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

BULLHEAD CITY, Ariz. - April 2, 2020 - PRLog -- 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%).

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.

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Gaurav Chaudhary
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Gaurav.Chaudhary@rootsanalysis.com (mailto:Gaurav.Chaudhary@rootsanalysis.com?subject=Contract%20Regulatory%20Affairs-Management%20Market%20for%20Medical%20Devices%2C%202019-2030%20-%20Press%20Release%20Query)