The contract regulatory affairs-management services market for medical devices is estimated to be worth USD 820 million by 2030, growing at a CAGR of 6.9%, claims Roots Analysis

Published: March 2020

In order to reduce risk of device recalls and expedite time to market, medical device developers rely on contract service providers for regulatory submissions and navigating various challenging aspects of the product review and approval process 

Roots Analysis has announced the addition of Regulatory Affairs Management for Medical Devices Market report to its list of offerings. 

More than 130 medical devices were approved by the FDA since January 2018, while several are currently being evaluated across more than 9,500 (active) clinical trials, worldwide. Even though technical innovation has enabled the development of a variety of versatile medical devices, product approval, given stringent regulatory standards, is still a concern. 

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Key Market Insights 

Over 400 CROs claim to offer regulatory affairs-management services for medical devices
Of these, over 40% players provide the aforementioned services for all device classes. Further, the market is characterized by the presence of companies of all sizes; it is also worth noting that very small and small companies are solely comprised of more than 50% of the competitive landscape.

About 30% of companies have elaborate service portfolios, offering end-to-end solutions 
Most players (78%) offer assistance in regulatory document submissions; other popular services (in terms of number of companies offering them) include vigilance and medical device reporting (74%), followed by technical dossier set-up (72%), product registration and clinical trial applications (67%), risk management-related services (65%), and regulatory writing and publishing (59%).

60% CROs offer support for launching medical devices in developed regions 
Majority of the service providers are experienced in enabling their sponsors to have their products launched in the US and are capable of efficiently navigating the regulatory framework established by the US FDA. Regarding developing regions, many CROs presently claim to be familiar with the regulatory environments in China (18%), Australia (16%) and India (13%).

Quality and reliability are considered to be important parameters while selecting a CRO 
Nearly 75% big pharma players stated that the aforementioned parameters were crucial for evaluating the performance of a potential contract services partner. Other important performance metrics that emerged in this assessment include flexibility, financial stability, and cost and time management. 

North America and Europe are anticipated to capture over 65% the market share by 2030
In addition, the market in the Asia-Pacific is projected to grow at a relatively faster rate (~24%). Further, in terms of device class, class II medical devices currently represent the highest share (48%); this trend is unlikely to change in the foreseen future.

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Key Questions Answered

  • Who are the leading CROs offering regulatory affairs-management services for medical devices?
  • What are differences in regulatory guidelines for medical device approval, across various geographies? 
  • What are the key performance indicators used by sponsors to evaluate potential service providers?
  • What are the popular outsourcing models used by medical device companies for regulatory affairs-management purposes?
  • What are the key challenges faced by medical device developers / manufacturers in terms of regulations related to medical device approvals?
  • How is the current and future market opportunity likely to be distributed across key market segments?

The USD 820 million (by 2030) financial opportunity within the contract regulatory affairs-management services market for medical devices has been analyzed across the following segments:

  • Medical Device Class
    • Class I
    • Class II
    • Class III
  • Therapeutic Area 
    • Cardiovascular Disorders 
    • CNS Disorders
    • Metabolic Disorders
    • Oncological Disorders
    • Ophthalmological Disease
    • Orthopedic Disorders
    • Pain Disorders 
    • Respiratory Disorders
    • Others
  • Type of Regulatory Affairs Service 
    • Pharmacies GAP-Analysis
    • Pharmacies Legal Representation
    • Pharmacies Notified Body Selection
    • Product Labelling-related Services
    • Product Registration and Clinical Trial Applications
    • Regulatory Document Submissions
    • Regulatory Writing and Publishing
    • Risk Management-related Services
    • Technical Dossier Set-up
    • Vigilance & Medical Device Report
  • Key Geographical Regions 
    • North America
    • Europe
    • Asia-Pacific and Rest of the World

The report features inputs from eminent industry stakeholders, according to whom, presently, regulatory affairs management, clinical trial site selection, trial monitoring and project management are the activities outsourced by most of the sponsor companies. Further, the requirement for highly experienced personnel for conducting such activities has compelled developers to outsource their regulatory affairs management operations, since most of the players are inherently inexperienced in navigating through the complex regulatory frameworks. The report includes detailed transcripts of discussions held with the following experts:

  • Troy McCall (Chief Operating Officer, CROMSOURCE)
  • Antal Solyom (Director, Medical Device Unit, HungaroTrial)
  • C Omprakash (Technical Director and Partner, Vyomus Consulting) 
  • Nazish Urooj (Senior Manager, Medical & Clinical Operations, Metrics Research)
  • Christian Wolflehner (General Manager, CW Research & Management)
  • Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)
  • Tania Persson (Business Development Manager, A+ Science)

The research covers detailed profiles, featuring an overview of the company, its financial information (if available), regulatory affairs-based service portfolio, recent developments and an informed future outlook. 

  • CTI Clinical Trial and Consulting Services
  • ICON
  • Intertek
  • Medpace
  • MIC Medical
  • North American Science Associates (NAMSA)
  • Parexel
  • PharmaLex
  • Premier Research 
  • Société Générale de Surveillance (SGS)
  • Underwriters Laboratory (UL)

For additional details, please email at

Gaurav Chaudhary
+1 (415) 800 3415


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