Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030 –

DUBLIN–(BUSINESS WIRE)–The “Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030” report has been added to’s offering.

Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030 report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030.

In addition, we have provided the likely distribution of the opportunity across different:

  • [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories)
  • [B] device class (class I, class II and class III)
  • [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others)
  • [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world)

In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion. It is also worth noting that, since January 2018, the USFDA approved over 130 medical devices. However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators.

Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers.

According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies. In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments.

The aforementioned challenges have led many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise.

In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future.

Amongst other elements, the report includes:

  • A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).
  • A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).
  • An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
  • Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.
  • A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
  • An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.

To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry.

The report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name):

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

Key Topics Covered

1 Preface

2 Executive Summary

3 Introduction

4 Role of Regulatory Affairs in Medical Device Supply Chain

5 Regulatory and Reimbursement Landscape for Medical Devices

6 Competitive Landscape

7 Company Profiles

8 Benchmark Analysis

9 Guide to Regulatory Outsourcing Models

10 Medical Device Developer and CRO Relationships: Key Value Drivers and Performance Indicators

11 Market Forecast

12 Conclusion

13 Survey Insights

14 Executive Insights

15 Appendix I: Tabulated Data

16 Appendix II: List of Companies and Organizations

  • 1MED SA
  • 4Clinics
  • A+ Science
  • Abbott
  • Accell Clinical Research
  • Accredited Consultants
  • Accutest Global
  • Acorn Regulatory Consultancy Services
  • Acrapack
  • acromion
  • aCROss Medical
  • Activa Cro
  • Actolis
  • ADAX International
  • Advanced Medical Research (AMR)
  • Advena
  • AE Performance Testing Lab
  • Affinity Bio Partners
  • Afra Pharma Consultant
  • AG Mednet
  • Aginko Research
  • Al Tamimi
  • Allied Clinical Management
  • Allscripts Healthcare Solutions
  • Alquest
  • Amarex
  • American Preclinical Services
  • AmeRuss
  • Amritt
  • analyze & realize
  • Andaman Medical
  • Anteris Medical
  • A-pharmaconsult
  • apices
  • APO Plus Station
  • Appletree CI Group
  • Arazy Group Consultants
  • ARC Pharma
  • Archemin
  • Arlenda
  • ARQon
  • Asia Actual
  • AtoZ-CRO
  • Australian Healthcare Solutions
  • and over 400 more…

For more information about this report visit


Laura Wood, Senior Press Manager

[email protected]
For E.S.T. Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

error: Content is protected !!