Medical Device Regulatory Affairs Market Worth $8.6 Billion By 2028

May 2021 | Report Format: Electronic (PDF)

Medical Device Regulatory Affairs Market Growth & Trends

The global medical device regulatory affairs market size is expected to reach USD 8.6 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 8.6% from 2021 to 2028. Technological advancements in medical devices such as AI/Machine learning, increasing trends of portable and smaller devices, and government regulations are driving the market.

Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become an essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.

Also, due to COVID-19, the global regulatory landscape is changing for all medical device companies. Exemptions have been granted by countries ranging from China to Australia and beyond. China has intensified the registration of medical protective clothing. Respirators, protective gear, thermometers, and surgical masks are exempt from registration requirements in Singapore. Australia exempts diagnostic, confirmatory testing, prevention, monitoring, and treatment devices. With these leverages, companies might be able to enter the market easily and start selling their equipment. This, in turn, can ease the burden on the regulatory affairs team.


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Medical Device Regulatory Affairs Market Report Highlights

  • The regulatory writing and publishing segment dominated the market with the largest revenue share of 36.4% in 2020. This is due to a rise in the number of clinical trials, government support, and increasing need to launch the product quickly

  • Based on type, the therapeutic segment accounted for the larger market share of 55.3% in 2020, due to increasing demand for equipment as a result of technological advancements in developed countries

  • There is a huge demand for outsourcing of these services. Hence, the segment contributed to 60% of the global market. This is largely owing to the lack of in-house capabilities and ever-changing regulations for medical devices across the globe

  • The Asia Pacific dominated the market and accounted for 37.1% of the revenue share in 2020. This is largely due to the expanding medical device market in India as a result of increased health awareness, a growing middle class, and government health initiatives

Medical Device Regulatory Affairs Market Segmentation

Grand View Research has segmented the global medical device regulatory affairs market based on services, type, service provider, and region:

Medical Device Regulatory Affairs Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

Medical Device Regulatory Affairs Type Outlook (Revenue, USD Million, 2016 - 2028)

  • Diagnostics

  • Therapeutics

Medical Device Regulatory Affairs Service Provider Outlook (Revenue, USD Million, 2016 - 2028)

  • Outsource

  • In-house

Medical Device Regulatory Affairs Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

List of Key Players of Medical Device Regulatory Affairs Market

  • ICON Plc

  • Emergo

  • Covance

  • Freyr

  • Promedica International

  • Medpace

  • IQVIA Holdings

  • Intertek Plc

  • SGS SA

  • Integer Holdings

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