Medical Device Testing and Certification Market, By Service Type (Testing Services, Inspection Services, and Certification Services), By Sourcing Type (In-house and Outsourced), By Device Class (Class I, Class II, and Class III), By Technology (Active Implant Medical Device, Active Medical Device, Non-Active Medical Device, In-Vitro Diagnostic Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Other Technologies), and By Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Published In : Apr 2023

Code : CMI5665

Pages :172

Formats :

Excel and PDF

Industry : Medical Devices

Market Challenges And Opportunities

Global Medical Device Testing and Certification Market Drivers:

Rise in focus on medical device testing to augment market growth

One of the key factors expected to augment the growth of the global medical device testing and certification market during the forecast period is the rise in focus on the medical device testing and certification. For instance, in January 2022, TÜV SÜD planned to expand its Medical and Health Services (MHS) facilities in New Brighton, Minnesota. A new laboratory will offer an end-to-end testing solution for all medical devices and will provide a range of biological and chemical testing of medical devices that complements TÜV’s current active medical device testing capabilities.

Strict government regulations to underpin market growth

Another factor which is driving the growth of the global medical device testing and certification market is the strict government regulations around the world. For instance, the standard guidelines of medical devices vary from country to country, and it is mandatory for manufacturers to follow these guidelines for marketing or selling of their medical products in the country. For instance, the U.S. follows the Food and Drug Administration (FDA) guidelines, Europe considers Conformitè Europëenne (CE) approval, Canada needs the Health Canada Registration, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).

Global Medical Device Testing and Certification Market Opportunities:

The outbreak of COVID-19 is expected to provide significant growth opportunities for players in the global medical device testing and certification market. For instance, the outbreak of COVID-19 increased demand for medical device testing and certification services worldwide. In 2020, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for medical devices to diagnose COVID-19 as well as Personal Protective Equipment (PPE) needed to protect both healthcare providers and patients. The medical testing and certification continues and has taken a fast phase during the COVID 19 situation.

Increase in use of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices is expected to offer significant growth opportunities for players in the global medical device testing and certification market. For instance, deployment of advanced technologies, such as AI and IoT, along with a focus on real-time patient monitoring, have created a complex ecosystem for medical devices. To receive a marketing authorization, these devices must undergo methodical testing and need to comply with stringent regulations. Hence, market players or manufacturers are investing heavily to test their devices and receive a marketing authorization.

Restraints & Challenges:

Diversity in regulations
Outbreak of COVID-19

Diversity in regulations to hinder growth of the market

One of the key factors expected to hamper the growth of the global medical device testing and certification market is the diversity in regulations or stringent rules and regulations. The standard guidelines of medical device vary from country to country; which is mandatory for manufacturers to follow, for marketing or selling their products in the country. Regulations are different in every country. Therefore, for medical device manufacturers, it is very crucial to register and/or receive the regulatory guidelines of that specific country.

The outbreak of COVID-19 to hamper market growth

Another factor which is hampering the growth of the global medical device testing and certification market is the outbreak of COVID-19. The pandemic has increased the demand for medical device testing and certification services. Though there are exemption and leverages in the regulations, the medical testing/certification continues and has taken a fast phase during the pandemic. However, the pandemic had a slight impact on the market as the testing of other medical devices, which are not an emergent, were put on hold.