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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

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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

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Timeline

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Thank Youfor Your Attention

Thank Youfor Your Attention