Medical Device Regulatory Affairs Market | Exclusive Report on the Latest Development and Growth Opportunities in the Market

The shifting regulatory landscape and growing demand for quicker approval processes are positively influencing the progress of the global medical device regulatory affairs market. The expansion of emerging fields such as diagnostics and therapeutics is further propelling the demand for the global medical device regulatory affairs market.

Favorable government initiatives and the growing complexity of medical devices are facilitating the advancement of the global market. The rising cybersecurity threats and the financial impact of data breaches are making manufacturers of medical devices adopt strategies to safeguard their products. The government is supporting these security improvements to address these risks and prevent unauthorized access when it comes to data transfer to and from the device.

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Global Medical Device Regulatory Affairs Market – Notable Developments

The global medical device regulatory affairs market features a competitive landscape and the key players are focusing on geographic expansion and launch of new services, partnerships, mergers and acquisitions. Several companies are also strengthening their product portfolio and manufacturing capacities enabling them to gain a competitive advantage in the global market.

Some of the leading companies in the global medical device regulatory affairs market include names such as Integer Holdings, ICON Plc, SGS SA, Emergo, Intertek Plc, Covance, IQVIA Holdings, Freyr, Medpace, and Promedica International among others. Some of the notable developments in the global medical device regulatory affairs market are given below:

  • In February 2020, Emergo has released 510(k) Builder, which is a new subscription-based software tool capable of simplifying and streamlining the U.S. FDA’s submissions for the manufacturers of medical devices enabling faster access to the market. 510(k) Builder contains full integration with FDA databases and aids its users in identifying required data such as product codes and predicate devices, as well as automated formatting of documentation as per FDA requirements.

Global Medical Device Regulatory Affairs Market – Drivers and Restraints

Several new regulatory challenges such as medical device regulation and in vitro diagnostic device regulation along with the regulatory cybersecurity scrutiny are making the market launch and recertification timelines difficult. The demand for the global medical device regulatory affairs market is increasing due to the growing requirements for businesses to manage regulatory hurdles.

The prevalence of a variety of chronic diseases such as cardiovascular diseases, respiratory disorders, diabetes, and cancer are propelling the requirement for advanced therapeutic products. The treatment of multiple modalities involves the usage of a combination product and more than one regulatory agency office reviews the submission. The complexity of combination products makes it difficult to understand the regulatory requirements applicable to them, generating further demand for the global medical device regulatory affairs market.

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Global Medical Device Regulatory Affairs Market – Geographical Outlook

The medical device regulatory market has five main regions that provide the reader with the intricate details of the working dynamics of the regional landscape. These regions are North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. Of these, currently, the global medical device regulatory affairs market is expected to be led by the regional segment of Asia Pacific.  The government efforts for simplification of the regulatory system for foreign investigators, accelerated approval for innovative products, and procurement control relaxation are bolstering the progress of the global market.

North America and Europe are also expected to be contributing significantly to the development of the global market due to the presence of two major international regulatory agencies- the U.S. FDA and the European Medicines Agency (EMA) in the respective regions. These agencies regulate more than half of medical devices worldwide and the U.S. FDA issues various guidelines for medical device manufacturers to aid the process.

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