Medical Device Regulatory Affairs Market Top Manufacturer Analysis and Forecast to 2028

 Medical Device Regulatory Affairs Industry Overview

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.

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:

Based on the Services Insights, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications and Other Services.

  • The regulatory writing and publishing segment dominated the market for medical device regulatory affairs with 36.4% of revenue share in 2020. 
  • The segment of product registration and clinical trial services is anticipated to witness the fastest growth rate of 25.1% over the forecast period. 

Based on the Type Insights, the market is segmented into Diagnostics and Therapeutics.

  • The therapeutics segment led the market for medical device regulatory affairs and accounted for the largest revenue share of more than 55.0% in 2020. The segment is also projected to witness the fastest CAGR of 8.9% during the forecast period. 

Based on the Service Provider Insights, the market is segmented into Outsource and In-house.

  • The outsourcing segment dominated the market for medical device regulatory affairs with the largest revenue share of 60.0% in 2020. This is largely attributed to the lack of an in-house regulatory team.

Medical Device Regulatory Affairs Regional Outlook

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa (MEA)

Key Companies Profile

Market players are undertaking various strategic initiatives such as the launch of new services partnerships, collaborations, mergers and acquisitions, geographic expansion, aiming to strengthen their product portfolio, manufacturing capacities, and provide a competitive advantage.

Some prominent players in the global Medical Device Regulatory Affairs market include

  • ICON Plc
  • Emergo
  • Covance
  • Freyr
  • Promedica International
  • Medpace
  • IQVIA Holdings
  • Intertek Plc
  • SGS SA
  • Integer Holdings

Order a free sample PDF of the Medical Device Regulatory Affairs Market Intelligence Study, published by Grand View Research.

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