Summary

Executive Summary

Azoth Analytics has released a research report titled “Global Medical Device Regulatory Affairs Market (2024 Edition)” which provides a complete analysis of the Global Medical Device Regulatory Affairs industry in terms of market segmentation By Type (Diagnostic, Therapeutic), By Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Other Services), By Service Provider (Outsource, In-house) for the historical period of 2020-2023, the estimates of 2024 and the forecast period of 2025-2030.

The report analyses the Medical Device Regulatory Affairs Market by Region (Americas, Europe, Asia Pacific, Middle East & Africa) and 10 Countries (United States, Canada, United Kingdom, Germany, France, Italy, China, Japan, India, South Korea). The Global Medical Device Regulatory Affairs market showcased growth at a CAGR of 12.98% during 2020-2023. The market was valued at USD 6.86 Billion in 2023 which is expected to reach USD 27.58 Billion in 2030. The Medical Device Regulatory Affairs Market is influenced by factors such as evolving regulatory requirements, technological advancements in medical device development, globalization of markets, and increasing focus on patient safety and product quality.

According to World Health Organization (WHO), Noncommunicable diseases (NCDs) kill 41 million people each year, equivalent to 74% of all deaths globally. Cardiovascular diseases, including coronary artery disease, peripheral artery disease, and cardiac arrhythmias, continue to be leading causes of morbidity and mortality globally. As the prevalence of risk factors such as obesity, diabetes, and hypertension increases, so does the incidence of cardiovascular diseases. Non-communicable diseases often require continuous monitoring and management to prevent complications and improve patient outcomes. As the prevalence of NCDs rises, there is an increasing demand for medical devices for diagnosis, monitoring, and management of these conditions. Regulatory affairs professionals play a crucial role in ensuring that these devices meet regulatory requirements for safety, efficacy, and performance before they can be marketed and used in clinical settings.

Recognizing the need to facilitate international trade and harmonize regulatory requirements, regulatory authorities around the world are working to align their standards and regulations for medical devices. Initiatives such as the International Medical Device Regulators Forum (IMDRF) aim to promote convergence and mutual recognition of regulatory requirements, reducing duplication of efforts and facilitating market access for medical devices across multiple jurisdictions.

Advances in genomics, biomarkers, and diagnostic technologies are driving the emergence of personalized and precision medicine approaches in therapeutic interventions. Regulatory affairs professionals collaborate with developers of personalized medical devices, such as genetic tests and companion diagnostics, to ensure regulatory compliance and evidence-based validation of clinical utility and effectiveness.

Automated authoring and publishing tools automate repetitive tasks in regulatory writing and publishing, such as document formatting, template creation, and generation of submission-ready documents. These tools improve productivity, accuracy, and consistency in regulatory document preparation, reducing manual errors and time-to-market for medical devices. Regulatory affairs professionals can focus on content creation and regulatory strategy, while automated tools handle formatting and publishing tasks efficiently.

Cloud-based collaboration platforms facilitate seamless communication, document sharing, and project management between medical device companies and outsource service providers. These platforms enable real-time collaboration on regulatory affairs projects, regardless of geographic location. Cloud-based collaboration platforms enhance transparency, efficiency, and accountability in outsourcing relationships. Medical device companies can securely share documents, track project progress, and communicate with outsource service providers, facilitating effective collaboration and project management.

Scope of the Report:

• The report analyses the Medical Device Regulatory Affairs Market by Value (USD Million).
• The report analyses the Medical Device Regulatory Affairs Market by Region (Americas, Europe, Asia Pacific, Middle East & Africa) and 10 Countries (United States, Canada, United Kingdom, Germany, France, Italy, China, Japan, India, South Korea).
• The report presents the analysis of Medical Device Regulatory Affairs Market for the historical period of 2020-2023, the estimated year 2024 and the forecast period of 2025-2030.
• The report analyses the Medical Device Regulatory Affairs Market by type (Diagnostic, Therapeutic).
• The report analyses the Medical Device Regulatory Affairs Market by services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Other Services).
• The report analyses the Medical Device Regulatory Affairs Market by service provider (Outsource, In-house).
• The key insights of the report have been presented through the frameworks of SWOT and Porter’s Five Forces Analysis. Also, the attractiveness of the market has been presented by region, by type, by service, & by service provider.
• Also, the major opportunities, trends, drivers, and challenges of the industry has been analyzed in the report.
• The report tracks competitive developments, strategies, mergers and acquisitions and new product development. The companies analysed in the report include ICON Plc, Labcorp, IQVIA, Intertek Group Plc, SGS SA, Integer Holdings Corp, Medpace Holdings, Emergo, Freyr Solutions, and Promedica International.

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Table of Contents

Table of Content

1. Market Background
1.1 Scope and Product Outlook
1.2 Executive Summary
1.3 Research Methodology

2. Strategic Recommendations
2.1 Introduce niche offering for different end-use sectors
2.2 Focus on deploying different subscription models

3. Global Medical Device Regulatory Affairs Market: Historic and Forecast

3.1 Impact Analysis of Macro Economic Factors on Global Medical Device Regulatory Affairs Market
3.2 Recall Status by Device and Recall Characteristics
3.3 Duration from Recall initiation to termination
3.4 Global Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
3.5 Degree of Impact of Covid-19 on Medical Device Regulatory Affairs Market
3.6 Global Medical Device Regulatory Affairs Market Segmentation: By Type
3.6.1 Global Medical Device Regulatory Affairs Market, By Type Overview
3.6.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Type Overview
3.6.3 Global Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
3.6.4 Global Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
3.7 Global Medical Device Regulatory Affairs Market Segmentation: By Services
3.7.1 Global Medical Device Regulatory Affairs Market, By Services Overview
3.7.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Services Overview
3.7.3 Global Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
3.7.4 Global Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
3.7.5 Global Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
3.7.6 Global Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
3.8 Global Medical Device Regulatory Affairs Market Segmentation: By Service Provider
3.8.1 Global Medical Device Regulatory Affairs Market, By Service Provider Overview
3.8.2 Global Medical Device Regulatory Affairs Market Attractiveness Index, By Service Provider Overview
3.8.3 Global Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
3.8.4 Global Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)

4. Global Medical Device Regulatory Affairs Market, Region Analysis
4.1 Regional Coverage of the Study
4.2 Regional Snapshot

5. Americas Medical Device Regulatory Affairs Market: Historic and Forecast

5.1 Americas Medical Device Regulatory Affairs Market: Snapshot
5.2 Americas Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.3 Americas Medical Device Regulatory Affairs Market: Key Factors
5.4 Americas Medical Device Regulatory Affairs Market: Segment Analysis
5.5 Americas Medical Device Regulatory Affairs Market Segmentation: By Type
5.5.1 Americas Medical Device Regulatory Affairs Market, By Type Overview
5.5.2 Americas Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
5.5.3 Americas Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
5.6 Americas Medical Device Regulatory Affairs Market Segmentation: By Services
5.6.1 Americas Medical Device Regulatory Affairs Market, By Services Overview
5.6.2 Americas Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
5.6.3 Americas Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
5.6.4 Americas Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
5.6.5 Americas Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
5.7 Americas Medical Device Regulatory Affairs Market Segmentation: By Service Provider
5.7.1 Americas Medical Device Regulatory Affairs Market, By Service Provider Overview
5.7.2 Americas Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
5.7.3 Americas Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
5.8 Americas Medical Device Regulatory Affairs Market Segmentation: By Country
5.8.1 Europe Medical Device Regulatory Affairs Market, By Country Overview
5.8.2 United States Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.2.1 United States Medical Device Regulatory Affairs Market, By Type
5.8.2.2 United States Medical Device Regulatory Affairs Market, By Services
5.8.2.3 United States Medical Device Regulatory Affairs Market, By Service Provider
5.8.3 Canada Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.3.1 Canada Medical Device Regulatory Affairs Market, By Type
5.8.3.2 Canada Medical Device Regulatory Affairs Market, By Services
5.8.3.3 Canada Medical Device Regulatory Affairs Market, By Service Provider
5.8.4 Rest of Americas Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
5.8.4.1 Rest of Americas Medical Device Regulatory Affairs Market, By Type
5.8.4.2 Rest of Americas Medical Device Regulatory Affairs Market, By Services
5.8.4.3 Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider

6. Europe Medical Device Regulatory Affairs Market: Historic and Forecast

6.1 Europe Medical Device Regulatory Affairs Market: Snapshot
6.2 Europe Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.3 Europe Medical Device Regulatory Affairs Market: Key Factors
6.4 Europe Medical Device Regulatory Affairs Market: Segment Analysis
6.5 Europe Medical Device Regulatory Affairs Market Segmentation: By Type
6.5.1 Europe Medical Device Regulatory Affairs Market, By Type Overview
6.5.2 Europe Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
6.5.3 Europe Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
6.6 Europe Medical Device Regulatory Affairs Market Segmentation: By Services
6.6.1 Europe Medical Device Regulatory Affairs Market, By Services Overview
6.6.2 Europe Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
6.6.3 Europe Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
6.6.4 Europe Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
6.6.5 Europe Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
6.7 Europe Medical Device Regulatory Affairs Market Segmentation: By Service Provider
6.7.1 Europe Medical Device Regulatory Affairs Market, By Service Provider Overview
6.7.2 Europe Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
6.7.3 Europe Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
6.8 Europe Medical Device Regulatory Affairs Market Segmentation: By Country
6.8.1 Europe Medical Device Regulatory Affairs Market, By Country Overview
6.8.2 United Kingdom Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.2.1 United Kingdom Medical Device Regulatory Affairs Market, By Type
6.8.2.2 United Kingdom Medical Device Regulatory Affairs Market, By Services
6.8.2.3 United Kingdom Medical Device Regulatory Affairs Market, By Service Provider
6.8.3 Germany Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.3.1 Germany Medical Device Regulatory Affairs Market, By Type
6.8.3.2 Germany Medical Device Regulatory Affairs Market, By Services
6.8.3.3 Germany Medical Device Regulatory Affairs Market, By Service Provider
6.8.4 France Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.4.1 France Medical Device Regulatory Affairs Market, By Type
6.8.4.2 France Medical Device Regulatory Affairs Market, By Services
6.8.4.3 France Medical Device Regulatory Affairs Market, By Service Provider
6.8.5 Italy Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.5.1 Italy Medical Device Regulatory Affairs Market, By Type
6.8.5.2 Italy Medical Device Regulatory Affairs Market, By Services
6.8.5.3 Italy Medical Device Regulatory Affairs Market, By Service Provider
6.8.6 Rest of Europe Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
6.8.6.1 Rest of Europe Medical Device Regulatory Affairs Market, By Type
6.8.6.2 Rest of Europe Medical Device Regulatory Affairs Market, By Services
6.8.6.3 Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider

7. Asia Pacific Medical Device Regulatory Affairs Market: Historic and Forecast

7.1 Asia Pacific Medical Device Regulatory Affairs Market: Snapshot
7.2 Asia Pacific Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.3 Asia Pacific Medical Device Regulatory Affairs Market: Key Factors
7.4 Asia Pacific Medical Device Regulatory Affairs Market: Segment Analysis
7.5 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Type
7.5.1 Asia Pacific Medical Device Regulatory Affairs Market, By Type Overview
7.5.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
7.5.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
7.6 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Services
7.6.1 Asia Pacific Medical Device Regulatory Affairs Market, By Services Overview
7.6.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
7.6.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
7.6.4 Asia Pacific Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
7.6.5 Asia Pacific Medical Device Regulatory Affairs Market Size, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
7.7 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Service Provider
7.7.1 Asia Pacific Medical Device Regulatory Affairs Market, By Service Provider Overview
7.7.2 Asia Pacific Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
7.7.3 Asia Pacific Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)
7.8 Asia Pacific Medical Device Regulatory Affairs Market Segmentation: By Country
7.8.1 Asia Pacific Medical Device Regulatory Affairs Market, By Country Overview
7.8.2 China Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.2.1 China Medical Device Regulatory Affairs Market, By Type
7.8.2.2 China Medical Device Regulatory Affairs Market, By Services
7.8.2.3 China Medical Device Regulatory Affairs Market, By Service Provider
7.8.3 Japan Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.3.1 Japan Medical Device Regulatory Affairs Market, By Type
7.8.3.2 Japan Medical Device Regulatory Affairs Market, By Services
7.8.3.3 Japan Medical Device Regulatory Affairs Market, By Service Provider
7.8.4 India Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.4.1 India Medical Device Regulatory Affairs Market, By Type
7.8.4.2 India Medical Device Regulatory Affairs Market, By Services
7.8.4.3 India Medical Device Regulatory Affairs Market, By Service Provider
7.8.5 South Korea Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.5.1 South Korea Medical Device Regulatory Affairs Market, By Type
7.8.5.2 South Korea Medical Device Regulatory Affairs Market, By Services
7.8.5.3 South Korea Medical Device Regulatory Affairs Market, By Service Provider
7.8.6 Rest of Asia Pacific Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
7.8.6.1 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Type
7.8.6.2 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Services
7.8.6.3 Rest of Asia Pacific Medical Device Regulatory Affairs Market, By Service Provider

8. Middle East and Africa Medical Device Regulatory Affairs Market: Historic and Forecast

8.1 Middle East and Africa Medical Device Regulatory Affairs Market: Snapshot
8.2 Middle East and Africa Medical Device Regulatory Affairs Market: Market Size and CAGR, 2020-2030 (USD Million & CAGR)
8.3 Middle East and Africa Medical Device Regulatory Affairs Market: Key Factors
8.4 Middle East and Africa Medical Device Regulatory Affairs Market: Segment Analysis
8.5 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Type
8.5.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Type Overview
8.5.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Diagnostic, By Value, 2020H-2030F (USD Million & CAGR)
8.5.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Therapeutic, By Value, 2020H-2030F (USD Million & CAGR)
8.6 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Services
8.6.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Services Overview
8.6.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Regulatory Consulting, By Value, 2020H-2030F (USD Million & CAGR)
8.6.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Legal Representation, By Value, 2020H-2030F (USD Million & CAGR)
8.6.4 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Regulatory Writing & Publishing, By Value, 2020H-2030F (USD Million & CAGR)
8.6.5 Middle East and Africa Medical Device Regulatory Affairs Market, By Other Services, By Value, 2020H-2030F (USD Million & CAGR)
8.7 Middle East and Africa Medical Device Regulatory Affairs Market Segmentation: By Service Provider
8.7.1 Middle East and Africa Medical Device Regulatory Affairs Market, By Service Provider Overview
8.7.2 Middle East and Africa Medical Device Regulatory Affairs Market Size, By Outsource, By Value, 2020H-2030F (USD Million & CAGR)
8.7.3 Middle East and Africa Medical Device Regulatory Affairs Market Size, By In-house, By Value, 2020H-2030F (USD Million & CAGR)

9. Market Dynamics
9.1 Impact assessment of Market Dynamics on Global Medical Device Regulatory Affairs Market
9.2 Drivers
9.3 Restraints
9.4 Trends

10. Industry Ecosystem Analysis
10.1 Porter Analysis

11. Competitive Positioning
11.1 Companies’ Product Positioning
11.2 Market Share of Leading Companies
11.3 Company Profiling
11.3.1 ICON Plc
11.3.2 Labcorp
11.4.3 IQVIA
11.3.4 Intertek Group Plc
11.3.5 SGS SA
11.3.6 Integer Holdings Corp
11.3.7 Medpace Holdings
11.3.8 Emergo
11.3.9 Freyr Solutions
11.3.10 Promedica International

12. About Us and Disclaimer