Allied Market Research


Medical Devices Regulatory Affairs Market

Medical Devices Regulatory Affairs Market Size, Share, Competitive Landscape and Trend Analysis Report by Service Provider, by Service Type, by Indication and by Product Stage : Global Opportunity Analysis and Industry Forecast, 2023-2032

LS : Medical Devices & Supplies

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Author's: | Roshan Deshmukh
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Medical devices sector plays important role in healthcare industry by providing innovative devices that improve patient outcomes. Each company in medical devices sector seeks to innovate, whether through recent updates for existing technology or by developing new devices that could offer more effective treatment. Regulatory affairs serve important function throughout a medical device product life cycle such as leading premarket strategy, drafting regulatory submissions, and ensuring post-market compliance. Most countries all over the world have their own medical devices regulation. However, global regulatory affairs are always changing, so successful regulatory affair team follows global trends and regulatory affair service provider are always aware of new regulation programs.

COVID-19 Impact Analysis             

COVID-19 is an infectious disease that originated in Hubei province of the Wuhan city in China in late December. The highly contagious disease, caused by a virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is transmitted from human to human. Since the outbreak in December 2019, the disease has spread to almost 213 countries around the globe with the World Health Organization declaring it a public health emergency on March 11, 2020.

There has been an increase in the demand for medical supplies to take care of infected population. Respiratory support devices such as atomizers, life-support machines, oxygen generators, and monitors are among the majorly used medical devices in primary clinical treatment. Moreover, COVID-19 has led to a huge surge in demand for medical supplies such as personal protective equipment including masks, gloves, and protective eyeglasses. There is an increase in the need for medical supplies, both from healthcare professionals and civil population for precautionary measures, owing to the rise in number of COVID-19 cases worldwide. Manufacturers of these products have a chance to capitalize this increased demand for medical supplies to ensure adequate and continuous supply of personal protective equipment in the market. Therefore, COVID-19 is expected to have a significant impact on the medical devices regulatory affairs market.

Top Impacting Factors

  • Rise in demand of technical experts, surge in launch of innovative products, grow in evolution of regulatory guidelines, increase in requirement of technologically advanced medical devices, and well established companies are expected to drive the growth of the market.
  • In addition, rise in technological advancement in health care sector, strict guidelines for approval of new products, rise in challenges faced by medical device companies related documentation, R & D activities to launch innovative medical devices, grow in need for proper authority guidelines managers, and collaboration & merger between key market players with local players to cope up with changing guidelines are the key factors that drive the growth of the market.
  • However, rise in efforts for preparation of technical documents and surge in cost of legal advices can restrain the growth of the market.
  • Contrarily, expected rise in launch of novel medical devices are expected to offer lucrative opportunities for the expansion of the market.

Market Trends

New Product Launches to Flourish the Market

In 2021, Taiwan government announced launch of new medical device regulation and they were effective from 1 may 2021.

In 2019, WuXi AppTech announced takeover of Pharmapace that offer biometric services for regulatory submissions, phase trials and post-marketing support.

In 2018, Medical Health Regulatory AgencyMHRA which is a regulatory agency announced launch of new one-stop online services for medical devices firms. Customers can submit medical devices information online and can track progress of their application.

Key Benefits of the Report

  • This study presents the analytical depiction of medical devices regulatory affairs market industry along with the current trends and future estimations to determine the imminent investment pockets.
  • The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the market share.
  • The current market is quantitatively analyzed to highlight the market growth scenario.
  • Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
  • The report provides a detailed market analysis depending on competitive intensity and how the competition will take shape in coming years.

Questions Answered in the Medical Devices Regulatory Affairs Market Report

  • Which are the leading players active in the medical devices regulatory affairs market?
  • What are the current trends that will influence the market in the next few years?
  • What are the driving factors, restraints, and opportunities of the market?
  • What future projections would help in taking further strategic steps?
  • What is "medical devices regulatory affairs"?
  • What is "medical devices regulatory affairs" market prediction in the future?
  • Who are the leading global players in the "medical devices regulatory affairs" market?
  • What are the current trends and predicted trends?
  • What are the key benefits of the "medical devices regulatory affairs" market report?

Medical Devices Regulatory Affairs Market Report Highlights

Aspects Details
By Service Provider
  • In-House
  • Outsourcing
By Service Type
  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product Registration & Clinical Trial Application
  • Others
By Indication
  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others
By Product Stage
  • Preclinical Trials
  • Clinical Trials
  • Post Market Trials
By Region
  • North America  (U.S., Canada, Mexico)
  • Europe  (France, Germany, Italy, Spain, UK, Rest of Europe)
  • Asia-Pacific  (China, Japan, India, South Korea, Australia, Rest of Asia-Pacific)
  • LAMEA  (Brazil, South Africa, Saudi Arabia, Rest of LAMEA)
Key Market Players

Freyr, PRA Health Sciences, Accell Clinical Research, LLC., WuXi AppTec Inc., Charles River Laboratories International, Inc., Parexel International Corporation, Promedica International, Icon plc, Medpace, GenPact Ltd., Criterium, Inc.

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Medical Devices Regulatory Affairs Market

Global Opportunity Analysis and Industry Forecast, 2023-2032