Medical Device Regulatory Affairs Outsourcing Market to reach USD 17.12 billion by 2031

Medical device regulatory affairs outsourcing involves hiring external experts or firms to handle regulatory compliance tasks such as submissions, documentation, and compliance strategies for medical devices. This allows companies to navigate complex regulations efficiently, ensure compliance, and focus on core business activities while leveraging specialized expertise.      

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The medical device regulatory affairs outsourcing market is thriving, as highlighted by a Global Observatory on Health R&D analysis in February 2022. This growth aligns with the escalating recruitment of trials registered on the WHO ICTRP worldwide, reflecting a steadfast global dedication to advancing healthcare research and development, underpinning market expansion.                                

Data Bridge Market Research analyses that the global medical device regulatory affairs outsourcing market, which was USD 6.53 billion in 2023, is expected to reach USD 17.12 billion by 2031, and is expected to undergo a CAGR of 12.8% during the forecast period of 2024 to 2031. This indicates that the market value. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Some of the major players operating in the global medical device regulatory affairs outsourcing market are:

Parexel International (MA) Corporation. (U.S.)

 North American Science Associates, LLC U.S.)

SGS Société Générale de Surveillance SA. (Switzerland)

Pace (U.S.)

 Trilogy Writing & Consulting GmbH (Germany)

 Creganna (Ireland)

 Intertek Group plc (U.K.)

WuXi AppTec (China)

 Charles River Laboratories (U.S.)

 Celestica Inc. (Canada)

 Freyr (U.S.)

 Cactus Communications (India)

 In.Corp Indonesia (Indonesia)

 Eurofins Scientific (Luxembourg)

 Plexus Corp. (U.S.)

 Sanmina Corporation (U.S.)

 OMRON Corporation (Japan)

Opportunities

Mergers and Acquisitions for Better Efficiency

Mergers and acquisitions in the medical device sector necessitate regulatory harmonization and product portfolio integration. This fuels demand for outsourced regulatory expertise to navigate transitional phases efficiently, ensuring compliance and accelerating time-to-market for newly consolidated entities.

Drivers

Changing Healthcare Landscape to Ensure Adaptability

The evolving healthcare landscape, including policy shifts, reimbursement criteria adjustments, and heightened patient safety concerns, constantly reshapes regulatory requirements. This dynamic environment underscores the ongoing need for regulatory support to ensure compliance and adaptability within the medical device industry, driving demand for specialized expertise and regulatory affairs outsourcing services.

Global Medical Device Regulatory Affairs Outsourcing Market Scope

The global medical device regulatory affairs outsourcing market is segmented on the basis of services, product, device type, category, application and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Services

Regulatory Affairs Services

Quality Consulting

Regulatory Writing and Publishing

Regulatory Submissions

Clinical Trial Applications

Product Registrations

Legal Representation

Medical Writing

 Product

Finished Goods

Electronics

Raw Material

 Device Type

Class I

Class II

Class III

 Category

Biologics

Drugs

Medical Devices

 Application

Cardiology

Diagnostic Imaging

Orthopedic

IVD

Ophthalmic

General and Plastic Surgery

Drug Delivery

Dental

Endoscopy

Diabetes Care

Others

 End User

Small Medical Device Company

Medium Medical Device Company

Pharmaceutical and Biotechnology Companies

Medical Devices Manufacturer

Large Medical Device Company

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