Global Medical Device Testing and Certification Market Size (2024 - 2029)

The medical device testing and certification market is experiencing growth driven by the need for compliance with diverse national and international regulatory standards, which ensures the safety and efficacy of medical devices. The market's expansion is influenced by the increasing demand for validation and verification processes, as well as the shift towards domestic manufacturing to mitigate supply chain disruptions exacerbated by events like the COVID-19 pandemic. However, the complexity and variability of regulatory requirements across different countries pose challenges that could hinder market growth.

Market Size of Global Medical Device Testing and Certification Industry

Single User License

$4750

Team License

$5250

Corporate License

$8750

Book before:
Medical Device Testing and Certification Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 10.57 Billion
Market Size (2029) USD 12.73 Billion
CAGR (2024 - 2029) 3.80 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Medical Device Testing and Certification Market Major Players

*Disclaimer: Major Players sorted in no particular order

Need a report that reflects how COVID-19 has impacted this market and its growth?

Single User License

$4750

Team License

$5250

Corporate License

$8750

Book before:

Medical Device Testing Market Analysis

The Global Medical Device Testing and Certification Market size is estimated at USD 10.57 billion in 2024, and is expected to reach USD 12.73 billion by 2029, growing at a CAGR of 3.80% during the forecast period (2024-2029).

During the COVID-19 outbreak in 2020, several measures were taken to prevent the transmission of diseases, such as lockdown measurements and restricting import-export activities between the countries, which disrupted the supply chain, thus, negatively impacting the overall market studied.

Moreover, the disruption caused due to COVID-19 in international supply chains has led to shortages of critical medical devices across the world. Therefore, many countries have taken definite measures to ease the shortages by importing equipment, such as domestic manufacturing of medical devices. Additionally, domestic manufacturing of essential medical devices is expected overcome trade barriers, at the same time, ensure product quality and market stability.

As per British Standards Institution (BSI), in February 2020, by taking into consideration the effects of the COVID-19 pandemic, the company reviewed processes and planned a program to minimize the risk to British Standards Institution (BSI) clients and colleagues while maintaining accreditation requirements and mitigating potential global trade risks.

The medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices. Therefore, it is compulsory for every device to comply with national and international standards before entering a market. The standard guidelines of medical devices vary from country to country, and it is mandatory for every manufacturer to follow these guidelines for marketing or selling their products in a country. For instance, the United States follows Food and Drug Administration (FDA) guidelines, Europe considers Conformitè Europëenne (CE) approval, Canada needs Health Canada Registration, and India requires approval from Central Drugs Standard Control Organisation (CDSCO). This diverse range of regulatory landscapes drives the testing and certification market.

Since regulations are different in every country, it is crucial for each medical device manufacturer to register or receive regulatory guidelines of that specific country, which, in turn, indicates the need for authorized third parties to register their devices. National regulatory authorities of every country prefer that the manufacturers selling their products in that particular country should comply with standard guidelines and get it checked by a third-party certification system.

This may result in propelling the testing and certification market, as well as increase easy market access. The other factors, such as the increasing need for validation and verification (V&V) for medical devices, are driving the medical device testing and certification market. However, a factor such as diversity in regulation is expected to impede market growth over the forecast period.

Medical Device Testing Industry Segmentation

As per the scope of the report, medical device testing, certification, and auditing are necessary to ensure the safety of the devices. These testing and certification can be provided by the third party under the recognized auditing organization. The global medical device testing and certification market are segmented by service type (testing services, inspection services, certification services, and other services), sourcing type (in-house and outsourced), device class (class I, class II, and class III), 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, and other technologies), and geography (North America, Europe, Asia Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

By Service Type
Testing Services
Inspection Services
Certification Services
Other Services
By Sourcing Type
In-house
Outsourced
By Device Class
Class I
Class II
Class III
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
Other Technologies
By Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa
GCC
South Africa
Rest of Middle East & Africa
South America
Brazil
Argentina
Rest of South America
Need A Different Region Or Segment?
Customize Now

Global Medical Device Testing and Certification Market Size Summary

The medical device testing and certification market is poised for steady growth over the forecast period, driven by the increasing demand for compliance with stringent regulatory standards across various regions. The market is influenced by the necessity for medical devices to meet national and international safety and efficacy standards before they can be marketed. This requirement is compounded by the diverse regulatory landscapes in different countries, such as the FDA in the United States, CE in Europe, and CDSCO in India, which necessitates the involvement of authorized third-party certification bodies. The COVID-19 pandemic highlighted the critical importance of medical device testing, as it led to a surge in demand for certain devices like ventilators and personal protective equipment, prompting regulatory bodies to expedite approvals and expand testing services. The pandemic also underscored the need for domestic manufacturing to mitigate supply chain disruptions, further emphasizing the role of testing and certification in ensuring product quality and market stability.

The market is characterized by a high level of consolidation, with a few key players dominating the landscape. However, the growing demand for medical devices and the increasing complexity of regulatory requirements are expected to attract more companies, including small to mid-sized enterprises, into the market. Regions such as North America are witnessing robust growth due to a strong focus on quality and the presence of major multinational companies. The market's expansion is also supported by strategic initiatives, such as laboratory expansions and acquisitions, aimed at enhancing testing capabilities and market reach. As the healthcare sector continues to evolve, the demand for comprehensive testing and certification services is anticipated to rise, driving the market's growth trajectory.

Explore More

Global Medical Device Testing and Certification Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Need of Validation and Verification (V&V) for Medical Devices

      2. 1.2.2 Compliance of Standards

    3. 1.3 Market Restraints

      1. 1.3.1 Diversity in Regulation

    4. 1.4 Industry Attractiveness - Porter's Five Forces Analysis

      1. 1.4.1 Bargaining Power of Buyers/Consumers

      2. 1.4.2 Bargaining Power of Suppliers

      3. 1.4.3 Threat of New Entrants

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION

    1. 2.1 By Service Type

      1. 2.1.1 Testing Services

      2. 2.1.2 Inspection Services

      3. 2.1.3 Certification Services

      4. 2.1.4 Other Services

    2. 2.2 By Sourcing Type

      1. 2.2.1 In-house

      2. 2.2.2 Outsourced

    3. 2.3 By Device Class

      1. 2.3.1 Class I

      2. 2.3.2 Class II

      3. 2.3.3 Class III

    4. 2.4 By Technology

      1. 2.4.1 Active Implant Medical Device

      2. 2.4.2 Active Medical Device

      3. 2.4.3 Non-active Medical Device

      4. 2.4.4 In Vitro Diagnostic Medical Device

      5. 2.4.5 Ophthalmic Medical Device

      6. 2.4.6 Orthopedic and Dental Medical Device

      7. 2.4.7 Other Technologies

    5. 2.5 By Geography

      1. 2.5.1 North America

        1. 2.5.1.1 United States

        2. 2.5.1.2 Canada

        3. 2.5.1.3 Mexico

      2. 2.5.2 Europe

        1. 2.5.2.1 Germany

        2. 2.5.2.2 United Kingdom

        3. 2.5.2.3 France

        4. 2.5.2.4 Italy

        5. 2.5.2.5 Spain

        6. 2.5.2.6 Rest of Europe

      3. 2.5.3 Asia-Pacific

        1. 2.5.3.1 China

        2. 2.5.3.2 Japan

        3. 2.5.3.3 India

        4. 2.5.3.4 Australia

        5. 2.5.3.5 South Korea

        6. 2.5.3.6 Rest of Asia-Pacific

      4. 2.5.4 Middle East & Africa

        1. 2.5.4.1 GCC

        2. 2.5.4.2 South Africa

        3. 2.5.4.3 Rest of Middle East & Africa

      5. 2.5.5 South America

        1. 2.5.5.1 Brazil

        2. 2.5.5.2 Argentina

        3. 2.5.5.3 Rest of South America

Global Medical Device Testing and Certification Market Size FAQs

The Global Medical Device Testing and Certification Market size is expected to reach USD 10.57 billion in 2024 and grow at a CAGR of 3.80% to reach USD 12.73 billion by 2029.

In 2024, the Global Medical Device Testing and Certification Market size is expected to reach USD 10.57 billion.

Medical Device Testing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)