India Medical Device Testing and Certification Market Size Booming to Touch USD 2.4 Billion by 2029

Published | 03 October 2023

India medical device testing and certification market is flourishing due to the rising demand for medical device verification and validation, a growing number of small medical device companies lacking in-house expertise, and increasingly stringent government regulations.

BlueWeave Consulting, a leading strategic consulting and business research firm, in its recent study, estimated that the India medical device testing and certification market size at USD 1,674.9 million in 2022. During the forecast period between 2023 and 2029, BlueWeave expects the India medical device testing and certification market size to grow at a CAGR of 5.2% reaching a value of USD 2,388.4 million by 2029. Rising demand for medical device verification and validation, a growing number of small medical device companies lacking in-house expertise, and increasingly stringent government regulations are key drivers propelling the India medical device testing and certification market during the period in analysis.

Opportunity: Government’s initiatives promoting domestic manufacturing and supporting medical device companies

Government initiatives, such as the "Make in India" campaign, actively promote the growth of domestic medical device manufacturing. This results in an increased production of medical devices that require rigorous testing and certification to meet quality and safety standards. Government regulations are becoming increasingly stringent to ensure the safety and effectiveness of medical devices. Manufacturers must comply with these regulations, leading to a higher demand for testing and certification services to meet regulatory requirements. Government incentives, subsidies, and grants provide financial support to medical device companies. This financial assistance helps manufacturers invest in testing and certification processes, which are often costly but essential for compliance.

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Class 1 segment holds the largest market share by device class

Based on device class, the class 1 segment is expected to grow in the forecast period. India's healthcare sector is expanding, with increasing healthcare infrastructure and facilities. This growth leads to greater demand for a wide range of medical devices, including Class 1 devices. Class 1 devices encompass a broad range of products, from simple bandages to handheld surgical instruments. The diversity of healthcare needs and applications drives the demand for these devices. While Class 1 devices are considered low-risk, they still need to meet regulatory compliance standards set by authorities like the Central Drugs Standard Control Organization (CDSCO). Certification is essential to demonstrate compliance.

Impact of COVID-19 on India Medical Device Testing and Certification Market

The COVID-19 pandemic resulted in a sharp rise in the requirement for medical equipment, including ventilators, diagnostic tools, personal protective gear (PPE), and other healthcare devices. This surge in demand necessitated rapid testing and certification procedures to ensure the quality and safety of these products. To address the urgent healthcare needs arising from the pandemic, regulatory bodies in India, such as the Central Drugs Standard Control Organization (CDSCO), accelerated the approval and certification processes, particularly for critical medical devices like COVID-19 diagnostic kits and ventilators. Disruptions in the global supply chain, brought about by lockdowns and transportation restrictions, created shortages of specific medical devices. This situation underscored the need for domestic manufacturing and expedited certification processes.

Competitive Landscape

The India medical device testing and certification market is fragmented, with numerous players serving the market. The key players dominating the India medical device testing and certification market are SRL Limited, Bureau Veritas India, SGS India Private Limited, Intertek India Private Limited, UL India Private Limited, Asia Quality Focus, Micom Laboratories India Pvt Ltd, Toxikon India Pvt Ltd, Cliniminds, and RMS Healthcare. These players use various strategies including facility expansion, product diversification, alliances, collaborations, partnerships, and acquisition to expand their customer reach and gain a competitive edge in the overall market.

Don’t miss the business opportunity of the India Medical Device Testing and Certification Market. Consult our analysts to gain crucial insights and facilitate your business growth.

The report's in-depth analysis provides information about growth potential, upcoming trends, and the India Medical Device Testing and Certification Market statistics. It also highlights the factors driving forecasts of total market size. The report promises to provide recent technology trends in the India Medical Device Testing and Certification Market along with industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyses the growth drivers, challenges, and competitive dynamics of the market.

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