The contract regulatory affairs-management services market for medical devices is estimated
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
By: Roots Analysis
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.
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;
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%).
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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:
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