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Presentation: Medical Devices Single Audit Program (MDSAP)

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016


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  • Presented by: Keith M Smith
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.


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, TGA

ARCS Scientific Congress Canberra 2016, 10 - 11 August 2016

Slide 1 - Objectives

  • TGA's International Programs
  • MDSAP Pilot
  • Audits
  • Assessments
  • Implementation
  • Participation
  • Questions

Slide 2 - 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

Slide 3 - IMDRF MDSAP model

Slide 4 - 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

Slide 5 - Concept

Triangular flow chart labelled Concept. Regulatory Authorities at the top, Auditng Organisations bottom left, Medical Device Manufacturers bottom right. - Regulatory Authorities: - Arrow pointing to Auditing Organisations with the words 'Assess and recognize'. - Arrow pointing to Medical Device Manufacturers with the words 'Make regulatory decisions - Market Authorisation'. Auditing Organisations: - Arrow pointing to Regulatory Authorities with the words 'Share audit report and certificate. - Arrow pointing to Medical Device Manufacturers with the words 'Audit and certify'.

Slide 6 - MDSAP pilot

Slide 7 - 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

Slide 8 - 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

Slide 9 - MDSAP pilot - Governance and operations

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

Slide 10 - 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

Slide 11 - 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)

Slide 12 - MDSAP audits by auditing organisations

Slide 13 - 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

Slide 14 - 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

Slide 15 - 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

Slide 16 - MDSAP audit model

  • Sequence to audit QMS processes forISO 13485 and Regulatory Requirements

Flow chart of the MDSAP audit model. A shape labelled 'Risk Management' encloses a shape labelled 'Purchasing', which encloses the following: Management, which points down to 'Measurement, Analysis and Improvement', which points down to 'Design and Development', which points down to 'Production and Service Controls', which points back to 'Management'. The following also have an arrow pointing outside the main part of the diagram: Management points to Device Marketing Authorisation and Facility Registration. Measurement, Analysis and Improvement points to MD Adverse Events and Advisory Notice Reporting Design and Development points to Device Marketing Authorisation and Facility Registration.

Slide 17 - 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

A cross-hair diagram. Impact is on the Y-Axis and Occurence on the X-axis. The top half is labelled 'Direct Cl 6.4 - 8.5.3' and contains two boxes labelled '3' and '4'. The bottom half is labelled 'Indirect Cl 4.1-6.3' and contains two boxes labelled '1' and '2'. The left column (boxes 3 and 1) are labelled 'First' and the right column (boxes 4 and 2) are labelled 'Repeat'.

Slide 18 - 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.

Slide 19 - MDSAP - Manufacturer Audit Program

Audit MDSAP - Manufacturer Audit Program

Initial Audit

Surveillance Audit

Recertification Audit

Special Audit, Unannounced Audit, Regulatory Authority audit
Audit Activities  
Stage 1
Documentation Review

Stage 1
(as needed)Documentation Review

Stage 1
(as needed)Documentation Review

Stage 2
On-Site Full Audit
Review of changes, management process, M,A&I, registration, authorisation, etc. Review audit reports, corrections/corrective actions, tasks not covered in previous audits

Slide 20 - MDSAP assessments byregulatory authorities

Slide 21 - 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

Slide 22 - RA assessment method: Processes

  • Management (including Impartiality)
  • Measurement, Analysis and Improvement
  • Competency Management
  • Audit and Certification Process
  • Information Management


Slide 23 - MDSAP - Auditing Organisation Assessment Program

Assessment MDSAP - Auditing Organisation Assessment Program

Initial Assessment

Surveillance Assessment

Re-Recognition Assessment
Assessment Activities Application Review

Stage 1 Assessment including Documentation Review

Stage 1 Assessment including Documentation Review for changes

Stage 2 On-Site Assessment (Head Office)

Surveillance On-Site Assessment (Head Office)

Re-Recognition On-Site Assessment (Head Office)

3 Witnessed Audits

1 Witnessed Audit

1 Witnessed Audit

On-Site Assessment of all Critical Locations (as necessary)

1 Witnessed Audit per Critical Location per Assessment Cycle (as necessary)

1 Witnessed Audit per Critical Location per Assessment Cycle (as necessary)

Slide 24 - 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

Slide 25 - MDSAP implementation

Slide 26 - Timeline

2012 - 2013 - Pre-Pilot: IMDRF Model and Pilot Development. 2014 - 2016 - MDSAP Pilot: CMDCAS Registrar Assessment / Witness Audits. 2017 - 2018 Transition: ISO13485:2003 to 2016, CMDCAS to MDSAP. 2019 - 2020 - Full MDSAP: Global System??

Slide 27 - 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.

Slide 28 - 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

Slide 29 - 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
  • 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

Slide 30 - MDSAP participation

Slide 31 - Participating manufacturers (June 2016)

A bar graph displaying participating manufacturers from Quarter 3 2014 to July 2016. Number of sites added and cumulative totals are both displayed.

Slide 32 - 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

Slide 33 - 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

Slide 34 - 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 pre-market and post-market assessment procedures

Slide 35 - 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!

Slide 36 - 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.

Slide 37 - 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

Slide 38 - Feedback mechanisms

Slide 39 - Resources

Slide 40 - Resources

Slide 41 - Questions

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