1. Latest Updates on
Medical Device Regulations in Korea
November 2013
Young Kim
Synex Consulting Ltd.
Seoul, Korea

2. About Synex
Descriptions
Features
Business
Consulting company
specialized in healthcare
market access
Established
April 2002
Employees
60 full-time employees
Expertise
Market Entry Issues
Customer
Industry
Medical device
In-vitro diagnostics
Pharmaceutical
Biologics
Service
Sectors
Regulatory
Device Qualify System
Reimbursement
Clinical Research (CRO)
Market Research
Distribution Set-up
Marketing Compliance
November 2013
© Synex Consulting, Ltd.
2

3. Topics
• Korea as a medical device market
• Medical device approval process
November 2013
© Synex Consulting, Ltd.

4. Korea
as a Medical Device Market

5. Geography, Population and Economy
 Population (2012, Korea Statistics Office)
- 50 million
- 26th Largest population in the world
largest country in the world)
- cf. The Netherlands 16.7 million
- Average life expectancy at birth: 79.1
-Median age: 38
–Increasing Elderly Population
•+65 population: 5.4 million (11.3%
of total population)
Land Space
-98,480km2 (South Korea)
- cf. The Netherlands 41,526㎢
November 2013
 Economy (2012, IMF Estimates)
-GDP per capita: US$23,679
-34th in the world ranking
-
cf. The Netherlands $41,447
© Synex Consulting, Ltd.
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6. Market Size
US$ millions
% Changes
from 2011
4,290
Up 6.23%
Local Production
3,656
Up 15.18%
Export
1,966
Up 17.56%
Import
2,600
Up 3.17%
Year 2012
Total Market
Device Trade Deficits
634
Rank
s
KOREA
Countries
39.1%
Japan
31,496
10.2%
3
Germany
23,256
7.6%
4
China
13,956
4.5%
The 3rd largest market in Asia following
5
France
13,315
4.3%
6
UK
8,934
2.9%
China
7
Italy
8,417
2.7%
8
Canada
6,372
2.1%
9
Russia
5,456
1.8%
10 Spain
4,695
1.5%
11 Australia
4,443
1.4%
12 Brazil
•
4,417
1.4%
13
© Synex Consulting, Ltd. Korea
4,075
1.3%
The
•
•
•
largest market in the World in 2012
World medical device market in 2012: US$307,735 million
1.3% of the world device market
November 2013
USA
2
World
Market Share
120,397
13th
1
US$ Million
6

7. Supply Portfolio: Import vs. Domestic Products
•
Imports
• Supply around 60% of supply of medical devices
• Expensive, high-tech devices are mostly supplied by the U.S.,
EU and Japan.
• Inexpensive, low-tech devices (Class 1, II devices) are
increasingly supplied by imports from, e.g., China
•
Local manufacturers
• Supply mid-tech devices, mostly Class II devices
• Rapidly improving quality of products and expanding their export
markets.
• Korean government is continuously increasing its public R&D
grants to support local development of medical devices. Local
manufacturers are expected to expand their positions in the
market in a longer term.
November 2013
© Synex Consulting, Ltd.
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8. Device Suppliers
• 3,528 device business firms (2011)
•
•
1,958 manufacturers
1,570 importers
• 6,000-7,000 new products approved every year.
5,000
4,500
4,000
3,500
3,000
2,500
2,000
1,500
1,000
500
0
2006
2007
2008
2009
2010
2011
2012
Notification
3,131
3,604
3,437
3,631
4,341
3,585
3,881
Approval for manufacture
1,008
731
950
1,067
1,312
1,413
1,604
Approval for import
1,355
1,167
1,274
1,362
1,354
1,486
1,496
November 2013
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9. Geographical Distribution of Business
•
The five largest cities represent
about 60% of total hospital beds in
the country
•
•
•
•
•
•
Seoul and Kyonggi ( around 38%)
Pusan (around 9%)
Daegu (around. 5%)
Kwangju (around 4%)
Daijeon (around 4%)
The Seoul and Kyonggi areas
(called ‘Seoul Metropolitan Area)
represent about 60% of the
imported high technology medical
device market.
November 2013
9
© Synex Consulting, Ltd.
Copyright © Synex 2009, All Rights Reserved
9

10. Healthcare Resources (2011)
• Healthcare Organizations
– University hospitals (tertiary centers): 44
– Medium-size general hospitals: 275
– Small-size hospitals: 2,403 (1,005:Geriatric hospital)
– Clinics: 27,996
– Dental hospitals & offices : 15,409
– Oriental hospitals: 12,686
• All healthcare organizations are reimbursed
by public health insurance in Korea
November 2013
© Synex Consulting, Ltd.
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11. Supply Portfolio: Import vs. Domestic Products
•
Imports
• Supply around 60% of supply of medical devices
• Expensive, high-tech devices are mostly supplied by the U.S.,
EU and Japan.
• Inexpensive, low-tech devices (Class 1, II devices) are
increasingly supplied by imports from, e.g., China
•
Local manufacturers
• Supply mid-tech devices, mostly Class II devices
• Rapidly improving quality of products and expanding their export
markets.
• Korean government is continuously increasing its public R&D
grants to support local development of medical devices. Local
manufacturers are expected to expand their positions in the
market in a longer term.
November 2013
© Synex Consulting, Ltd.
11

12. End-User Characteristics
•
The five super-size hospitals targeted for door-opening centers
for new health technologies
•
•
•
•
•
•
Asan Medical Center (AMC) – 2,600 beds
Samsung Medical Center (CMC) – 2,000 beds
Seoul National University Hospital (SNUH) – 1,600 beds
Yonsei Medical Center (YMC) – 1,880 beds
Catholic St. Mary’s Hospital (CMC) – 1,200 beds
Doctors
• Highly receptive to new technologies
• Doctors at teaching hospitals are mostly trained in the U.S. and they attend
almost all international academic conferences
• Most influential on purchasing decisions
•
Patients
• Highly receptive to new technologies
• Look for hospitals offering latest therapies with advanced equipment
November 2013
© Synex Consulting, Ltd.
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13. Public Health Insurance System
•
National Health Insurance (NHI)
– The sole national insurer in Korea
– Ministry of Health and Welfare (MOHW) operates the NHI system
– All income-earning citizens must contribute a certain percentage of income
every month.
– 5.89% for corporate employees for 2013
– All hospitals and clinics must be reimbursed by the NHI reimbursement plan.
– Free access to healthcare organizations with no geographic limits
– Patients co-pay 20-50% of the published amount of fees for covered services
or products
• Patients pay full costs for uncovered services or products
•
Elderly long-term insurance created to support senior citizens
November 2013
© Synex Consulting, Ltd.
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14. Steps to Korean Market
Select a distributor
or third-party license
holder
Regulatory
Approval
•
A Korean legal entity is needed

•
All devices are required for pre-market
listing or approvals

Reimbursement or
non-reimbursement
Approval
•
November 2013
No medical devices exempted from pre-market
processes
Disposables or implanted devices are
mostly reimbursed by government

Launching
A license-holder must be a Korean company to
which MFDS grants an import approval.
Devices unreimbursed by government still
must submit an application to government to
get an official announcement as a
unreimbursed item and thus a full patient
charge
© Synex Consulting, Ltd.
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15. Medical Device Approval Process

16. Ministry of Food and Drug Safety (MFDS)
Seoul
•
•
MFDS makes policies
Its sub-agency called National Institute
of Food & Drug Safety Evaluation
(NIFDS) provides technical reviews on
individual applications
• Headquartered in O-Song, Chungbuk
- 120 km South of Seoul, capital city of Korea
November 2013
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17. Responsible Offices
Ministry of Food &
Drug Safety (MFDS)
National Institute of
Food & Drug Safety Evaluation
(NIFDS)
Medical Device Safety Bureau
Medical Device Evaluation Dept.
Medical Device Policy
Division
Medical Device
Management Division
Medical Device Quality
Division
Cardiovascular Device
Division
Orthopedic & Rehabilitation
Device Division
In-Vitro
Diagnostics
Task Force
Oral & Digestive Device
Division
High-Tech Device Division
November 2013
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18. Device Classifications

Class


4 Classes based on level of risk
Classification

2,202 Classification including 64 IVD and 16 u-healthcare
device

A full list of product groups and classes are available publicly.
Upcoming Change in 2014!
-IVD has been regulation as medical device since 2011 July
- Some manual IVDs regulated as pharmaceutical products currently
(e,g. Pregnancy test kit),
- All IVDs will be regulated as medical device in 2014 except DNA chip and IVD with
radiopharmaceuticals
November 2013
© Synex Consulting, Ltd.
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19. Pre-market Approval Pathways
• Regulatory pathways determined by class and similarity to
previously approved devices
Class I
MFDS
Review times
(Total timeframe
recommended for company)
E-listing to MFDS
Database
No review
(1-2 months)
Designated
equivalent product
Class II
Equivalent Product
10 days
(2-3 months)
Technical document
review by third party
review body
10 days
(3-5 months)
25 days
Novel Product
Class
III & IV
November 2013
80 days
(7-9 months)
Technical
Document Review
65 days
(5-7 months)
Technical &
Clinical Document
Review © Synex Consulting, Ltd.
80 days
(7-9 months)
19

20. Pre-Market Processes for Class II, III, IV
Importer in Korea
Technical Documents
Review by MFDS
Certificate of product
approval by MFDS
In case the
importer
or
the manufacturing
site is not KGMPcertified,
Ready to Import
KGMP Certification to
Manufacturing Site by
MFDS
Ready to Sell
November 2013
In case importer
and manufacturing
site already
KGMP-certified,
© Synex Consulting, Ltd.
Upcoming Change in 2014!
KGMP certification must be
completed before product
approval.
20

21. Information required for Technical Document
No.
Information or test reports
0
Comparison chart to determine substantial equivalency
1
Purpose of use/Product specification /Picture /Drawing
2
Physicochemical properties with test report
3
Electromechanical safety test report
4
Biological safety test report
5
Radiation safety test report
6
Electromagnetic interference test report
7
Performance test report
8
Stability test report
9
Discovery or development processes
10
Clinical study reports
11
Information on uses in other countries, etc.
Information requested varies depending on class, regulatory pathway
and product characteristics
November 2013
© Synex Consulting, Ltd.
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22. Work Scopes of Third Party Organizations
Organization
Technical
documents
review for class
II devices
KGMP
certification
Local testing
Korean Testing Laboratory (KTL)
O
O
O
TUV SUD
O
X
X
Korea Testing Certification (KTC)
O
O
O
Korea Conformity Laboratories
(KCL)
O
O
O
Korea Testing & Research
Institute (KTR)
O
O
O
SGS Korea
O
X
X
November 2013
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23. Acceptability of Foreign Test Reports
•
Tests should be selected and conducted against MFDS standards
or recognized international standard, such as ISO
•
Test report qualification for biological test
– GLP Test report by GLP certified lab
– ISO 10993
•
Test report qualification for Electrical Safety or EMC test
- CB Test report by CB certified lab
- Upcoming change in 2014!
- Requirements for the third edition of IEC 60601-1 to be introduced
•
Test report qualification for performance and stability
- ISO 13485-certified manufacturers’ labs
November 2013
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24. Clinical Reports
•
No local clinical study is necessary, if foreign clinical reports are
convincing for approval
•
•
MFDS has the right to ask for a local clinical study
Four criteria for accepting clinical reports
•
Clinical studies conducted in Korea
– Studies conducted by Korean hospitals designated by MFDS
•
Foreign studies
– Reports published in medical journals
– MFDS determines whether studies were conducted according Korean GCP
standards
– Clinical information reviewed and approved by OECD country authorities
•
Proposed Changes
•
•
November 2013
MFDA plans to require clinical reports on 68 product groups of class IV
devices in 2014.
Foreign clinical reports are acceptable, but a study should have been
conducted with the exact device applied for approval
© Synex Consulting, Ltd.
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25. KGMP Certification to Foreign Manufacturer
• A new process introduced on April 2012
• Importer (license-holder) applies to MFDS for KGMP
certification
• MFDS reviews quality system of foreign manufacturer
through documents review or site audit
• Certified separately to 26 categories
• KGMP certificate is provided to importer
• Importer’s role is limited as applicant for KGMP audit
on foreign manufacturer and quality control after
importation
• Must be renewed every three years
November 2013
© Synex Consulting, Ltd.
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26. Pathways for KGMP certification
Adding new product
groups to an already
certified
manufacturing site or
a manufacturing site
change
Class
Manufacturing
site new to Korea
Class 1
Document Review
Document Review
Class 2
Site Audit by Third
Party Inspector
Document Review
Class 3
Class 4
November 2013
Renewal
of KGMP certificate
Document Review
Site Audit by Third Party
Inspector
Site Audit by Third
Party Inspector and
MFDS
Site Audit by Third Party
Inspector and MFDS
© Synex Consulting, Ltd.
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27. KGMP to Foreign Manufacturer Site inspection
• Length of Inspection Days: 3-5 days
• Number of GMP Inspectors: 2-3
– Third-party inspectors : 1
– MFDS inspectors : 1~2
• Language at on-site inspection: Korean
– Interpreter should be arranged.
– Language problems may significantly influence the results.
• Cost
– Application Fee : 1,400-1,700(US$)
– Travel costs (for site inspection): 5,000~7,000(US$) per
inspector including air fares, accommodation, per diem
November 2013
© Synex Consulting, Ltd.
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28. Document requested for KGMP Certification
 Overview of manufacturer
 Number of quality-related staff members
 List of medical devices manufactured by the manufacturer
 Copies of certificates from other quality systems
 Summary of manufacturing facilities
 Information on outside vendors
 Inspection records from other competent authorities
 Copies of quality manuals (including quality policies)
 Device master file for the respective product (including processes for sterilization,
software validation, etc.)
 Relevant manuals for products requiring installation or after-sales support
 Device master file of a representative product (for periodical re-certification only)
 Checklist prepared by importer(upon periodical re-certification only)
November 2013
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29. Post-Market Programs
• Five PMS Programs
• Tracking
• Re-evaluation through PMS study
• Adverse event / safety alert reporting
• Recall
• Re-examination
November 2013
© Synex Consulting, Ltd.
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30. Upcoming Changes in 2014
• IVD
– All IVDs will be regulated as medical device in 2014 except DNA chip and IVD with
radiopharmaceuticals
•
KGMP certification must be completed before product approval
KGMP Certification
Application
Product Approval
Application
Product Approval
2014
Product Approval
Application
KGMP Certification
Application
KGMP Certification to
Manufacturing
November 2013
KGMP Certification to
Manufacturing Site
Product Approval
© Synex Consulting, Ltd.
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31. Upcoming Changes in 2014
•
STED for Class IV devices
– Submission of STED (Summary Technical Document) is required
for Class IV approval beginning January 2014
•
IEC 60601-1 3rd edition to be implemented
•
Clinical reports are required for 68 device groups
– Clinical report is accepted only in case clinical investigation is
conducted with the exact device
•
Unique Device Identification (UDI) should be implemented on all
tracked devices
•
Hospitals required to notify recalls to patients
November 2013
© Synex Consulting, Ltd.
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32. Thank you!
For further information, please contact:
www.synex.co.kr
webmaster@synex.co.kr
10th Floor Daejong Building
143-48, Samsung-dong, Gangnam-gu
Seoul 135-601, Korea
Phone 82-2-6202-3300
Fax 82-2-2040-6250