – MDSAP.ATENDIMENTO@anvisa.gov.br – QS_MDB_HC@hc-sc.gc.ca – MDSAP@pmda.go.jp – MDSAP@fda.hhs.gov

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Resources – MDSAP Website http://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/default.htm

– MDSAP Question and Answer Document http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf

– Canadian Medical Device Conformity Assessment System (CMDCAS)-Recognized Certification Bodies http://www.scc.ca/accreditation/management-systems/cmdcas/cmdcas-recognized-certification-bodies

– IMDRF Consultations http://www.imdrf.org/consultations/consultations.asp#current

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Resources • CDRH Learn:

– http://www.fda.gov/Training/CDRHLearn/ucm372921.htm

• MDSAP Documents: – http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm

• IMDRF Final Documents: – http://www.imdrf.org/documents/documents.asp

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Questions