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111
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
2
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$)
63 73 93
# Companies 405 370 580(85% GMP)
# Staffs 10,250 18,500 25,800
Import:Export 58:42 79:21 57:43
Annual Growth 9% 2% 7%
資料來源:DCB,IEK,經濟部生技醫藥產業發展推動小組,2011年。
4
5
Product Company 2011 Revenue
Blood PressureMeter
百略Microlife
4.3 (B NT$)
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
5
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%)
8
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
11
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
12
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
121212
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.
141414
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
1515
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
17
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
18
Domestic class III device product licensesfrom 24 to 32, a 33% gain.
18
19
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
20
IEK estimates: shortening the registration by 30 days may increase 7 billion NT$ of domestic output value for medical device industry
21
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.
21
22
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)
22
23
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)
23
Acknowledgements:
Dr. Lin CS, Lin Associates.Dr. Shau Richard, ITRI.
Dr. Han Wilu, TFDAIEK, ITRI.
24