2014 3 4

Copyright 2014 ITRI

Copyright 2014 ITRI

FY101FY101-104

1.
1.


2.
2.
3.
3.

1.
1.
2.

2.
3.
3.
4.
4.

()
)

1.
1.
2.

2.


A.

+
+

B.

ICT
ICT

+
+

TRL 1~TRL 2

/
/
1

Copyright 2014 ITRI

TRL9

TRL 3~TRL 8

/
/(
()
)
5

ITRI Regulatory Based Medical Device

Technology Readiness Level (TRL)

TRL

Copyright 2014 ITRI

GMP/ISO 13485

N.A.

N.A

Device conception

N.A.

Regulatory Pathway

4
5

test /

(
)

test

Regulatory
Readiness

6
7
8
9

Regulatory pathway

Intended use
Requirements for safety and
effectiveness
SE/ER Assessment

Device specifications and
preliminary assessment
Risk Assessment

HF/UE testing
Preclinical Evaluation
Risk management
HF/UE Testing
Clinical investigation and
evaluation
QMS/
TCF/DMR
Product approval
Post-market surveillance

TCF/DMR

SE/EP
/
TCF/DMR
(STED/510(k)/PMA)
GMP

Regulatory Pathway and Evaluation

Copyright 2014 ITRI

Audits - Internal and External Certification

Coverage of the complete quality management system

STED

Technical Information

QMS and Risk Management

are applicable throughout the complete product life cycle (including managing changes)

Phase I:
/
()

Phase II:

()

FY103
FY103

(intended use)

(indications for
use)

Re-define the Device

Intended Use or
Instruction for Use

FMEA, FTA

Essential Principles
Assessment
Substantial
Equivalence Comparison
with Predicate and/or
Reference Devices
Design Input
Verification
and Validation Protocols
Regulatory
Pathway Identification

Design History
File
Copyright 2014 ITRI

Predicate Devices or
Reference Devices

Competent Authority
Recognized Standards
and Guidance

Usability Study and Risk

Analysis

Consensus Standards

Design and
Development Control

FY103
FY103

:
:
Pilot
Production
Devices

Review
Risk analysis Report

Re-design or
Modify the Device

Review Essential
Principles Assessment
Report

Competent Authority
Recognized Standards
and Guidance

Review Substantial
Equivalence Comparison
Report

Usability Study and Risk

Analysis

Verification
Testing (Pre-clinical)
Report

Consensus Standards
and Protocols

Validation
Testing and Clinical
Evaluation Report

Healthcare
Technology Assessment

Regulatory Filing
or Commercialization

Design History
File
Copyright 2014 ITRI

Predicate Devices or
Reference Devices

FY103
FY103
:
:

1. 1.

2.
3.

4.
5.

2.
1.

2.
3.

Copyright 2014 ITRI

1.
2.

3.

4.
5.

1.

2. SOP
3.

FY102
4. D- (Class II)

TFDA GMP
CFDA

1. A- X Generator (Class II)

2. B - (Class II)

3. C - (Class II)

TFDA GMP ISO13485

Copyright 2014 ITRI

5. E-
(Class TBD)

6. F - (Class II)

/


CFDA
510(k)

FY103
FY103

Copyright 2014 ITRI

Copyright 2014 ITRI

(101~104)
2

FY103

103.03.04

103.03.04~04.21

103.04.02~04.25

103.04.30

Copyright 2014 ITRI

60

(40%)

(30%)

(15%)
(15%)
/

Copyright 2014 ITRI

/
/

/
/

Food and Drug

Administration

BSI, SGS
MDC

Global
Harmonization
Task Force
Asian
Harmonization
Working Party
ISO / IEC
Copyright 2014 ITRI

()

(1027)
Premarket Notification [510(k)] Third Party Review (FDA
Modernization Act of 1997 and Medical Device User Fee
Amendments of 2007 )
Quality System /Good Manufacturing Practice Third Party
Inspection (MDUFMA 2002)
(MDD 93/42/EEC)
(IVDD 98/79/EC)ISO 13485:2003

Member of SG4: Regulatory Auditing

Member of SG1 IVD Subgroup
Speaker of 5TH Asia-Pacific Economic
Cooperation (APEC)-Funded Seminar on
Harmonization of Medical Device
Regulations
Technical Committee WG01, WG03
WG04
ISO TC 210, IEC - TC 62A/SC observer

1700

495

13
195
FDA GMP

Pan
America Health Organization, World Health Organization
Asian Harmonization Working Party

(ASEAN)27

ISO 13485, IEC 62366 -1/ -2

18

National Competent Authorities

GHTFAHWPISO TC 210, IEC 62A

BSI, SGS, MDC, Presafe DenmarkA/S

19
Copyright 2014 ITRI

20

Copyright 2014 ITRI

10

Tel: 03-5743836
cchan@itri.org.tw

Tel: 03-5732294 Tel: 03-5732043

sliao@itri.org.tw jywu6@itri.org.tw

Tel03-5743771
Fax03-5734092
cs1108@itri.org.tw

http://medical.cms.itri.org.tw/

Copyright 2014 ITRI

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