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 1

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 2

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA IMDRF MDSAP Model 3

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 4

CONCEPT zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Regulatory Authorities Make and regulatory Assess Share audit recognize decisions – report and Market Authorisation certificate Auditing Medical Device and certify Audit Organisations Manufacturers 5

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Pilot 6

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 7

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 8

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Pilot – Governance and Operations • Regulatory Authority Council (RAC) • International Subject Matter Expert (SME) Working Groups 9

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 10

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) 11

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP Audits by Auditing Organisations 12

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 13

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 14

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 15

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA MDSAP audit Device Marketing Management model Authorisation and Facility Registration - Sequence to audit QMS Measurement, Measurement, ent MD Adverse Events Analysis and processes for Analysis and and Advisory Notice anagem ng Reporting Improvement Improvement ISO 13485 and i has Regulatory c Device Marketing Design and ur M Authorisation and Requirements P Development k Facility Registration s i R Production and Service Controls 16

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Nonconformity grading • GHTF N19 - Nonconformity Cl 6.4 – 8.5.3 3 4 Grading System for Regulatory Direct Purposes • NCs are assigned a grade, 1 to 5 Impact • Calculated in two steps – Grading Matrix Cl 4.1 – 6.3 1 2 Indirect – Escalation Rules  No Documented Process, +1  Release of nonconforming medical device, +1 First Repeat Occurrence 17

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. 18

MDSAP – Manufacturer Audit Program t udi Initial Audit Surveillance Audit Recertification Audit A Special Audit, Unannounced Audit, Regulatory Authority audit – (as needed) – (as needed) Stage 1 Stage 1 Stage 1 Documentation Review Documentation Review Documentation Review s ie it iv t Review audit reports, c A Review of changes, Stage 2 t corrections/corrective udi On-Site Full Audit management process, actions, tasks not A M,A&I, registration, covered in previous authorisation, etc. audits 19

MDSAP Assessments by Regulatory Authorities zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA 20