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Development of Medical Devices and Regulation

Updates in Chinese Taipei

2012 AHWP Meeting

Huihua K Chiang, Ph.D.Huihua K Chiang, Ph.D.Office of Science and TechnologyOffice of Science and Technology

Executive Yuan, ROC Executive Yuan, ROC 1

Taiwan Medical Device Clusters

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2

齒顎矯正微骨釘 微創椎弓根螺釘固定系統 橈動脈止血器 鈦夾止血鉗 固定夾板

New Medical Device Developments in TaiwanContributed from: companies, schools, research institutes/centers.

3(ITRI, Rapid Prototyping of Medical Devices)

Taiwan Biotech Status (2010)

Category

Applied Biotech

Drugs Medical Devices

Revenue (Billion NT$)

63 73 93

# Companies 405 370 580(85% GMP)

# Staffs 10,250 18,500 25,800

Import：Export 58:42 79:21 57：43

Annual Growth 9% 2% 7%

資料來源：DCB，IEK，經濟部生技醫藥產業發展推動小組，2011年。

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Product Company 2011 Revenue

Blood PressureMeter

百略Microlife

4.3 (B NT$)

Dialysis佳醫

Excelsior Medical3.2

Contact Lens精華光學

Ticon3.4

Blood GlucoseMeter

五鼎ApexBio

1.9

IEK

Taiwan Medical Devices Taiwan Medical Devices

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Taiwan Medical Device Markets

2011 Exports 2011年 Imports

資料來源：Taiwan Custom, IEK(2012/08)6

手術與治療用

醫療器材

19%

輔助與彌補用

醫療器材

33%

體外診斷用醫

療器材

20%

Others 27%

Taiwan Medical Device Import/Export Analysis

Taiwan Custom；IEK(2012/08)

diagnosis

and

monitoring

9%

surgery and

treatment

devices

40%assisted

devices

20%

IVD devices

13%

Others 18%

2011

Import

2011Export

7

Medical device product license(醫療器材許可證)

國產,

7129,20%

輸入,

27732,80%

Medical device product license, increase 10% anually。

Class II

17403(50%)

Class I

16412(47%)

Class III

1046(3%)

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99

The journey from medical device candidate to full-scale production and marketing are highly regulated by Regulatory

Authority 9

1010

Medical Device Life Cycle Regulations

Request for Designation

ConsultationIDE

GLP/GTP

GCP

GMPPost-Market Surveillance

Design Concept Prototype Preclinical Testing

ClinicalTrial

ManufacturingPremarket RegistrationMarketing

GRevP

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Countries Regulate Medical DevicesThe list is growing …..

• Argentina• Australia*• Belarus• Brazil• Canada*• China• Colombia• Ecuador• E.U.*• Guatemala• India• Japan*• Kazakhstan• Korea

• Malaysia• Mexico• Paraguay• Peru• Philippines• Romania• Russia• Saudi Arabia• South Africa• Singapore• Taiwan• Thailand• USA*• Venezuela

* GHTF Founding Members11

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Major Global Regulatory Systems -US FDA-based Approach

- CFR based on known risk- Review by FDA for Safety & Effectiveness

- EU Based Approach- Rules-Based- Review by NBs for Safety (you select & pay)

- In Between- More like US system China, Taiwan, Japan, Korea- More like EU system Canada, Australia

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Global Harmonization Task Force (GHTF)and International Medical Device

Regulators Forum (IMDRF)• 1992 – GHTF: industry and regulators.

Aims: global harmonization.• 2011 – IMDRF: regulators-only.

Aims: global harmonization / convergence.• From harmonization to convergence.

(culture, legal, political situations).

• “Harmonized” medical device global regulation is currently lacking.

• Need multiple submission to each country of interest.13

Strategies for Global Market Access

• Consider where is “global” to a company.• Know the law and regulation of the country.• Understand the strengths/weakness of the

country’s regulatory system.• Map out regulatory strategy.• Determine the internal / external resources

needed for product registration in the country.

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Comparison – US vs. Asian SystemCountry Regulatory

Body/LawClass (Risk Based)

MarketApproval

GMP System

Other requirements

United States

FDA/CDRHMD amend. to FD&C Act

Class I, II, IIISafety & Effectiveness(S & E)

510(k) exempt510(k)PMA

QSR 21 CFR 820; enforced by FDA

Annual regist. & listingMDR

China SFDA + Prov.FDA + Mun. FDAMedical Device Law, 2000

Class I, II, IIIS & E

Class III + import SFDAClass II PFDAClass I Mu.FDA

China GMP Regulation, enforced by Prov. FDA

Re-regist. every 4 years

Domestic sponsor

Taiwan Taiwan FDA (TFDA)Pharmaceutical Affairs Law

Class I, II, III,S & E

Registration –TFDA + CDE + Adv. Committee

ISO 13485; enforced by non-gov third-party inspectors

Re-regist. every 5 years

Korea Korea FDA (KFDA)Medical Device Act 2003

Class I, II, III, IVS & E

Class I – Premarket notificationClass II, III, IV –Premarket approval

Korea GMP, enforced by KFDA

Domestic sponsor + country of origin approval

Japan MHLW/PMDAPharmaceutical Affairs Law

Class I, II, III, IVS & E

Self certification (I)3rd party certif. (II)Minister approval (II, III, IV)

Japan GMP (adapt ISO 13485, 2003)

License for Product + Company +Manuf. plant

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Service

Innovation

Consumer safety protection

Accelerate development of medical product

International cooperation

Robust legal system

New Era of Medical Device Regulation

Ethics &Integrity

Efficiency

(TFDA)16

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Development of Medical Devices Regulation

Comprehensive consultation

network

Improve clinical trial environment

Personnel training

•Revision of clinical trial regulations•Establish clinical trial information platform•Training for reviewers and inspectors•Quality control of clinical trials

•Systematic promotion and education for regulation•Facilitate regulatory pathways for high-risk medical devices

•Establish TFDA staff college•Providing training courses for industry

17(TFDA)

16.7

29.2 33.3

2010 2011 2012

Effective project consultation for medical devices

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Domestic class III device product licensesfrom 24 to 32, a 33% gain.

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Future Medical Device Regulatory Framework

Post-marketregulation

Pre-marketApproval

Quality System for Manufacturer

Supplier and product

supply chain regulation

Past：Pre-market approval

Future：Post-market regulation

Facilitating innovation(regulatory consultation)

Medical DeviceMedical DeviceRegulationRegulation

GVP

GDP (TFDA)

Improve Review Process

Class II and III devices CasesReview Time

(Days)Approval Rate

( % )2010 2318 126 752011 2613 82 88

Margin of Change (%) +12.7 -35 +17

New medical devices CasesReview Time

(Days)Approval Rate

( % )2010 66 192 642011 71 131 72

Margin of Change (%) +7.6 -31.8 +12.5

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IEK estimates: shortening the registration by 30 days may increase 7 billion NT$ of domestic output value for medical device industry

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Taiwan new medical device – case 1

Osteochondral Repair Technology (兩相材料軟硬骨關節修復技術 ) World 1st clinical trial device. 1st in class (國產研發) ， Milestone for TFDA (獨立自主審查)

， Indication in cartilage repair.

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Taiwan new medical device – case 2

Obstructive Sleep Apnea Negative Pressure Airway Dilation Push tongue and soft palate forward 1st in class (國產研發) ， Milestone for TFDA (獨立自主審查)

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New medical device - case 3

Multi-functions POC device【Vsensor】 Engineered semi-conductive antibody: sensitive detection of: hapten,

proteins, or viral antigen. 1st in class (國產研發) ， Milestone for TFDA (獨立自主審查)

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Acknowledgements:

Dr. Lin CS, Lin Associates.Dr. Shau Richard, ITRI.

Dr. Han Wilu, TFDAIEK, ITRI.

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