[시장보고서]의료기기 검사 및 인증 시장 : 서비스 유형별, 조달 유형별, 기기 클래스별, 기술별, 지역별

의료기기 검사 및 인증 시장 : 서비스 유형별, 조달 유형별, 기기 클래스별, 기술별, 지역별

Medical Device Testing and Certification Market, By Service Type, By Sourcing Type, By Device Class, By Technology, and By Geography

상품코드 : 1747304

리서치사 : Coherent Market Insights

발행일 : 2025년 05월

페이지 정보 : 영문

라이선스 & 가격 (부가세 별도)

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한글목차

샘플 요청 목록에 추가

의료기기 검사 및 인증 시장은 2025년에 109억 5,790만 달러 시장 규모를 유지하고 2032년에는 147억 1,360만 달러에 이를 것으로 예측됩니다. 2025년부터 2032년까지 연평균 복합 성장률(CAGR)은 4.3%로 예측됩니다.

보고서 범위		보고서 상세
기준 연도	2024년	2025년 시장 규모	109억 5,790만 달러
실적 데이터	2020-2024년	예측 기간	2025-2032년
예측 기간(2025-2032년) CAGR	4.30%	2032년 가치 예측	147억 1,360만 달러

의료기기 검사 및 인증은 의료기기의 안전성과 유효성을 보장하기 위해 필요합니다. 미국은 식품의약국(FDA)의 가이드라인을 따르고, 캐나다는 캐나다 보건부(Health Canada)의 등록이 필요하며, 유럽은 유럽 적합성(CE) 승인을 고려하고, 인도는 중앙의약품표준관리기구(CDSCO)의 승인이 필요합니다.

시장 역학:

의료기기 검사 및 인증에 대한 관심 증가, 엄격한 정부 규제, 의료기기에서 인공지능(AI)과 사물인터넷(IoT)의 통합 증가, 코로나19의 발생은 예측 기간 동안 세계 의료기기 검사 및 인증 시장의 성장을 가속할 것으로 예상되는 주요 요인입니다.

예를 들어, 2022년 1월, TUV SUD는 미네소타주 뉴브라이트에 의료기기 시험소를 확장했습니다. 이 최신식 시험소는 모든 의료기기에 대한 엔드 투 엔드 테스트 솔루션을 제공하며, TUV SUD의 현재 활발한 의료기기 테스트 역량을 보완하는 다양한 의료기기 생물학적 및 화학적 테스트도 수행할 예정입니다.

본 조사의 주요 특징

이 보고서는 2024년을 기준 연도, 2025년부터 2032년까지의 예측 기간 동안 시장 규모와 연평균 성장률(CAGR)을 제공하는 세계 의료기기 검사 및 인증 시장을 상세하게 분석하여 예측했습니다.
또한, 다양한 부문에 걸친 잠재적 수익 기회를 밝히고, 이 시장의 매력적인 투자 제안 매트릭스를 설명합니다.
또한 시장 성장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업의 경쟁 전략 등에 대한 주요 고찰을 제공합니다.
이 보고서는 기업 하이라이트, 제품 포트폴리오, 주요 하이라이트, 재무 성과, 전략 등의 매개 변수를 기반으로 세계 의료기기 시험 및 인증 시장의 주요 기업 프로파일을 제공합니다.
이 보고서의 통찰력을 통해 마케팅 담당자와 기업 경영진은 향후 제품 출시, 유형 업그레이드, 시장 확대, 마케팅 전술에 대한 정보에 입각한 의사결정을 내릴 수 있습니다.
세계 의료기기 검사 및 인증 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 시장 진출기업, 재무 분석가 등 업계의 다양한 이해관계자를 대상으로 합니다.
이해관계자들은 세계 의료기기 검사 및 인증 시장 분석에 사용되는 다양한 전략 매트릭스를 통해 의사결정을 용이하게 할 수 있습니다.

Medistri SA
BSI Group
Ente Certificazione Macchine
GMED
IMQ Group SRL
TOXIKON
TUV SUD
WuXi AppTec
Pace Analytical Services LLC
Gateway Analytical LLC
Boston Analytical
Bureau Veritas
UL LLC
TUV Rheinland
SGS SA
Intertek Group PLC
Eurofins Scientific
Element Materials Technology
Dekra Testing and Certification GmbH
Institute for testing and Certification Inc.

제11장 섹션

조사 방법
출판사에 대해

LSH

영문 목차

영문목차

Medical Device Testing and Certification Market is poised to hold a valuation of USD 10,957.9 Mn in 2025 and is expected to reach USD 14,713.6 Mn in 2032. The market is expected to exhibit a CAGR of 4.3% from 2025 to 2032.

Report Coverage		Report Details
Base Year:	2024	Market Size in 2025:	USD 10,957.9 Mn
Historical Data for:	2020 To 2024	Forecast Period:	2025 To 2032
Forecast Period 2025 to 2032 CAGR:	4.30%	2032 Value Projection:	USD 14,713.6 Mn

Medical device testing and certification is necessary to ensure safety and effectiveness of medical devices. The U.S. follows the Food and Drug Administration (FDA) guidelines, Canada needs the Health Canada Registration, Europe considers Conformite Europeenne (CE) approval, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).

Market Dynamics:

Rise in focus on the medical device testing and certification, stringent government regulations, rise in integration of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices, and the outbreak of COVID-19 are major factors expected to drive growth of the global medical device testing and certification market during the forecast period.

For instance, in January 2022, TUV SUD expanded its medical device testing laboratory in New Brighton, Minnesota. The state-of-the-art laboratory will offer an end-to-end testing solution for all medical devices and will also provide a wide range of biological and chemical testing of medical devices that complements TUV SUD's current active medical device testing capabilities.

Key features of the study:

This report provides in-depth analysis of the global medical device testing and certification market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period 2025-2032, considering 2024 as the base year.
It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
It profiles key players in the global medical device testing and certification market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
Key companies covered as a part of this study include Medistri SA, BSI Group, GMED, IMQ Group SRL, TOXIKON, TUV SUD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, Ente Certificazione Macchine, and Institute for testing and Certification Inc., among others.
Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
The global medical device testing and certification market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global medical device testing and certification market.

Detailed Segmentation:

Global Medical Device Testing and Certification Market, By Service Type
- Testing Services
- Inspection Services
- Certification Services
Global Medical Device Testing and Certification Market, By Sourcing Type
- In-house
- Outsourced
Global Medical Device Testing and Certification Market, By Device Class
- Class I
- Class II
- Class III
Global Medical Device Testing and Certification Market, By Technology
- Active Implant Medical Device
- Active Medical Device
- Non-Active Medical Device
- In-Vitro Diagnostic Medical Device
- Ophthalmic Medical Device
- Orthopedic and Dental Medical Device
- Vascular Medical Device
- Other Technologies
Global Medical Device Testing and Certification Market, By Geography
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
Company Profiles
- Medistri SA
- BSI Group
- Ente Certificazione Macchine
- GMED
- IMQ Group SRL
- TOXIKON
- TUV SUD
- WuXi AppTec
- Pace Analytical Services LLC
- Gateway Analytical LLC
- Boston Analytical
- Bureau Veritas
- UL LLC
- TUV Rheinland
- SGS SA
- Intertek Group PLC
- Eurofins Scientific
- Element Materials Technology
- Dekra Testing and Certification GmbH
- Institute for testing and Certification Inc.

Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Inspection Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Certification Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

6. Global Medical Device Testing and Certification Market, By Sourcing Type, 2020-2032, (US$ Mn)

Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
In-house
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Outsourced
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

7. Global Medical Device Testing and Certification Market, By Device Class, 2020-2032, (US$ Mn)

Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
Class I
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Class II
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Class III
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

8. Global Medical Device Testing and Certification Market, By Technology, 2020-2032, (US$ Mn)

Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
Active Implant Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Non-Active Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
In-Vitro Diagnostic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Ophthalmic Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Orthopedic and Dental Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Vascular Medical Device
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
Other Technologies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

9. Global Medical Device Testing and Certification Market, By Geography, 2020-2032, (US$ Mn)

Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)
Middle East & Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Services Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Sourcing Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Device Class, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Technology, 2020-2032,(US$ Mn)

10. Competitive Landscape

Medistri SA
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
BSI Group
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Ente Certificazione Macchine
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
GMED
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
IMQ Group SRL
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
TOXIKON
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
TUV SUD
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
WuXi AppTec
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Pace Analytical Services LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Gateway Analytical LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Boston Analytical
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Bureau Veritas
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
UL LLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
TUV Rheinland
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
SGS SA
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Intertek Group PLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Eurofins Scientific
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Element Materials Technology
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Dekra Testing and Certification GmbH
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Institute for testing and Certification Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Analyst Views

11. Section

Research Methodology
About us

한글목차

시장 역학:

본 조사의 주요 특징

목차 :

제1장 조사 목적과 전제조건

제2장 시장 전망

제3장 시장 역학, 규제, 동향 분석

제4장 세계의 의료기기 검사 및 인증 시장 - 코로나바이러스(COVID-19) 팬데믹의 영향

제5장 세계의 의료기기 검사 및 인증 시장, 서비스 유형별, 2020년-2032년

제6장 세계의 의료기기 검사 및 인증 시장, 조달 유형별, 2020년-2032년

제7장 세계의 의료기기 검사 및 인증 시장(기기 클래스별, 2020년-2032년)

제8장 세계의 의료기기 검사 및 인증 시장, 기술별, 2020년-2032년

제9장 세계의 의료기기 검사 및 인증 시장, 지역, 2020년-2032년

제10장 경쟁 구도

제11장 섹션

영문목차

Market Dynamics:

Key features of the study:

Detailed Segmentation:

Table of Contents:

1. Research Objectives and Assumptions

2. Market Purview

3. Market Dynamics, Regulations, and Trends Analysis

4. Global Medical Device Testing and Certification Market - Impact of Coronavirus (COVID-19) Pandemic