Medical Device Single Audit Program (MDSAP) Copyright 2014 BSI. All rights reserved.

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1 Medical Device Single Audit Program (MDSAP)

2 International Medical Device Regulatory Forum (IMDRF) IMDRF Management Committee (MC) regulators: Australia, Brazil, Canada, China, the European Union, Japan and the United States of America Representatives of the World Health Organization (WHO) Regulators from the Russian Federation, Mexico, Asian Harmonization Working Party (AHWP) participate as affiliate organization 2

3 IMDRF Work Groups National Competent Authorities Report Exchange Program Roadmap for Implementation of Unique Device Identification system Medical Device Single Audit Program List of Recognized Standards Regulated Product Submission 3

4 MDSAP Goals Recognize Auditing Organizations (AO) Single Audit by AO would: benefit patient health and patient access leverage regulatory resources minimize medical device manufacturing disruptions due to multiple regulatory audits provide global benefit both on short term goals and longer term goals by IMDRF regulators 4

5 MDSAP- Statement of Cooperation (November 2012) Australia Therapeutics Goods Administration (TGA) Brazil Agência Nacional de Vigilância Sanitária (ANVISA) Canada Health Canada/Santé Canada United States of America Food and Drug Administration (FDA) 5

6 MDSAP Manufacturer Audit Criteria GMP requirements of the regulatory authorities One audit to address all Certification will be required Health Canada US FDA Brazilian ANVISA Australian TGA AO Audit 6

7 MDSAP Manufacturer Audit Cycle The initial Audit is followed by a partial Surveillance Audit in each of the following two years and a complete Re-audit, also referred to as a Recertification Audit in the third year Special Audits, Audits Conducted by Regulatory Authorities, and Unannounced Audits are potential extraordinary audits that may occur at any time within the audit cycle. 7

8 How Regulators will use MDSAP reports Australia: The Therapeutics Goods Administration TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports. Brazil: The Brazilian National Health Surveillance Agency ANVISA will utilize the outcomes of the program, including the reports, to constitute an important input on ANVISA s pre-market and post-market assessment procedures, providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues. Canada: Health Canada HC will use a MDSAP audit as part of their Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Upon the successful conclusion of the pilot, Health Canada's intent is to implement the Medical Device Single Audit Program, as the mechanism to achieve regulatory compliance for quality management system requirements in Canada. 8

9 How Regulators will use MDSAP reports United States: U.S. Food and Drug Administration s Center for Devices and Radiological Health FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, this MDSAP program would not apply to any necessary preapproval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device. Japan s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the Pilot Program s Regulatory Authority Council and subject matter expert groups. 9

10 MDSAP Pilot January 1, 2014 Recognition of initial participating Auditing Organizations June 1, 2014 Some Auditing Organizations ready to start auditing medical device manufacturers and more will be added as the pilot progresses. 10

11 Find out more

12 Any Questions 12