Market Study – Medtech Industry in Korea. December 2012. osec.ch
Medtech Industry in Korea. Title.
Medtech Industry in Korea.
Language.
English
Number of pages.
75 pages
Content.
The report provides insights into Korea’s growing market for medical devices. This includes an overview, outlook, such as the shift from treatment to prevention, characteristics, policy and strategy. The role government plays is discussed and information on key regulations as well as information on import procedures are included in the report. The section on the Korean Medtech sector includes the Dental Industry, Orthopedics and Trauma, Disposable Goods, Reusable Instruments, Rehabilitation Machines, Laboratory Machines & InVitro Diagnostics and Ophthalmologic Devices (market data, key players, incl. foreign). A full section of the report is dedicated to show where market opportunities for Swiss SMEs in the medical device market in Korea exist. Recommendations for market entry are given. With an import dependency of 65% and considerable market growth from USD 2,019 million in 2006 to USD 2,956 million in 2011 and a projected USD 4,030million in 2016, a number of opportunities exist in the growing Korean medical device market for dedicated Swiss SMEs with a long-term market view.
Author.
Other Industry Reports.
2
| Medtech Industry in Korea
Mr. Yongha Na, President, Medipert
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Content. 1.
EXECUTIVE SUMMARY .................................................................................................. 7
2.
MEDICAL DEVICE INDUSTRY OVERVIEW & TREND ................................................... 8
2.1 2.1.1 2.1.2
MEDICAL DEVICE INDUSTRY TREND .................................................................................................................... 8 Paradigm Shift ................................................................................................................................................. 8 Industry - Technology Trend ............................................................................................................................ 9
2.2 2.2.1 2.2.1.1 2.2.1.2 2.2.2 2.2.2.1 2.2.2.2 2.2.2.3 2.2.2.4 2.2.2.5 2.2.2.6 2.2.3 2.2.4 2.2.5
OVERVIEW AND OUTLOOK FOR MEDICAL DEVICE M ARKET IN KOREA................................................................... 9 Overview ......................................................................................................................................................... 9 Demographics and National Medical Expense ............................................................................................. 11 Health Workforce and Medical Institutions Trend ......................................................................................... 12 Overview of Korea Medical Device Market ................................................................................................. 14 Korea Medical Device Market Size ............................................................................................................... 14 Ratio of Medical Device Industry among Total Industry ................................................................................ 15 The Number of Companies in Medical Device Industry ................................................................................ 15 The Number of Employees Working in Medical Device Companies ............................................................ 15 The Number of Registered Medical Device Products ................................................................................... 16 Medical Device Production by Classification ................................................................................................ 16 Medical Device Trade Trend ......................................................................................................................... 17 Medical Institutions’ Domestic Medical Device Purchasing Rate.................................................................. 19 Korean Medical Devices by Sector ............................................................................................................... 19
2.3 2.3.1 2.3.2 2.3.3 2.3.4
DISTINGUISHED CHARACTERISTICS OF KOREA MEDICAL DEVICE INDUSTRY ....................................................... 21 Vulnerable Industry Structure & Trade Deficit ............................................................................................... 21 Immature Technology Level .......................................................................................................................... 21 IT Convergence Medical Information System, Oriental Medicine Device Development .............................. 22 Conglomerates Entering into Medical Device Market ................................................................................... 22
2.4 2.4.1 2.4.2 2.4.2.1 2.4.2.2 2.4.2.3 2.4.2.4 2.4.3 2.4.4
POLICY AND STRATEGY ................................................................................................................................... 22 Medical Device Registration Regulation Improvement ................................................................................. 22 R&D Project Plan .......................................................................................................................................... 23 Consumer Affiliated Core Strategy Product Development Expansion .......................................................... 23 Business Support Infrastructure Establishment ............................................................................................ 23 Medical Device Win-Win Forum .................................................................................................................... 23 Advanced Clinical Trial Capability Establishment ......................................................................................... 24 rd Propulsion of IEC60601-1 3 Edition ............................................................................................................ 24 Rebate Dual Punishment .............................................................................................................................. 25
3.
THE ROLE OF GOVERNMENT ..................................................................................... 27
3.1 3.1.1 3.1.2
GOVERNMENT ORGANIZATIONS FOR MEDICAL DEVICE INDUSTRY ...................................................................... 27 Medical Device Organization within KFDA ................................................................................................... 28 Umbrella Organization of KFDA .................................................................................................................... 28
3.2 3.3 3.3.1 3.3.2 3.3.2.1
HISTORY OF MEDICAL DEVICE M ANAGEMENT SYSTEM ...................................................................................... 29 MEDICAL DEVICE REGULATIONS ...................................................................................................................... 29 Key Regulations on Medical Devices ............................................................................................................ 29 Definition of Medical Device and Its Classification........................................................................................ 30 The definition of Medical Device ................................................................................................................... 30
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3.3.2.2 Classification of Medical Device.................................................................................................................... 30 3.3.2.3 Classification by Name of the Product .......................................................................................................... 31 3.4 3.4.1 3.4.1.1 3.4.1.2 3.4.1.3 3.4.1.4 3.4.1.5 3.4.1.6 3.4.2 3.4.2.1 3.4.2.2 3.4.2.3 3.4.2.4 3.4.2.5 3.4.3 3.4.4 3.4.4.1 3.4.4.2 3.4.4.3
IMPORT PROCEDURE OF MEDICAL DEVICE ........................................................................................................ 32 Product Registration ...................................................................................................................................... 32 Products Subject to Approval vs. Notification ............................................................................................... 32 Product Approval Review Period & Fee ........................................................................................................ 33 Pre-market Notification .................................................................................................................................. 33 Pre-market Approval ..................................................................................................................................... 33 Required Documentation for Product Approval Evaluation ........................................................................... 35 Requirements for Clinical Trial Application .................................................................................................... 36 GMP Procedure............................................................................................................................................. 37 Overview ....................................................................................................................................................... 37 History of Korean GMP ................................................................................................................................. 38 GMP Inspection Standards ........................................................................................................................... 38 GMP Inspection Type .................................................................................................................................... 38 Dossier for GMP Inspection .......................................................................................................................... 38 Device Business License (DBL) .................................................................................................................... 39 Medical Device Handler ................................................................................................................................ 39 Medical Device Manufacturer and Importer .................................................................................................. 39 Medical Device Refurbisher .......................................................................................................................... 40 Medical Device Distributor or Renter ............................................................................................................ 40
3.5 3.5.1 3.5.2 3.5.3
HEALTH INSURANCE ........................................................................................................................................ 40 Health Insurance Medical Treatment Materials ............................................................................................. 40 Treatment Material Registration Procedure .................................................................................................. 42 Treatment Material Reevaluation .................................................................................................................. 42
4.
KOREAN MEDTECH SECTOR ...................................................................................... 44
4.1 4.1.1 4.1.2 4.1.3
HOSPITAL INSTALLATIONS ................................................................................................................................ 44 Hospital Installations Market Size ................................................................................................................. 44 Number of Companies in Hospital Installations Market ................................................................................ 45 Key Player ..................................................................................................................................................... 45
4.2 4.2.1 4.2.2 4.2.3 4.2.4
DENTAL INDUSTRY ........................................................................................................................................... 45 Dental Market Size ........................................................................................................................................ 45 Number of Companies in Dental Market ....................................................................................................... 46 Key Players ................................................................................................................................................... 46 Major Foreign Suppliers of Dental Devices ................................................................................................... 46
4.3 4.3.1 4.3.2 4.3.3 4.3.4
ORTHOPEDICS AND TRAUMA ............................................................................................................................ 47 Orthopedics and Trauma market size ........................................................................................................... 47 The Number of Companies in Orthopedics and Trauma market .................................................................. 47 Key Players ................................................................................................................................................... 47 Major Foreign Suppliers of Orthopedics and Trauma market ....................................................................... 48
4.4 4.4.1 4.4.2 4.4.3 4.4.4
DISPOSABLE GOODS ....................................................................................................................................... 48 Disposable Goods Market Size ..................................................................................................................... 48 Number of Companies in Disposable Goods ................................................................................................ 49 Key Players ................................................................................................................................................... 49 Major Foreign Suppliers of Disposable goods market .................................................................................. 49
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| Medtech Industry in Korea
4.5 4.5.1 4.5.2 4.5.3 4.5.4
REUSABLE INSTRUMENTS ................................................................................................................................ 50 Reusable Instruments Market Size ............................................................................................................... 50 Number of Companies in Reusable Instrument ............................................................................................ 50 Key Players ................................................................................................................................................... 50 Major Foreign Suppliers of Reusable Instruments market ............................................................................ 50
4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5
REHABILITATION M ACHINES ............................................................................................................................. 51 Rehabilitation Machines Market Size ............................................................................................................ 51 Number of Companies in Rehabilitation Machines ....................................................................................... 51 Key Players ................................................................................................................................................... 52 Major Foreign Suppliers of Reusable Instruments Market ............................................................................ 52 Level of Technology in Rehabilitation Devices .............................................................................................. 52
4.7 4.7.1 4.7.2 4.7.3 4.7.4
LABORATORY M ACHINES & IN-VITRO DIAGNOSTICS .......................................................................................... 53 Laboratory Machines & In-Vitro Diagnostic Market Size............................................................................... 53 Number of Companies in Laboratory Machines & In-Vitro Diagnostics ........................................................ 53 Key Players ................................................................................................................................................... 53 Major Foreign Suppliers of Laboratory Machines & In-Vitro Diagnostic ....................................................... 53
4.8 4.8.1 4.8.2 4.8.3 4.8.4
OPHTHALMOLOGIC DEVICES ............................................................................................................................ 54 Ophthalmologic Devices Market Size ........................................................................................................... 54 Number of Companies in Ophthalmologic Devices ...................................................................................... 54 Key Players ................................................................................................................................................... 54 Major Foreign Suppliers of Ophthalmologic Devices .................................................................................... 55
5.
OPPORTUNITIES FOR SWISS SMES........................................................................... 56
5.1
Overview ...................................................................................................................................................... 56
5.2 5.2.1 5.2.2 5.2.3 5.2.4
SWISS COMPANIES IN KOREAN MEDICAL DEVICE M ARKET ................................................................................ 56 Korean Medical Device Market Size & Swiss Medical Device Export to Korea ........................................... 56 Korea’s Medical Device Import Value and Amount by Product Classification .............................................. 56 Import Value & Amount by Product Classification ......................................................................................... 57 Top 30 Swiss Companies present in Korea .................................................................................................. 58
5.3 5.3.1 5.3.2 5.3.3
SUGGESTIONS AND RECOMMENDATIONS FOR SWISS COMPANIES PLANNING TO PENETRATE KOREAN M ARKET... 59 Understanding of Regulatory Requirements ................................................................................................. 59 Preparation to GMP Inspections for Manufacturing Site ............................................................................... 59 Preparation to IEC 60601-1 3rd Edition ........................................................................................................ 60
5.4 5.4.1 5.4.2 5.4.3 5.4.4
OPPORTUNITIES .............................................................................................................................................. 60 Market Entry through Multi-National Clinical Trial ......................................................................................... 60 Strategic Alliance through OEM with Korean Medical Device Manufacturer ................................................ 60 Technical Partnership with Korean Medical Device Manufacturers .............................................................. 61 Prospective Products .................................................................................................................................... 61
6.
CONCLUSION. ............................................................................................................... 63
7.
APPENDIX...................................................................................................................... 64
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Appendix1.
Appendix2. Appendix3. Appendix4. Appendix5. Appendix6.
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Top 30 Production Products by Value Top 30 Export Products by Value Top 30 Import Products by Value Product Categories Scope of Acceptable Economic Benefit based on Enforcement Regulation of the Medical Dice Rebate Dual Punishment The documents to be submitted Technical file review Application Source and Reference Site
| Medtech Industry in Korea
1. Executive Summary. As Korea enters into aging society, and peoplesâ&#x20AC;&#x2122; demand for better health and welfare as well as higher quality of life increases, the expense for health and medical treatment in Korea is growing every day. As the medical device in modern society is the essential element in providing health and welfare services, the expense spent to purchase medical devices is also increasing. Since the medical device paradigm is shifting from treatment to prevention and health care, the medical expense and medical device market size is continuously expanding and is expected to grow in the future, also. - Medical Device Market Size (Espicom) : 2006 USD 2,019 million -> 2011 USD 2,956 million -> 2016 USD 4,030million Korean medical device industry in 2011 recorded USD 3,038 million of production and USD 1,673 million of export. However, it still depends 65% of its demand on imported products due to its low competitiveness generated from its lack of technology, capital, and awareness. There are around 2,000 medical device manufacturing companies. 78% of them produce less than USD 0.9 million amount, and 70% of them are hiring less than 100 employees. Koreaâ&#x20AC;&#x2122;s chronic trade deficit is persisting that in 2011 it recorded USD 848 million To cope with the business environmental change such as FTA, Korean government is improving the medical device registration regulation, and establishing business support infrastructure to secure competitiveness. The Korean medical device market is still considered as a challenging market for foreign companies, however such challenge can be easily overcome by understanding its market trend (which is continuously expanding) and device related regulation. In this report, applied exchange rate is referred to Korea Exchange Bankâ&#x20AC;&#x2122;s Annual Average Exchange Rate. Some figures are rounded off by its marking unit that the total may not be exactly match to original figure. . <Annual Average Exchange Rate by Year> (unit : KRW) 2004 2005 2006 2007 2008 2009 2010 2011 Currency 1 USD
1,144.67
1,024.31
955.51
929.20
1,102.59
1,276.40
1,156.26
1,108.11
Source: Bank of Korea
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