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Medical Device Review at TFDA 2012 APEC Advanced Workshop of Good Review Practice on Medical Products Ming-Che Wang, Ph.D Director, Division of Medical Devices Center for Drug Evaluation Chinese Taipei

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Page 1: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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

Page 2: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

2

Regulatory Frameworkof Medical Devices

Page 3: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 4: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 5: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

5

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

Page 6: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 7: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 8: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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Regulatory System

PostmarketSurveillance

Premarket Evaluation

Source Control

Product Regulation

GMP/QSD

RegistrationMonitoring

Page 9: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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)

Page 10: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 11: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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Premarket Approval

Page 12: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 13: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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

Page 14: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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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.

Page 15: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

15

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.

Page 16: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

16

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

Page 17: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

17

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…)

Page 18: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

18

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

Page 19: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

19

Postmarket Surveillance

Page 20: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

20

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

Page 21: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

21

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)

Page 22: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

22

Future Goals

Page 23: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

23

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

Page 24: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

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

Page 25: Medical Device Review at TFDA · Medical Device Review at TFDA ... PSUR Voluntary recall notification Inspection Active voluntary reporting by mfr. Flow Chart of Medical Device Reporting

25

Thank Youfor Your Attention

Thank Youfor Your Attention


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