Medical Device Regulatory Affairs Market By Services (Regulatory consulting /Strategic Services, Regulatory writing and publishing, Legal representation, Product Registration and Clinical trials, Others), By Service Provider (In-House, Out sourcing), By T

Medical Device Regulatory Affairs Market By Services (Regulatory consulting /Strategic Services, Regulatory writing and publishing, Legal representation, Product Registration and Clinical trials, Others), By Service Provider (In-House, Out sourcing), By Types (Diagnostic, Therapeutics), By Indication (Infectious Diseases, Oncology and Hematology, Gynaecology and Obstetrics, Muscusloskeletal Disorders, Respiratory, Cardiovascular, Others): Global Opportunity Analysis and Industry Forecast, 2021-2031

The global Medical Device Regulatory Affairs Market was valued at $6,969.7 million in 2021, and is projected to reach $12,247.7 million by 2031, registering a CAGR of 5.8% from 2022 to 2031.

Medical Device Regulatory Affairs are Regulatory affairs (RA), commonly known as government affairs, is a specialty in regulated industries such as pharmaceuticals, medical devices, and agrochemicals. Within the healthcare industry, regulatory affairs have a very specific connotation. The regulatory function in the healthcare industry is critical in ensuring the availability of safe and effective healthcare products around the world. Regulatory professionals include individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary job function is clinical affairs or quality assurance. Medical Device Regulatory Affairs experts serve as a link between the medical device industry and regulatory bodies around the world, including the United States, the United Kingdom, Canada, the European Union, India, Japan, and Australia. As one of the most highly regulated industries, the healthcare industry needs more experts than ever before who are capable of resolving regulatory issues in a proficient way. Regulatory affairs experts are critical in ensuring that all medical devices comply with industry regulations. Industry regulatory specialists are involved with a wide range of medical devices manufactured in various nations. As regulatory processes become more sophisticated and broader, and as the area becomes more globalized, there will be a continued demand for personnel with a strong background in medical device regulatory affairs. 

The advantages of medical device regulatory affairs are that it ensure that all GCP and ICH guidelines, as well as EU CTD and other applicable laws and regulations, are followed when conducting clinical trials for medical devices, it help in establishing, maintaining, and obtaining senior management approval for the Quality Management project and strategic audit programmed and also it help in setting up and maintaining clinical quality assurance papers, protocol deviations, investigations, and change management systems and tools wherever required for the approval of new medical device. With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs across different geographies. For Medical Devices, the Quality and Regulatory affairs requirements kick in and play a crucial role from the product design phase and provide guidelines across the product lifecycle.

The market is expected to witness a moderate growth during the forecast period, owing to rise in adoption and development of advanced medical devices for the treatment of various disease such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increasing applications in the healthcare sector. Furthermore, surge in geriatric population along with various technological advancements in the market to meet the unmet needs of patients provides significant opportunities for existing players and new entrants. 

However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks & concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.

Impact of COVID-19 pandemic is expected to remain negative for the medical device regulatory affairs market, as the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty. 

For instance, the impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology. IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances. Clinical trial protocols are required to be changed to eliminate apparent immediate hazards to participants such as changing in-person visits to virtual visits, elimination of study visits/procedures that do not impact the integrity of the study or participant safety, incorporation of screening questions to identify potential COVID-19 exposure.

The global medical device regulatory affairs market is segmented on the basis of services, service provider, types, indication and region. On the basis of services, the market is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials and others. By service provider, it is classified into in-house and out-sourcing. By types it includes diagnostics and therapeutics. By indication the segment includes infectious diseases oncology & hematology, gynecology & obstetrics, musculoskeletal disorders, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Some of the key players operating in the global medical device regulatory affairs market include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon PLC, IQVIA, NKG, Parexel and Pepgra.

Key Benefits For Stakeholders


This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device regulatory affairs market analysis from 2021 to 2031 to identify the prevailing medical device regulatory affairs market opportunity.

The market research is offered along with information related to key drivers, restraints, and opportunities.

Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.

In-depth analysis of the medical device regulatory affairs market segmentation assists to determine the prevailing market opportunities.

Major countries in each region are mapped according to their revenue contribution to the global market.

Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.

The report includes the analysis of the regional as well as global medical device regulatory affairs market trends, key players, market segments, application areas, and medical device regulatory affairs market growth strategies.

Key Market Segments


By Services

Regulatory consulting /Strategic Services
Regulatory writing and publishing
Legal representation
Product Registration and Clinical trials
Others

By Service Provider

In-House
Out sourcing

By Types

Diagnostic
Therapeutics

By Indication

Infectious Diseases
Oncology and Hematology
Gynaecology and Obstetrics
Muscusloskeletal Disorders
Respiratory
Cardiovascular
Others

By Region

North America
U.S.
Canada
Mexico
Europe
Germany
France
United Kingdom
Italy
Spain
Rest of Europe
Asia-Pacific
Japan
China
India
South Korea
Malaysia
Rest of Asia-Pacific
LAMEA
Brazil
Israel
Saudi Arabia
South Africa
Rest of LAMEA

Key Market Players

Amerisource Bergen
Charles river
Clini expert
Emergo
icbio cro
icon plc
IQVIA Holdings Inc.
NKG
parexel
Pepgra