Medical Device Regulatory Affairs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2020 - 2030

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Medical Device Regulatory Affairs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2020 - 2030

Status : July, 2021 | Medical Devices

Report Digest


Global Medical Device Regulatory Affairs Market – Overview

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.

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.

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.

The reports at TMR Research provide qualitative solutions that break the barriers of doubt or uncertainties when the stakeholders plan to expand their growth reach. The researchers compile the necessary information that enlightens the CXOs about the current growth opportunities in a specific market and enables them to make the most of the opportunities.

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5-Point Growth Formula

The 5-point growth formula developed by TMR Research provides an insight to the stakeholders and CXOs about the current situation in the market. The growth formula makes the report a perfect companion for the stakeholders and CXOs.

The 5-point growth formula includes the following points:

  • Current and Future Threats
  • Accurate Trend Analysis
  • Regional Assessment
  • Industrial Analogy
  • COVID-19 Impact

Current and Future Threats

Along with studying the opportunities necessary for growth, threats are also an important aspect to look upon for the companies and stakeholders in a specific sector. TMR Research studies every negative aspect that will hinder the growth of a specific area of business and includes it in the report. The stakeholders and CXOs will have the benefit of assessing the threat and take the necessary steps to prevent the hindrance caused due to the threats.

Accurate Trend Analysis

Keeping up with the latest trends is crucial in any business or sector. While stakeholders are aware of the trends that are on the surface, TMR Researchers find trends that are deeply entrenched in the particular market or sector. The reports are constantly updated with the latest trends so that the stakeholders and CXOs can derive benefits from the trends and generate good revenues.

Regional Assessment

Demography forms an important part of the growth pattern of all the markets. Diving deep into the demographics enables maximum output from specific areas. The TMR Research team assesses every region and picks out the vital points that have a large impact on the growth of a market.

Industrial Analogy

The analysts at TMR Research conduct an all-round analysis on the competitive landscape of the market. The observations recorded by the analysts are added to the reports so that every stakeholder gets a glimpse of the competitive scenario and frame their business plans according to the situation.

COVID-19 Impact

The COVID-19 outbreak has changed the growth projections of numerous sectors and businesses. The analysts at TMR Research have conducted a conscientious survey on the markets after the pandemic struck. The analysts have put forth their brilliant and well-researched opinions in the report. The opinions will help the stakeholders to plan their strategy accordingly.

The reports offer answers to the top 7 questions that revolve around the growth of the market

  • What are the diverse growth parameters influencing the market?
  • Which regions will contribute largely to the growth of the market
  • What are the recent innovations and technological advancements in the market?
  • What are the emerging trends across the market?
  • How has COVID-19 affected the market?
  • What will be the post-pandemic scenario of the market?
  • What are the major threats that will dent the growth prospects of the market?