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1 2008/06/04

2 1

3 Baby Boomer Aged Baby Boomer ~ GDP $4,000 $3,500 $3,000 $2,500 $2,000 $1,500 $1,000 $500 $ (e) 2005(f) 2006(f) 2007(f) 2008(f) 2009(f) (f) 2011(f) 2012(f) 2013(f) 2014(f) 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% 2

4 65 (CHF) (COPD) 3

5 No Data <10% 10% 14% 15% 19% 20% 24% 25% (*BMI 30, or ~ 30 lbs overweight for 5 4 woman) 4

6 100% HOME CARE Healthy, Independent Living Community Clinic Chronic Doctor s Disease Management Office RESIDENTIAL CARE Assisted Living Skilled Nursing Facility Specialty Clinic ACUTE CARE Community Hospital ICU 0% $1 $10 $100 $1,000 $10,000 5

7 6

8 7

9 From Work Productivity Need Commodity To Enjoyment Happiness Individualized 8

10 Battelle 2005 Medical treatment using highly accurate sensors 2006 Genetic-based medical treatments 2007 Home health monitors 2008 Affordable home-based health care 2020 Genetic-based medial and health care (Wellness) : Battelle Technology Forecast 9

11 / 10

12 FDA (Official National Formulary) (United States Pharmacopeia) / 11

13 EucoMed EucoMed 12

14 20,00080,000 Bjork-Shiley Dow CorningDalkon Shield 2006Boston Sci GuidantJohnson & Johnson Conor Medsystems 13

15 / IEK 14

16 15

17 Premarket Notification {510(k)}Premarket Approval Class I General Controls Class II General Controls + Special Controls CLASS III Premarket Approval 510(k) Review Investigational Device Exemption Marketing 510(k) Clearance Letter Marketing GMP Pre-approval Inspection GMP Routine Inspection PMA Approval Marketing 16

18 EU Regulations Directives Harmonized Standards (& Guidelines) Recommendations, Opinions 17

19 EU (essential health) (Essential Requirements) Requirements3rd party Active, Implants III EU MDD Conformity Assessment Procedures from 93/465/EEC Annex 2 EC Declaration of Conformity + Examination of the Product Design (Section 4) Full Quality Assurance System (Section 3) (EN 46001) Evaluation by the Notified Body Annex 2 EC Declaration of Conformity +Full Quality Assurance System (Section 3) (EN 46001) Technical Document checked during audit Evaluation by the Notified Body II b, II a, Annex 4 EC verification Statistical Verification Examination and Testing by the Notified Body Active Implants, III, II b, II a I* (Meas/Ster) Annex 3 EC-Type Examination Examination by the Notified Body Annex 4 EC verification 100% Verification Examination and Testing by the Notified Body III, II b, II a I* (Meas) Annex 5 EC Declaration of Conformity Production Quality Assurance (EN 46002) Evaluation by the Notified Body Active Implants III, II b, Active Implants III, II b, II a I* (Meas/Ster) I, I* II a I*- Sterile -Measuring Function Class I* Sterile products and measuring devices II b, II a, I* (Meas) Annex 6 ECDeclaration of Conformity Production Quality Assurance (ISO 9003) Evaluation by the Notified Body Annex 7 EC Declaration of Conformity Self Certification with Documentation available Surveillance CE 18

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24 23

25 (MDEA) MDEA) MDEA(2006)IEK 24

26 J&JAbbott BDBio- RadPromegaRoche GETycoPhilips Siemens Hitachi PanasonicIntelNTT Pride MobilityInvacareSunrise MedicalYAMAHA Suzuki 25

27 Medtronic Medtronic % 21.1% 17.8% 6.7% 8.5% 2005

28 --Intel Intel (AI ) 27

29 --A&D Medical A&D Medical 28

30 (%) (%) Ernst ; Young & Dow Jones Venture, VentureOne. 29

31 - 0.4~0.5% 20?? 30

33 /

37 IMD 36

39 38

40 39 Espicom(2007)IEK Zimmer Stryker Na Tyco International Boston Scientific Philips Siemens Fresenius Medtronic General Electric Johnson & Johnson

41 40

42 Medical Device LinkIEK(2005/09) 41

43 0.6%2015 6, IEK

44 / 1 IEK % 9.62% % (4104) -9.70% % % (4116) 12.71% (4126) 12.02% (4107) -1.30% (4117) % (4131) % (4113) 12.59% (1733) 21.42% (4129) % (1729) 14.98% (1565) 14.43% ( (11) 3.51 (4125) 2007/12/ (10) 4.29 (3373) 39.90% (4121) -4.85% (4103) 9.14% (1781) / (%)

45 % IEK(2008/05)

46 Depuy2007Zimmer Stryker % Cooper VisionOcular Science 20075(18)6 1 45

47 2007 () 2 CMS2006 2~3 46

48 / 1 IEK-ITIS(2008/05) 6.32% % (4104) -5.15% % % (4116) 15.54% (4126) 4.69% (4107) % (4117) % (4131) % (4113) -2.09% (1733) -3.57% (4129) 7.17% (1729) 29.78% (1565) 21.07% ( (4125) 8.93% (3373) 15.10% (4121) 1.59% (4103) 8.72% (1781) / (%) 2008Q1 2007Q1 %

49 ~2 1~2 % IEK (2008/05)

50 2009 BOOTS GlucoSure Voice FDA 510KK (IR- SoC)ODMBeurerLutterSamsung MastercoolCPL SPX IEK 49

51 () 54% (FDA) Invacare %200830% 6 CE () CE 14 50

52 2008 IEK -ITIS(2008/05) 51

53 ODM/OEM OTC 52

54 % 1, ITRI-IEK (2006) XMRI 53

55 -TEMPOL 1. Technology 2. Expansion 3. Motivation 4. Profit() 5. Opportunity 6. Leverage (TEMPOL) 54

56 () 55

57 _ Technology Expansion Motivation Opportunity Profit (Technology) (Expansion) 1980(Technology) 1995(Motivation) PVC(Oppurtunity) (Expansion) 56

58 _ Technology Expansion Motivation Opportunity Leverage Opportunity (Technology) 2005CooperOcular 57

59 _ Technology () Expansion Motivation Motivation Profit 58

60 59 _ HDPE HDPE

61 ( ) Baxter( ) ( ) ( ) ( ) ( ) ( ) ( IVD ) Biomet ( ) Zimmer( ) ( ) ( ) ( ) ( ) OMRON( ) ( ) ( ) ( ) ( ) -60% -40% -20% 0% 20% 40% 60% 80% 100% 60

62 1, ,000.0 A B C D E F , , , , , , , , , () 61

63 100 2,300 62

64 63

65 () 64

66 ODM/OEM 65

67 1-2 ITRIY.D.Cheng 2007) 66

68 () HEMA() LED IEK 67

69 () 68

70 69

71 70

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<4D6963726F736F667420576F7264202D2030373139C2E5C0F8BEB9A7F7B7BEB371A5ADA578B77CC4B3ACF6BFFD2E646F63> 經濟部工業局會議紀錄經濟部衛生署與業者溝通平台局處層級會議 ( II ): 醫療器材產業會議紀錄一時間 :94 年 7 月 19 日 ( 星期二 ) 上午 9 時 30 分二地點 : 經濟部工業局第一會議室三主持人 : 經濟部工業局陳局長昭義政處廖處長