PUBLISHER: Azoth Analytics | PRODUCT CODE: 1473852
PUBLISHER: Azoth Analytics | PRODUCT CODE: 1473852
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:
Table of Content
List of Tables
Table A1: Global Impact of Macro Economic Factors, By Region
Table A2: Recall Status of Medical Device Recalls from 2018 to 2022
Table A3: United States Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A4: United States Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A5: United States Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A6: United States Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A7: United States Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A8: United States Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A9: Canada Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A10: Canada Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A11: Canada Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A12: Canada Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A13: Canada Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A14: Canada Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A15: Rest of Americas Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A16: Rest of Americas Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A17: Rest of Americas Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A18: Rest of Americas Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A19: Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A20: Rest of Americas Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A21: United Kingdom Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A22: United Kingdom Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A23: United Kingdom Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A24: United Kingdom Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A25: United Kingdom Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A26: United Kingdom Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A27: Germany Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A28: Germany Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A29: Germany Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A30: Germany Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A31: Germany Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A32: Germany Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A33: France Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A34: France Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A35: France Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A36: France Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A37: France Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A38: France Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A39: Italy Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A40: Italy Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A41: Italy Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A42: Italy Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A43: Italy Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A44: Italy Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A45: Rest of Europe Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A46: Rest of Europe Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A47: Rest of Europe Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A48: Rest of Europe Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A49: Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A50: Rest of Europe Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A51: China Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A52: China Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A53: China Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A54: China Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A55: China Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A56: China Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A57: Japan Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A58: Japan Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A59: Japan Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A60: Japan Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A61: Japan Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A62: Japan Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A63: India Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A64: India Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A65: India Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A66: India Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A67: India Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A68: India Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A69: South Korea Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A70: South Korea Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A71: South Korea Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A72: South Korea Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A73: South Korea Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A74: South Korea Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A75: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Type, By Value, 2020-2023 (USD Million)
Table A76: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Type, By Value, 2024-2030 (USD Million)
Table A77: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Services, By Value, 2020-2023 (USD Million)
Table A78: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Services, By Value, 2024-2030 (USD Million)
Table A79: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2020-2023 (USD Million)
Table A80: Rest of Asia-Pacific Medical Device Regulatory Affairs Market, By Service Provider, By Value, 2024-2030 (USD Million)
Table A81: ICON Key Company Financials, 2021-2023
Table A82: Labcorp Key Company Financials, 2021-2023
Table A83: IQVIA Key Company Financials, 2021-2023
Table A84: Intertek Key Company Financials, 2021-2023
Table A85: SGS Key Company Financials, 2021-2023
Table A86: Integer Key Company Financials, 2021-2023
Table A87: Medpace Key Company Financials, 2021-2023