Update of Medical Device Single Audit Program (MDSAP) activities December, 2013 Hideyuki Kondo Office of Medical Device Evaluation, Ministry of Health Labour and Welfare, Japan
Disclaimer
The views and opinions expressed in this presentation and on the following slides are those of the presenter and not necessary those of other stakeholders.
Agenda 1. MDSAP WG in IMDRF 2. MDSAP Pilot 3. Expectation in Japan
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MDSAP is one of key activities in IMDRF The International Medical Device Regulators Forum (IMDRF) recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the Medical Device Single Audit Program (MDSAP). 4
Much progress of MDSAP WG in IMDRF As a result of the latest IMDRF MC meeting, the following progresses have been achieved: - 4 documents have been finalized; 1. N3: Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition 2. N4: Competency and Training Requirements for Auditing Organizations 3. N5: Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations 4. N6: Regulatory Authority Assessor Competency and Training Requirements
- New activities will be started; 1. 2.
Regulatory Authority Assessment Method Guidance Auditing Organization Assessments, Recognition and Remediation
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Overview of Auditing Organization system Recognizing Regulatory Authority (Assessor) Assess Auditing Organization (Auditor) Audit Manufacturer
N5: Assessment method N6: Competency ISO 17021 N3: Requirements N4: Competency - ISO 13485: 2003 - Brazilian Good Manufacturing Practices (RDC ANVISA) - Quality System Regulation (21 CFR Part 820) - J-QMS etc.
Agenda 1. MDSAP WG in IMDRF 2. MDSAP Pilot 3. Expectation in Japan
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History of MDSAP Pilot The heads of the regulatory agencies of Australia, Brazil, Canada and the United States signed a Statement of Cooperation on the MDSAP Pilot at the Head of Agency Summit in Manaus, Brazil in November 2012. Japan (MHLW and PMDA) recently became official observers and active participants in the Pilot Program’s Regulatory Authority Council and subject matter expert groups. MDSAP Pilot announcement was released in October 2013. (http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM372066.pdf)
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Overview of MDSAP Pilot Recognizing Regulatory Authority (Assessor) USA
Canada
Australia
Brazil
(Japan)
IT Portal
Assess Auditing Organization (CMDCAS register) USA
Canad a
Austral ia
Brazil
Manufacturer
Single Audit
Objectives of MDSAP Pilot (1/2) To operate a single audit program that provides confidence in program outcomes. To enable the appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on industry. To promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. 10
Objectives of MDSAP Pilot (2/2) To leverage, where appropriate, existing conformity assessment structures. To promote, in the longer term, greater alignment of regulatory approaches and technical requirements globally based on international standards and best practices. To promote consistency, predictability and transparency of regulatory programs
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MDSAP Pilot Audit Process (1/2) The MDSAP audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the requirements of medical devices – quality management systems: – ISO 13485:2003 – Brazilian Good Manufacturing Practices (RDC ANVISA) – Quality System Regulation (21 CFR Part 820) 12
MDSAP Pilot Audit Process (2/2) AND other specific requirements of medical device regulatory authorities participating in the Pilot MDSAP program such as: - registration, - licensing, - adverse event reporting and more.
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Summary of MDSAP Pilot (1/2) Who will be possible AO? Accredited organizations/registrars currently utilized in the Health Canada CMDCAS Program. When will the pilot be started? From January, 2014. 3 years project. How will Regulatory Authorities oversight AOs? Achievements of MDSAP WG in IMDRF as well as other documents will be utilized.
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Summary of MDSAP Pilot (2/2) How can medical device manufacturers participate? The MDSAP project plan targets the review of applications every six months. Where can I find more information? the IMDRF MDSAP documents that can be found at: http://www.imdrf.org/ Other documents will be founded at the FDA website. (e.g. http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm) 15
Agenda 1. MDSAP WG in IMDRF 2. MDSAP Pilot 3. Expectation in Japan
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Third Party Certification system in Japan MHLW
Assess/Register
ISO 17021 ISO 17065
Certification Body Audit/ Product Review Manufacturer
J-QMS Certification Standards Essential Principle
Class II medical devices with certification standards are certified by Certification Body in Japan GHTF Classification
Class extremely low risk A
PAL classification Category
Pre-market regulation
Japanese MD Nomenclature
General MDs (Class I)
Self declaration
1,195
X-Ray film
Class low risk MRI, digestive B
Controlled MDs (Class II)
Third Party Certification
catheters
Class medium risk artificial bones, C dialyzer
Class high risk pacemaker, artificial D
Specially Controlled MDs (Class III & IV)
1,799 (1,367 for 3rd Party)
Minister’s Approval (Review by PMDA)
756
342
heart valves
As of July, 2013
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Scope of Third Party Certification will be expanded GHTF Classification
Class extremely low risk A
PAL classification Category
Pre-market regulation
Japanese MD Nomenclature
General MDs (Class I)
Self declaration
1,195
Controlled MDs (class II)
Third party Certification
1,799 (1,367 for 3rd Party)
X-Ray film
Class low risk MRI, digestive B catheters
Class medium risk artificial bones, C dialyzer
Class high risk pacemaker, artificial D heart valves
Specially Controlled MDs (class III & IV)
756 Minister’s Approval (Review by PMDA)
342 19
Third party certification system will be modified to make it more reliable 1. Supervision for third parties by regulatory authorities will be strengthened. 2. Quality of reviewers and auditors will be ensured. 3. More information on QMS will be reported to regulatory authorities. N3, N4, N5 and N6 implementations? 20
Thank you
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