Global Medical Device Testing and Certification Market Size

Medical Device Testing Market Analysis

The Global Medical Device Testing and Certification Market size is estimated at USD 10.57 billion in 2024, and is expected to reach USD 12.73 billion by 2029, growing at a CAGR of 3.80% during the forecast period (2024-2029).

During the COVID-19 outbreak in 2020, several measures were taken to prevent the transmission of diseases, such as lockdown measurements and restricting import-export activities between the countries, which disrupted the supply chain, thus, negatively impacting the overall market studied.

Moreover, the disruption caused due to COVID-19 in international supply chains has led to shortages of critical medical devices across the world. Therefore, many countries have taken definite measures to ease the shortages by importing equipment, such as domestic manufacturing of medical devices. Additionally, domestic manufacturing of essential medical devices is expected overcome trade barriers, at the same time, ensure product quality and market stability.

As per British Standards Institution (BSI), in February 2020, by taking into consideration the effects of the COVID-19 pandemic, the company reviewed processes and planned a program to minimize the risk to British Standards Institution (BSI) clients and colleagues while maintaining accreditation requirements and mitigating potential global trade risks.

The medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices. Therefore, it is compulsory for every device to comply with national and international standards before entering a market. The standard guidelines of medical devices vary from country to country, and it is mandatory for every manufacturer to follow these guidelines for marketing or selling their products in a country. For instance, the United States follows Food and Drug Administration (FDA) guidelines, Europe considers Conformitè Europëenne (CE) approval, Canada needs Health Canada Registration, and India requires approval from Central Drugs Standard Control Organisation (CDSCO). This diverse range of regulatory landscapes drives the testing and certification market.

Since regulations are different in every country, it is crucial for each medical device manufacturer to register or receive regulatory guidelines of that specific country, which, in turn, indicates the need for authorized third parties to register their devices. National regulatory authorities of every country prefer that the manufacturers selling their products in that particular country should comply with standard guidelines and get it checked by a third-party certification system.

This may result in propelling the testing and certification market, as well as increase easy market access. The other factors, such as the increasing need for validation and verification (V&V) for medical devices, are driving the medical device testing and certification market. However, a factor such as diversity in regulation is expected to impede market growth over the forecast period.