UL Webinar - Updates to the Regulatory Framework in Korea and their impact to IVD and Medical Device Submissions and Important Deadlines

UL and the UL logo are trademarks of UL LLC © 2013
Updates to the Regulatory
Framework in Korea-Impact to IVD
and Medical Device Submissions
and Important Deadlines
23 July 2013
MinYong Choi
LHS Senior Technical Consultant
Life and Health Sciences BU
UL Korea, Ltd.

MinYong Choi
Background:
• ISO 13485 Auditor & CE MDD Assessor, DNV Business Assurance(2011~2012)
• Technical Reviewer, Medical Device Evaluation Department, KFDA(2005~2011)
• Bachelor’s Degree in Computer Engineering, HoSeo University
• Master's Degree in Software Engineering, HoSeo University
Additional experiences:
• Member of the ISO TC 215 (Health Informatics) Technical Committee(2007~Present)
• Wrote the KFDA Technical Guidance for Medical Device Software, 2007
2
MinYong Choi is a Senior Technical Consultant for UL
Life and Health Sciences Business Unit. He is responsible
for developing and managing the MDRS(Medical Device
Regulatory Support) business in Korea. He is an expert
for medical device software and RLR candidate for
medical device software in UL AP region.

Agenda.
Regulatory Framework of Medical Device in Korea
Recent & Upcoming Regulatory Changes
2012 Medical Device Market in Korea
Useful Links
UL One-stop Services
3

Chapter 1.
Useful Links
4

© 2013 UL LLC All rights reserved. May not be copied or distributed without permission.
Capital: Seoul
Language: Korean
Area: 100,210 ㎢
Population: approx. 50 million
Republic of Korea (South Korea)
5

Ministry of Food and Drug Safety(MFDS)
6
Headquartered in O-Song:
− Moved from Seoul to O-Song city(the Bio-
Health Techno-polis) in November 2010
− 1760 employee are working in MFDS
− It takes 30 minutes from Seoul to O-Song
by KTX
Seoul
O-Song

Organization for Medical Device in MFDS
7
7
Ministry of Food and Drug Safety
Medical Device Safety Bureau
Medical Device Policy Division
Medical Device Quality Division
Medical Device Management Division
National Institute of Food and Drug
Safety Evaluation
Medical Device Evaluation
Department
High-tech Medical Devices Division
Orthopedic and Restorative Devices
Division
Cardiovascular Devices Division
Dental and Gastroenterology Devices
Division
Regional Food and Drug Administration
Seoul Regional FDA
GyeongIn Regional FDA
Busan Regional FDA
DaeGu Regional FDA
DaeJeon Regional FDA
GwangJu Regional FDA
Medical Device Safety Management Division
Medical Products Safety Division
IVD Device and Reagent Task Force

Location of 6 Regional Offices
8
Seoul
Gwacheon
Daejeon
Daegu
Gwangju
Busan

History of Korea Medical Device Regulations
9
Pharmaceutical Affairs Act provides the definition of medical devices
Introduce a regulatory system for licensing manufacturing business and product approval
Introduce the requirements for production control and reporting
KFDA established
Introduce the classification system of medical devices based on risk level(3 classes)
Implement regulations for good manufacturing practices
Introduce two different pre-market pathways: (1) notification; and (2) approval
Eliminate local testing requirements for each and every shipments of imported medical devices
Legislate Medical Device Act
Changed to a four-class system
Begin regulating device import business, refurbishing business and rental business
Strengthen post-market surveillance system
Implement full-scale KGMP/GIP regulations
KFDA reorganized as MFDS

Structure of MFDS Medical Device Regulations
10
Medical Device Act (MDA)Act
Presidential
Decree
MFDS Ministerial
Regulations
MFDS Minister Notifications
Enforcement Regulations of MDA
Implementing Regulations of MDA
MFDS Notifications of MDA
 Notifications for detailed
requirements supporting Act and
Ministerial Regulations
MFDS Technical Guidelines & Example
Documents on Specific Requirements

MFDS Medical Device Regulations
11
Conception
Development
Manufacture
Package
Labeling
Adverting Sale Use Disposal
Manufacturer Vendor User
Pre-Market Post-Market
• Device Business License
−Manufacturing, Importing, Refurbishing,
Distributing, Rental Business
• Product Notification/Approval
−Clinical Investigation Plan Approval
• Quality System Certification
−Korea Good Manufacturing
Practice(KGMP)
• Quality System Regulation
• Labeling Requirements
• Review of Advertisement
• Medical Device Tracking
• Adverse Event & Safety Alert Reporting
• Re-evaluation
• Re-examination
• Recall
• Inspects and Audits

Product Classification
• Four classes based on potential risk to human health and purpose of use
• Harmonized with GHTF rules
12
Class Risk Device Examples
I Little
Trial Lens Set, Skin Staple, Surgical Light, Electrically-
powered Table
II Low Umbilical cord clip, Infusion pump, PACS
III Moderate Silk Suture, Contact lens
IV High Coronary stent

IVD Reagents Classification
13
Class Risk Device Examples
I
Low or No personal/public
health risk
Culture medium, Tissue and cell dye or stain, support
gel, agar
II
Moderate individual
and/or low public health
risk
Helicobacter phylori( H. pylori), Proteins, Bilirubin,
Creatinine(Cr)
III
High individual and/or
moderate public health
risk
Toxoplasma, Cytomegalovirus(CMV)
IV
High individual risk and
high public health risk
Human immunodeficiency Virus(HIV), Human helatitis
C Virus(HCV)

Medical Device Registration Process Overview
14
Apply & Approve (Within 10 Days)
Class 1
Announced
(From MFDS)
Equivalent
Product
MFDS
Regional
Office
Equivalent
Product
&
Improved
Product
New
Product
MFDS
Head
Quarter
Technical
Review
Technical
Review
(Include Clinical
Investigation)
Class 2
Third-party Review
Organization
Class 3
Class 4
Web Registration System http://emed.mfds.go.kr
Apply
Apply & Approved (Within 65 Days)
Issue Notice

Criteria for Determining the Device Type for
Class 2
15
No
Yes
Equivalent
with
Performance
or Test
Standards or
IFU?
Is it Non-
active
Device?
Yes
Yes
No
Equivalent
with Intended
use and
Principle?
Improved
Product
Compare
with
Approved
Device
Equivalent
with Low
materials?
No
Equivalent
Product
No
Yes
New
Product
①
②
③
④
⑤

Documentation Requirements by Device Type
for Class 2
16
Apply for Registration
1.Comparing Chart for Equivalent
2.Performance Data(included in the
Test Reports)
3. Test Reports
4. Background of Development
5. Clinical Evaluation
5. Post-market information
Equivalent Product Type Improved Product Type New Product Type
Applicant
1.Comparing Chart for Equivalent
2.Test Reports

Required Data
Process
1 2 3
Required Test Records
5 6 7
4-a 4-b 4-c 4-d 4-e 4-f 4-g
Equiv
alent
Chart
Intend
ed
Use
Princi
ple of
Opera
tion
Electri
cal
Radiat
ion
EMC
Bioco
mpatib
ility
Perfor
mance
Mecha
nical
Chemi
cal
Stabilit
y
Clinica
l
Evalu
ation
Backg
round
of
Devel
opme
nt
Post-
Marke
t
Inform
ation
New
Different Intended
Use
○ ○ X ○ △ ○ X ○ X X ○ ○ ○
Different Principle of
Operation
○ X ○ ○ △ ○ X ○ X X ○ ○ ○
Different Low
Material
○ X X X X X X X X X X X X
Improve
Different
Performance
○ X X X X X X ○ X X X X X
Different Test
Standards
○ X X ○ △ ○ X X X X X X X
Different Instruction
for Use
○ X X X X X X X X X △ ○ ○
Equivalent ○ X X X X X X X X X X X X

Technical Documentation
18
No Medical Devices IVD Reagents
1 Product name, classification, model name
2 Shape, structure, dimension, color Color, properties, material property
3 Raw material, component, amounts, composition
4 Manufacturing process
5 Intended use Intended use(Analysis device, specimen, principle
of measurement, quantitative/qualitative method)
6 Performance Performance(Sensitivity, Specificity, Precision,
Accuracy, Cross-reactivity, and etc.)
7 Operating procedure & method, precautions, packing units
8 Storage conditions and stability duration
9 Test standard
10 Labeling

Comparing Chart Form
19
No Items Approved Product Applied Product Equivalent
1 Classification
2 Product Name(Model)
3
Manufacturer
(Distributor) Name
4
Manufacturer &
Location
5 Registration No.
6 Intended Use.
Yes □
No □
7 Principle of Operation
Yes □
No □
8
Low Material or
Critical Component
Yes □
No □
9 Performance
Yes □
No □
10 Test Standards
Yes □
No □
11 Instruction for Use
Yes □
No □
Date (Sign)

Test Reports Acceptance
20
a. Medical Instruments or dental Materials.
• Test Report from test laboratories accredited by MFDS(before KFDA) is acceptable same
as electrical safety.
• GLP test data issued by an authorized GLP laboratory under GLP of the Organization(in
case of biological safety)
b. Electrically or mechanically-driven devices.
• CB Test Report and KORAS Test Report(in case of electrical safety)
c. Performance Test Report(Common)
• Test Report written by manufacturer can be acceptable under quality management system.

KGMP Certified Company Status
KGMP is mandatory requirement since 2007.05.30 in Korea
KGMP Regulatory Requirements are based on ISO 13485
21
11
157
440
1,312
1,460
1,637
1,838
1,983
10 124 312
1,159
1,261
1,385 1,453 1,568
21
281
752
2,471
2,721
3,022
3,291
3,551
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
2004년 2005년 2006년 2007년 2008년 2009년 2010년 2011년
제조 수입 합계
Manufacturer Importer Total

Regulatory Changes in KGMP
22
Until April 7, 2012
KGMP is Mandatory to All
Class 1 Devices
KGIP is Mandatory to
Abroad Manufacturing Site
(For Importing Company)
39 Product Categories
for KGMP
Apply the Complimentary
Audit for Non-conformance
Result
Since April 8, 2012
KGMP is excepted for
Class 1 Devices
(Except 66 Product Items)
KGMP is Mandatory to
Abroad Manufacturing Site
(For Importing Company)
25 Product Categories
for KGMP
Summit the Corrective
Action Records for Non-
conformance Result

KGMP Audit Types
23
• New & the first case
• Construction of KGMP System
Initial Audit
• Add New Product Category
• Construction of KGMP System for New Product Category
Additional
Audit
• Manufacturing Site Transfer
• Construction and Changing of KGMP System for
Manufacturing Site Transfer
Changing
Audit
• Every 3 Year / At least 1 time
• Until 90 days before expire date
Regular Audit

Who are the KGMP Auditors?
24
KGMP
Inspection
Institute
MFDS
Headquarter
MFDS 6
Regional
Officer

Medical Device License Validity
25
License When you apply Current Designations Validity
Product License:
Manufacturing Approval or
Import Approval
For each product
code
2,059
classifications
Permanent
Quality System Certification:
KGMP Certification for
Manufacturer
For each
of 25 device
categories
25 categories 3 years
Device Business License For each
of the five
business types
5 Business Types Permanent

Chapter 2.
Useful Links
26

Introduction of the Summary Technical
Documentation(STED)
27
January first 2014
Class 4
Except IVD Reagent

Introduction of the Summary Technical
Documentation(STED)
The regulation for STED has been revised on May 8, 2013
Benefit on STED: Fast Track Technical Review by MFDS
Technical Guidance for STED will be published by MFDS until Sep.
2013
28

Introduction of IEC 60601-1(third edition) with
amendments
Transition Data:
• June 01, 2014: Class 3 & 4
• June 01, 2015: Class 2
• June 01, 2016: Class 1
29

Revised "Regulations on Classification and
Grades"
• 94 new products are added under "cell manipulating kit for medical
use".
• Definitions of 108 products including “heater system” have been
changed.
• The Class of “a dental color measuring device” was down-classified
into Class 1 from Class 2.
• 67 commercial names including “warm bath equipment” are edited
out.
• These changes are effective as of the date of notification.
30

Revising the Medical Device Software
Guidance
IEC 60601-1, Clause 14 & IEC 62304 Requirements
ISO 14971 Risk Management
IT-Network, Mobile Wireless, Medical Informatics, U-Healthcare
STED
31

Identifying Product Items required Clinical
Investigation Data
MFDS will notice the product items which shall be required the clinical
investigation data.
This regulation is similar with US PMA products identification.
It’s just researching stage by MFDS.
32

Chapter 3.
Useful Links
33

Number of Medical Device Business Entities
Business Entity Year
2008 2009 2010 2011 2012
Manufacturer 1964 2031 2168 2245 2550
Importer 1571 1609 1626 1662 1898
Total 3535 3640 3794 3907 4448
34

Number of Product Approval & Notification
Registration Type Year
2008 2009 2010 2011 2012
Notification 3437 3631 4341 3585 3959
Approval 2224 2429 2666 2899 4013
Total 5661 6060 7007 6484 7972
35

2012 Medical Device Market Overview in Korea
36
1,132 1,190
1,454
1,673
1,967
2,123
1,879
2,266
2,521 2,601
-991
-689
-811 -848
-634
9.7
5.1
22.2
15
3.17
-1.4
-11.5
20.6
11.3
17.55
-15
-10
-5
0
5
10
15
20
25
30
-1500
-1000
-500
0
500
1000
1500
2000
2500
3000
2008 2009 2010 2011 2012
Export(million$) Import(million$) Trade balance(A-B)
Rate of export(%) Rate of import(%)

Exporting Product Items (From Korea to Abroad)
37
23.13%
5.21%
4.91%
4.83%
4.36%
(Unit : 1,000 $)
Ranking Product Item Amount %
1 Ultrasound imaging system 454,824 23.13
2 Soft contact lens 102,433 5.21
3 Dental implant 96,573 4.91
4 Sight corrective ophthalmiclens 94,917 4.83
5 IVD strip for high throughput 85,684 4.36
6 Heating pad system 81,087 4.12
7 Probe for medical use 74,715 3.80
8 PACS/Software 57,394 2.92
9 Digital diagnostic X-ray system 53,618 2.73
10 Combinational stimulator for medical use 51,556 2.62

Importing Product Items (From Abroad to Korea)
38
3.98%
3.84%
3.55%
2.70%
2.44%
(Unit : 1,000 $)
Ranking Product Item Amount %
1 Stent 103,453 3.98
2 Soft contact lens 99,977 3.84
3 MRI 92,356 3.55
4 CT system 70,329 2.70
5 Knee prosthesis 62,365 2.40
6 Dialyser 60,941 2.34
7 Sight corrective ophthalmiclens 60,268 2.32
8 Probe for medical use 53,581 2.06
9 Intravascular catheter 49,440 1.90
10 Ultrasound imaging system 43,059 1.66

Exporting Company (From Korea to Abroad)
10.71%
9.64%
3.65%
3.15%
2.56%
Ranking Exporting Company Amount %
1 Samsung Medison Co., Ltd. http://www.samsungmedison.co.kr 210,715 10.71
2 GE Healthcare Ultrasound Korea http://www.gehealthcare.com/krko/uskorea/index.html 189,639 9.64
3 Nuga Medical Co., Ltd. http://www.nugamedical.com 71,732 3.65
4 Siemens Ultrasound Korea PoHang Office http://www.siemens.co.kr/healthcare 62,039 3.15
5 Vatech http://www.vatech.co.kr 50,331 2.56
6 Siemens Ultrasound Korea http://www.siemens.co.kr/healthcare 47,318 2.41
7 Ceragem Co., Ltd. http://www.ceragem.co.kr 46,766 2.38
8 i-Sens, Inc. Wonju Office http://www.i-sens.co.kr 44,087 2.24
9 Daemyung Optical http://www.dmo.co.kr 38,890 1.98
10 Osstem Implant http://en.osstem.com 34,499 1.75
(Unit : 1,000 $)
39

Importing Company (From Abroad to Korea)
6.24%
4.81%
3.57%
3.10%
3.07%
(Unit : 1,000 $)
Ranking Importing Company Amount %
1 Siemens Ltd. http://www.siemens.com/answers/kr/ko/ 162,181 6.24
2 Johnson & Johnson Medical Korea http://www.jnjmed.co.kr 125,053 4.81
3 Medtronic, Inc. http://www.medtronic.co.kr 92,735 3.57
4 GE Healthcare Korea http://www3.gehealthcare.co.kr/ko-KR 80,605 3.10
5 Johnson & Johnson Korea Ltd. http://www.jnj-korea.co.kr 79,725 3.07
6 Covidien Korea http://www.covidien.com/kr/pages.aspx 74,361 2.86
7 Philips http://www.philips.co.kr 63,629 2.45
8 Stryker Korea http://www.stryker.com/kr/index.htm 61,196 2.35
9 Abbott Korea http://www.abbott.co.kr 56,825 2.18
10 Roche http://www.roche-diagnostics.co.kr/Pages/default.aspx 52,678 2.03
40

Exporting Country (From Korea to Abroad)
United States
$ 346,673
17.63%
Germany
$ 208,467
10.60%
China
$ 183,131
9.31%
Japan
$ 346,673
17.63%
$ 175.088
8.90%
Russia
$ 346,673
17.63%
$ 159,600
8.12%
Unit : 1000$
41

Importing Country (From Abroad to Korea)
United States
$ 1,171,751
45.05%
Germany
$ 378,123
14.54%
Japan
$ 336,597
12.94%
China
$ 346,673
17.63%
$ 130,248
5.01%
Unit : 1000$
Swiss
$ 346,673
17.63%
$ 115,178
4.43%
42

Chapter 4
Useful Links
43

Useful Links
Ministry of Food and Drug Safety, http://www.mfds.go.kr/eng/index.do
Medical Device Safety Bureau in MFDS,
http://www.mfds.go.kr/medicaldevice/index.do
MFDS Official News for Medical Device,
http://www.mfds.go.kr/medicaldevice/index.do?nMenuCode=92
MFDS Technical Documents Sample for Medical Device,
MFDS Technical Guidance for Medical Device,
MFDS KGMP Certified Company,
MFDS e-Submission System, http://emed.mfds.go.kr
44

Useful Links
MFDS On-line Searching System(Company, Product, Intended use,
Licensed No., etc.), http://emed.mfds.go.kr/kfda2
Medical Device Information & Technology Assistance Center,
http://www.mditac.or.kr
Korea Medical Devices Industrial Cooperative Association,
http://www.medinet.or.kr
Korea Medical Devices Industry Association, http://www.kmdia.or.kr
45

Chapter 5.
Useful Links
46

UL One-stop Services: Overview
47
On-Line Training Service by UL Quality, Compliance and Learning
ISO 13485 / ISO 9001 Quality Management Systems & FDA QSR & MFDS KGMP
ISO 14971 Risk Management
Early Engagement
IEC 60601-1
Electrical Safety / EMC
IEC 60601-1
Notified Body / Certification
Usability Engineering & Testing IEC 62366 / IEC 60601-1-6
IEC 62304 Software Validation
Basic
Research
Define
Requirements
New
Product
Idea
R & D Prototype
Preclinical
Bio-comp
Clinical
Trials
Final
Device
Regulatory
Submission
Commercial
Launch
Advisory Services for Global Regulatory Requirements: Technical Documentation & Submission (FDA, CE MDD, MFDS, CFDA, TFDA, etc.)
Biocompatibility Testing (ISO 10993)
Mechanical & Functional Testing
Manufacturing Process Validation(e.g. Cleaning)
Microbiology and Sterilization Validation
Package Validation, Shelf Life & Transport Validation (ISO 11607-1, -2)
Reprocessing Validation (ISO 17664)

UL One-stop Services: Advisory Services for
MFDS(Regulatory Requirements in Korea)
Business
Growth with
UL
Korea Market
Research
Product
Registration
KGMP
Compliance
License
Management
by UL Sub-
contractor
48

THANK YOU.
Contact Information:
Medical.Inquiry@ul.com
MinYong Choi (Seoul, Korea)
+82.2.2009.9366
MinYong.Choi@ul.com

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