Reading Time: 3 minutesThe Global Medical Device Regulatory Affairs Market is valued approximately USD 4.5 billion in 2020 and is anticipated to grow with a healthy growth rate of more than 8.6% over the forecast period 2021-2027. The global medical device regulatory affairs market is gaining from the changing regulatory landscape and increased need for faster approval processes. The demand for the medical device regulatory affairs is being boosted by the rise of developing industries such as diagnostics and pharmaceuticals. The global market is progressing thanks to favorable government initiatives and the increasing complexity of medical equipment. Manufacturers of medical devices are adopting ways to safeguard their products in response to increased cyber security threats and the financial implications of data breaches. When it comes to data transfer to and from the device, the government is supporting these security enhancements to address these dangers and prevent unauthorized access. Market launch and recertification timescales are becoming more challenging due to increased regulatory issues such as medical device regulation and in vitro diagnostic device regulation, as well as regulatory cyber security monitoring. Due to the increased need for businesses to address regulatory challenges, the global medical device regulatory affairs market is expanding in demand. For instance, Emergo released 510(k) Builder in February 2020, a new subscription-based software tool that simplifies and streamlines the U.S. drug approval process. The FDA’s submissions for medical device manufacturers allow for quicker market access. 510(k) Builder has comprehensive integration with FDA databases, assisting users in discovering required data such as product codes and predicate devices, as well as automating documentation formatting to FDA standards. Furthermore, expected modifications in the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Devices Regulation (IVDR) from regulators will make meeting market launch and recertification timeframes much more challenging.
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The main regions of Asia Pacific, North America, Europe, Latin America, and the Rest of the World are included in the geographical analysis of the worldwide Medical Device Regulatory Affairs Market. Currently, the Asia Pacific region is predicted to lead the global medical device regulatory affairs market. The government’s initiatives to simplify the regulatory system for foreign investigators, fast approval for innovative products, and simplified procurement restrictions are supporting the global market’s growth. Due to the presence of two main international regulatory bodies in each area, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), North America and Europe are expected to contribute considerably to the development of the global market. More than half of all medical devices are regulated by these authorities, and the US FDA publishes various guidelines for medical device producers to help with the process.
Major market player included in this report are:
Integer Holdings, ICON Plc, SGS SA, Emergo, Intertek Plc, Covance, IQVIA Holdings, Freyr, Medpace, Promedica International.
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
By Service Provider:
Furthermore, years considered for the study are as follows:
- Historical year – 2018, 2019
- Base year – 2020
- Forecast period – 2021 to 2027
Target Audience of the Global Medical Device Regulatory Affairs Market in Market Study:
Key Consulting Companies & Advisors, Large, medium-sized, and small enterprises, Venture capitalists, Value-Added Resellers (VARs), Third-party knowledge providers, Investment bankers, Investors.
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