zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Medical Devices - - PowerPoint PPT Presentation

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Objectives

• TGA’s International Programs
• IMDRF MDSAP Model
• MDSAP Pilot
• Audits
• Assessments
• Implementation
• Participation
• Questions

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA IMDRF MDSAP Model

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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 zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Pilot

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Pilot – Governance and Operations

• Regulatory Authority Council (RAC)
• International Subject Matter Expert (SME) Working Groups

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Audits by Auditing Organisations

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP audit model

• Sequence to

audit QMS processes for ISO 13485 and Regulatory Requirements

ent anagem M k s i R ng i has c ur P 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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 Impact

Indirect

Cl 4.1 – 6.3

Direct

Cl 6.4 – 8.5.3

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

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 udi A

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

ie it iv t c A t

Review audit reports, Stage 2 Review

• f changes,

udi

corrections/corrective

A

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

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

MDSAP Assessments by Regulatory Authorities

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA RA assessment method: Processes

Outsourcing

• Management

(including Impartiality)

• Measurement, Analysis

and Improvement

• Competency Management
• Audit

and Certification Process

• Information Management

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Assessment

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) Assessment Activities 23

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

MDSAP Implementation

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Timeline

IMDRF Model and Pilot Development CMDCAS Registrar Assessment / Witness Audits ISO13485:2003 to 2016, CMDCAS to MDSAP

Global System??

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA

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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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

• n 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

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Participation

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Participating manufacturers (June 2016)

6 9 10 25 11 23 24 10 6 15 25 50 61 83 107 117 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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

• f 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 pre-

market and post-market assessment procedures

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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!

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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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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zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 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