醫療設備測試和認證市場（按服務類型、採購類型、設備類別、技術和地區分類）

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

出版日期: 2025年05月13日 | 出版商:

Coherent Market Insights | 英文 172 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

預計醫療設備測試和認證市場在 2025 年將保持 109.579 億美元的市場規模，到 2032 年將達到 147.136 億美元，2025 年至 2032 年的複合年成長率為 4.3%。

報告範圍		報告詳細資訊
基準年	2024	2025年的市場規模	109.579億美元
效能數據	從2020年到2024年	預測期	2025年至2032年
預測期：2025-2032年複合年成長率：	4.30%	2032年價值預測	147.136億美元

醫療設備測試和認證對於確保其安全性和有效性至關重要。美國遵循食品藥物管理局( FDA) 的指導方針，加拿大要求在加拿大衛生署註冊，歐洲考慮歐洲符合性 (CE) 認證，印度則要求獲得中央藥品標準控制組織 (CDSCO) 的批准。

市場動態：

對醫療設備測試和認證的關注度不斷提高、政府法規越來越嚴格、人工智慧 (AI) 和物聯網 (IoT) 在醫療設備中的日益融合以及 COVID-19 疫情是預計在預測期內推動全球醫療設備測試和認證市場成長的關鍵因素。

例如，2022年1月，TUV SUD擴建了位於明尼蘇達州新布萊頓的醫療設備檢測實驗室。這座先進的檢測設施將為所有醫療設備提供端到端的檢測解決方案，並將對醫療設備，從而補充TUV SUD現有的主動醫療設備檢測能力。

本研究的主要特點

本報告對全球醫療設備測試和認證市場進行了詳細分析，並以 2024 年為基準年，提供了 2025 年至 2032 年預測期的市場規模和年複合成長率(CAGR)。
它還強調了各個領域的潛在商機，並說明了該市場的有吸引力的投資提案矩陣。
它還提供了有關市場促進因素、限制因素、機會、新產品發布和核准、市場趨勢、區域前景和主要企業採用的競爭策略的主要考察。
該報告涵蓋了全球醫療設備測試和認證市場的主要企業概況，基於以下參數，例如公司亮點、產品系列、關鍵亮點、財務表現和策略。
本報告的見解將使負責人和公司經營團隊能夠就未來的產品發布、類型升級、市場擴張和行銷策略做出明智的決策。
全球醫療設備測試與認證市場報告針對該行業的各個相關人員，包括投資者、供應商、產品製造商、經銷商、新進業者和金融分析師。
相關人員可以透過用於分析全球醫療設備測試和認證市場的各種策略矩陣來促進他們的決策。

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.

第 11 章章節

調查方法
關於出版商

簡介目錄

Product Code: CMI5665

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