Experience of IMDRF Experience of IMDRF Experience of IMDRF Experience of IMDRF Plenary 2: Collaboration and harmonization Plenary 2: Collaboration and harmonization Plenary 2: Collaboration and harmonization Plenary 2: Collaboration and harmonization in the field of medical devices in the field of medical devices in the field of medical devices in the field of medical devices Madoka Murakami, PhD Pharmaceuticals and Medical Devices Agency (PMDA) Japan
Transcript
Experience of IMDRFExperience of IMDRFExperience of IMDRFExperience of IMDRFPlenary 2: Collaboration and harmonizationPlenary 2: Collaboration and harmonizationPlenary 2: Collaboration and harmonizationPlenary 2: Collaboration and harmonization
in the field of medical devicesin the field of medical devicesin the field of medical devicesin the field of medical devices
Madoka Murakami, PhD
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan
Agenda
• History of Medical Device Regulatory Harmonization
• IMDRF
• MDSAP Pilot
History of Medical Device Regulatory Harmonization (1)History of Medical Device Regulatory Harmonization (1)History of Medical Device Regulatory Harmonization (1)History of Medical Device Regulatory Harmonization (1)
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1989: Quality Standard Conference (Paris)
1990: 1st Global Medical Device Conference (DC)
1991: 2nd Global Medical Device Conference (San Diego)
1992: 3rd Global Medical Device Conference (Nice)
Regulatory Authorities in Canada, EU, Japan, US started discussions
to establish medical device regulatory harmonization platform with
regulators and industry
Start of ICDRA: 1980
Launch of ICH: 1990 based on a discussion at ICDRA in 1989
• Global Harmonization Task Force (GHTF): created in 1992 as voluntary harmonization initiative comprised of regulators and industry from Europe, US, Japan, Canada and Australia
• Purpose: encourage convergence in regulatory requirements, practices and systems to promote:
• safety, effectiveness/performance and quality of medical devices
• technological innovation, and
• international trade
• Mechanism: create guidance documents on basic regulatory framework by 5 study groups
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History of Medical Device Regulatory Harmonization (2)History of Medical Device Regulatory Harmonization (2)History of Medical Device Regulatory Harmonization (2)History of Medical Device Regulatory Harmonization (2)
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1993: GHTF Study Groups (SGs)
SG1 Premarket Evaluation
SG2 Post-market Surveillance/Vigilance
SG3 Quality Systems
SG4 Auditing
1996: Asian Harmonization Working Party (AHWP) was established
2000: Establishment of GHTF Steering Committee
2001: GHTF training for APEC
2004: GHTF SG5 “Clinical Evaluation”
2011: The GHTF Regulatory Model
2012: Termination of GHTF, launch of IMDRF
History of Medical Device Regulatory Harmonization (3)History of Medical Device Regulatory Harmonization (3)History of Medical Device Regulatory Harmonization (3)History of Medical Device Regulatory Harmonization (3)
Training
Conference
�GHTF Regulatory Model
�Definition
�Essential Principle
�NCAR exchange program
�Quality Management System (QMS)
�Regulatory Auditing of QMS
�Clinical Evaluation
etc.
AHWP, APEC, PAHO, LAWP
13 conferences through 20 years
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GHTF guidance Document (41 available)
Accomplishments of GHTFAccomplishments of GHTFAccomplishments of GHTFAccomplishments of GHTF
Regulatory
Decision
Regulation,
Procedures
Technical
Requirements
Level of Harmonization Level of Harmonization Level of Harmonization Level of Harmonization
ICH
GHTF
Dr. Toshiyoshi Tominaga’s concept
IMDRF
Agenda
• History of Medical Device Regulatory Harmonization
• IMDRF
• MDSAP Pilot
Management Committee member
Founding member of GHTF Brazil Russia China
APEC AHC LSIF
Official Observer Affiliate Organization
Singapore
The roles of IMDRF Chair and Secretariat rotate annually:
2012 – Australia, TGA
2013 – European Union, European Commission
2014 – USA, Food and Drug Administration
2015 – Japan, MHLW/PMDA
2016 – Brazil, ANVISA
2017 – Canada, Health Canada
2018 – China, CFDA
2019 – Russia, Roszdravnadzor
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IMDRF Work Items IMDRF Work Items IMDRF Work Items IMDRF Work Items
1. Medical Device Single Audit Program (MDSAP) (completed)
2. Unique Device Identification (UDI) system (Completed)
3. National Competent Authority Report (NCAR) Exchange
4. Regulated Product Submission (RPS)
5. Software as a Medical Device (SaMD)
6. Patient Registries
7. Adverse Event Terminology and Coding
8. Good Regulatory Review Practice (GRRP); Competence and Training Requirements for Pre-market Reviewers and Product Specialist
9. Improving the quality of international medical device standards for regulatory use 11
Agenda
• History of Medical Device Regulatory Harmonization
• IMDRF
• MDSAP Pilot
Overview of MDSAP processOverview of MDSAP processOverview of MDSAP processOverview of MDSAP process
2. Assessment/Recognition
4. Audit report/Certification
5. Data uploading
3. Submission for Audit
6. Data review
Auditing Organization
Manufacturer
1. Submission for
Recognition
IT system
MDSAP member countries
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Conformity to QMS requirements of
all member countries are assessed
in one audit
7. Utilization of Audit ReportConfidential Arrangement among members
IMDRF Documents for MDSAPIMDRF Documents for MDSAPIMDRF Documents for MDSAPIMDRF Documents for MDSAP
N3: Requirements for AOs for RA Recognition
N4: Competence and Training Requirements for AOs
QMS
Auditing Organization
Regulatory Authority (RA) N6: RA Assessor Competence and Training
Requirements
Manufacturer
QMS Audit/
Certification
Auditing Organization (AO)
Assessment/
Recognition
N5: RA Assessment Method for the Recognition and
Monitoring of AOs
N8: Guidance for RA Assessors on the Method of
Assessment for MDSAP AOs
N11: MDSAP Assessment and Decision Process for
the Recognition of an AO
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N24: Medical Device Regulatory Audit Reports
First Recognition Annual SurveillanceRe-recognition/3
years
Stage 1: Document
Assessment of HQ
Stage 2: On-site
Assessment of HQ
Observation of Audit
before Recognition (3
times)
Surveillance
Assessment of HQ
Observation of Audit
(one time per year)
Document
Assessment
Re-recognition
Assessment of HQ
Observation of Audit
Example of RA Assessment for Recognition of AOsExample of RA Assessment for Recognition of AOsExample of RA Assessment for Recognition of AOsExample of RA Assessment for Recognition of AOs
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Stage 2: On-site
Assessment of Branch
Office
Stage 2: On-site
Assessment of Branch
Office
Stage 2: On-site
Assessment of Branch
Office
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