ul webinar - updates to the regulatory framework in korea and their impact to ivd and medical device...

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 1,1901,454

1,673

1,9672,123

1,879

2,2662,521 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

http://www.samsungmedison.co.kr/

http://www.gehealthcare.com/krko/uskorea/index.html

http://www.nugamedical.com/

http://www.siemens.co.kr/healthcare

http://www.vatech.co.kr/

http://www.siemens.co.kr/healthcare

http://www.ceragem.co.kr/

http://www.i-sens.co.kr/



http://www.dmo.co.kr/

http://en.osstem.com/


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

http://www.siemens.com/answers/kr/ko/

http://www.jnjmed.co.kr/

http://www.medtronic.co.kr/

http://www3.gehealthcare.co.kr/ko-KR



http://www.jnj-korea.co.kr/



http://www.covidien.com/kr/pages.aspx

http://www.philips.co.kr/

http://www.stryker.com/kr/index.htm

http://www.abbott.co.kr/

http://www.roche-diagnostics.co.kr/Pages/default.aspx




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

http://www.mfds.go.kr/eng/index.do

http://www.mfds.go.kr/medicaldevice/index.do





http://emed.mfds.go.kr/


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

http://emed.mfds.go.kr/kfda2

http://www.mditac.or.kr/

http://www.medinet.or.kr/

http://www.kmdia.or.kr/

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:

[email protected]

MinYong Choi (Seoul, Korea)

+82.2.2009.9366

[email protected]

ul webinar - updates to the regulatory framework in korea and their impact to ivd and medical device...

Health & Medicine