Latest update Korean Regulations By Y. Kim - Synex (Qserve conference 2013)

Latest Updates on

Medical Device Regulations in Korea

November 2013

Synex Consulting Ltd.

Seoul, Korea

Young Kim

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

2 © Synex Consulting, Ltd. November 2013

• Korea as a medical device market

• Medical device approval process

Topics

© Synex Consulting, Ltd. November 2013

Korea

as a Medical Device Market

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㎢

Economy (2012, IMF Estimates)

-GDP per capita: US$23,679

-34th in the world ranking - cf. The Netherlands $41,447


Market Size

KOREA

• The 13th largest market in the World in 2012

• World medical device market in 2012: US$307,735 million

• The 3rd largest market in Asia following

China

• 1.3% of the world device market

Year 2012 US$ millions % Changes

from 2011

Total Market 4,290 Up 6.23%

Local Production 3,656 Up 15.18%

Export 1,966 Up 17.56%

Import 2,600 Up 3.17%

Device Trade Deficits 634

Ranks

Countries US$ Million World

Market Share

1 USA 120,397 39.1%

2 Japan 31,496 10.2%

3 Germany 23,256 7.6%

4 China 13,956 4.5%

5 France 13,315 4.3%

6 UK 8,934 2.9%

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 Korea 4,075 1.3% 6 © Synex Consulting, Ltd. November 2013

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.


• 3,528 device business firms (2011) • 1,958 manufacturers • 1,570 importers

• 6,000-7,000 new products approved every year.

Device Suppliers

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

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000


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.

Copyright © Synex 2009, All Rights Reserved 9 9 © Synex Consulting, Ltd. November 2013

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


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.


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


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


Steps to Korean Market

Select a distributor

or third-party license

holder

Regulatory

Approval

Reimbursement or

non-reimbursement

Approval

Launching

• A Korean legal entity is needed

A license-holder must be a Korean company to

which MFDS grants an import approval.

• All devices are required for pre-market

listing or approvals

No medical devices exempted from pre-market

processes

• Disposables or implanted devices are

mostly reimbursed by government

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


Medical Device Approval Process

• Headquartered in O-Song, Chungbuk

- 120 km South of Seoul, capital city of Korea

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


Responsible Offices

17

Cardiovascular Device

Division

Orthopedic & Rehabilitation

Device Division

Oral & Digestive Device

Division

High-Tech Device Division

Medical Device Policy

Division

Medical Device

Management Division

Medical Device Quality

Division

In-Vitro Diagnostics Task Force

Medical Device Safety Bureau

Medical Device Evaluation Dept.

Ministry of Food &

Drug Safety (MFDS) National Institute of

Food & Drug Safety Evaluation

(NIFDS)


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


Pre-market Approval Pathways

Class I

Designated

equivalent product

E-listing to MFDS

Database

MFDS

Review times

Equivalent Product

Novel Product

Technical

Document Review

Technical &

Clinical Document

Review

Class II Technical document

review by third party

review body

Class

III & IV

10 days

• Regulatory pathways determined by class and similarity to

previously approved devices

10 days

80 days

65 days

80 days

25 days

No review

(1-2 months)

(Total timeframe

recommended for company)

(2-3 months)

(3-5 months)

(7-9 months)

(5-7 months)

(7-9 months) 19 © Synex Consulting, Ltd. November 2013

Pre-Market Processes for Class II, III, IV

Importer in Korea

Technical Documents

Review by MFDS

KGMP Certification to

Manufacturing Site by

MFDS

Ready to Sell

Certificate of product

approval by MFDS

Ready to Import

In case importer

and manufacturing

site already

KGMP-certified,

In case the

importer

or

the manufacturing

site is not KGMP-

certified, Upcoming Change in 2014!

KGMP certification must be

completed before product

approval.


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.

21

Information requested varies depending on class, regulatory pathway

and product characteristics


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


• 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

23

Acceptability of Foreign Test 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

• 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

24

Clinical Reports


• 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

KGMP Certification to Foreign Manufacturer


Pathways for KGMP certification

Class Manufacturing

site new to Korea

Adding new product

groups to an already

certified

manufacturing site or

a manufacturing site

change

Renewal

of KGMP certificate

Class 1 Document Review

Document Review

Document Review

Class 2 Site Audit by Third

Party Inspector

Document Review

Class 3 Site Audit by Third

Party Inspector and

MFDS

Site Audit by Third Party

Inspector

Class 4 Site Audit by Third Party

Inspector and MFDS


• 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

KGMP to Foreign Manufacturer Site inspection


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)


Post-Market Programs

• Five PMS Programs

• Tracking

• Re-evaluation through PMS study

• Adverse event / safety alert reporting

• Recall

• Re-examination


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

Product Approval


Manufacturing

Product Approval

Application

KGMP Certification

Application

2014

Product Approval

Application

KGMP Certification

Application

Product Approval


Manufacturing Site


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


For further information, please contact:

www.synex.co.kr

[email protected]

10th Floor Daejong Building

143-48, Samsung-dong, Gangnam-gu

Seoul 135-601, Korea

Phone 82-2-6202-3300

Fax 82-2-2040-6250

Thank you!