MEDICAL DEVICE TESTING AND CERTIFICATION MARKET ANALYSIS

Regional Analysis

Global Medical Device Testing and Certification Market: Regional Insights

Based on geography, the global medical device testing and certification market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period due to the stringent government regulations, the outbreak of COVID-19, and rising demand for verification and validation of medical devices. For instance, the Food and Drug Administration (FDA) is responsible for regulating medical devices in the United States. FDA regulates medical devices to assure their safety and effectiveness and develops, and carries out the national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products.

Europe and Asia Pacific are also expected to witness robust growth in the global medical device testing and certification market due to the outbreak of COVID-19, increase in focus on the quality of the medical devices, and strict government regulations in these regions. For instance, competent authorities, notified bodies, and authorized representatives are all involved in CE marking process. Medical devices are regulated at the EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Manufacturers can place the CE mark on a medical device once it has passed a conformity assessment.

• North America: U.S. and Canada
• Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
• Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
• Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
• Middle East and Africa: GCC Countries, Israel, Rest of Middle East, South Africa, North Africa, and Central Africa