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Medical Device Review at TFDA
2012 APEC Advanced Workshop of Good Review Practice on Medical Products
Ming-Che Wang, Ph.DDirector, Division of Medical Devices
Center for Drug EvaluationChinese Taipei
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Regulatory Frameworkof Medical Devices
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Food and Drug Administration (TFDA) inaugurated on Jan. 1, 2010
TFDA supersedes 4 bureaus– Bureau of Food Safety– Bureau of Pharmaceutical Affairs– Bureau of Food and Drug Analysis– Bureau of Controlled Drugs
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Risk Management
and Quality
Assurance
Consolidated Food and Drug Safety Regulatory System
TFDA
Food Drug
Controlled Drug Research &Analysis
Center for Regional
Administration
Medical Device Cosmetics
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Organization Diagram of Division of Medical Devices and Cosmetics
Director
Senior Technical Specialist
Section for Medical
Devices Safety & Quality Control
Section for Medical Devices Project
Management
Section for Medical Devices
Consultation & Clinical
Trials
Section for Medical Devices
Registration(I)
Section for Medical Devices
Registration (II)
Section for Cosmetics
Senior Technical Specialist
Deputy Director
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Roles of Regulatory Authorities
• Public Health Protection– Gate keeper
• Health Promotion Through Facilitating Innovation– Efficient and transparent review process– International harmonization of regulation– Consultation mechanism
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A Total Product Life-Cycle Approach of Medical Device Regulation
Request for DesignationConsultation
IDEGLP/GTP
GCP
GMPPost-marketing Surveillance
GRevP
Obsolescence
Concept Prototype Preclinical
Clinical
ManufacturingRegistrationMarketing
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Regulatory System
PostmarketSurveillance
Premarket Evaluation
Source Control
Product Regulation
GMP/QSD
RegistrationMonitoring
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Implementation of Medical Device GMP
• Effective on February 10, 1999
• Third party inspection (contracted by TFDA)
• Domestic manufacturers: site inspection
• Importing manufacturers: quality system document (QSD) review (may also apply for overseas site inspection)
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Statistics of GMP/QSD by Domesticand Imported Manufacturers
QSD (imported)2,931 (85%)
GMP (domestic)504 (15%)
• Updated 2012.03.31
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Premarket Approval
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Class 1(42%)
On-siteregistration
Class 2(50%)
Administrative documents
+Technical
documents
Class 3(8%)
Administrative documents
+Technical
documents+
Clinical reports
GMP GMP GMPLow risk High risk
Risk-Based Registration Requirements
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Process for Registration of Medical Devices
Manufacturing FacilityGMP/QSD Application
TFDA
Review Center
Medical Device Advisory
Committee (AC)
GMP Auditing/QSD Review
GMP/QSD Compliance
Letter
License Granting
ProductLicense Application
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Number of Medical Device Licenses
Up to Dec.31, 2011, a total of 33,571 licenses were granted. It increases at a rate of >10% per year.
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Reform of Pre-market Approval
Streamlined Review
Simplify pre-market review.Shorten time to market for emerging medical devices.
•Waive testing reports for US FDA-cleared Class 2 devices.
•Summary forms of testing are accepted for certain Class 2 devices.
• Waive AC meeting for certain Class 3 devices.
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Recently Implemented Policies (I)
• “Medical device substantial equivalence decision making flowchart” issued
• Clinical reports of Class 2 new medical devices can be waived under certain circumstances
• Class 3 IVD type testing waived except some high risk items, such as blood screening products
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Recently Implemented Policies (II)
• Implemented Pre-IDE and Pre-PMA consultation system
• Seed personnel training programs for establishing regulatory consultation network
• Public notice of guidance documents (Hyaluronic acid implants, Drug-eluting stent…)
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Consultation Program
Consultation hotline
Medical DevicesWorkshops
Online courses for beginners
online Q&A
Project-based consultation
pre-IDE/pre-PMAConsultation
Education for Seed personnel
Consultation for early stage R&D
General consultation
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Postmarket Surveillance
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National ADR Reporting Center
Consumer Medical Personnel
Local Health Authority
ADRProduct defect
Investigation, seizure, and sampling of non-compliant products
Assigned tasks
ADRProduct defect
Case reports
Active voluntary reporting by mfr.
TFDA
ManufacturerSAEPSURVoluntary recall notification
Inspection
Active voluntary reporting by m
fr.
Flow Chart of Medical Device ReportingSafety information
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Global Surveillance Participation
• Daily Monitoring from internet and global press (FDA, MHRA, TGA...)
• Member of GHTF National Competent Authority Report (NCAR)
• Joined AHWP Safety Alert Dissemination System (SADS)
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Future Goals
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Pre-market Evaluation
• Strategy– Online registration of Class 1 devices– Implementation of STED
• Scheduled for Class III devices in 2013
– Reclassification– Implementation of good review practice (GRevP)
2012 2013 2014 2015 2016 2017 2018
----short-term-----------long-term--------------------------------------------------
Timeline
Post-market Regulation
• Strategy– Strengthen license re-evaluation– Construct Total Product Life Cycle (TPLC)– Enhance illegal medical device inspection– Continue global surveillance activity
2012 2013 2014 2015 2016 2017 2018
----short-term-----------Long-term--------------------------------------------------
Timeline
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Thank Youfor Your Attention
Thank Youfor Your Attention