PUBLISHER: Grand View Research | PRODUCT CODE: 1771471
PUBLISHER: Grand View Research | PRODUCT CODE: 1771471
Medical Device Testing, Inspection And Certification Outsourcing Market Summary
The global medical device testing, inspection, and certification outsourcing market size was estimated at USD 3.18 billion in 2024 and is projected to reach USD 5.11 billion by 2030, growing at a CAGR of 8.48% from 2025 to 2030. The market growth is primarily attributable to the stringent regulatory scenario, accelerated innovation cycles, and expanding device complexity across diagnostic, therapeutic, and wearable categories.
Growing scrutiny from several regulatory bodies across regions, such as the U.S. FDA, EU MDR, and China's NMPA, has enhanced demand for third-party TIC expertise for compliance, safety assurance, and faster market access. Moreover, rising complexity in device design, particularly with the integration of software, connectivity, and AI, demands advanced testing capabilities that several in-house teams lack, offering growth opportunities. Furthermore, increasing cost pressures and the need for operational efficiency also enhance outsourcing TIC services, especially among small and mid-sized manufacturers. Growing global trade of medical devices further boosts demand for standardized certification services.
The accelerating commercialization of high-risk, technologically advanced Class II and III devices, including implantables, active therapeutic systems, and digital diagnostics, has strengthened requirements for clinical validation, electrical safety, biocompatibility, and cybersecurity testing. These devices demand multi-domain TIC expertise, driving demand for specialized third-party service providers. Furthermore, mandatory post-market surveillance (PMS), vigilance reporting, and periodic safety update reporting (PSUR) requirements are increasing the volume and complexity of post-market evidence generation and compliance activities. For instance, the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced more severe compliance assessments, especially for Class II and III devices. Regulatory authorities often require continuous performance evaluation across device lifecycles, leading OEMs to outsource recurring testing, risk management, and adverse event analytics to qualified TIC partners.
Additionally, global regulators are strengthening oversight on notified bodies and authorized representatives, improving the technical documentation standards required for approvals and renewals. For instance, in April 2021, the FDA accredited UL as an ISO/IEC 17025 laboratory under the Accreditation Scheme for Conformity Assessment (ASCA) for medical device safety testing. Thus, rising regulatory compliance pressure prompts OEMs to mitigate regulatory risk, compress timelines, and optimize cost structures by engaging TIC vendors with accredited capabilities, cross-border regulatory knowledge, and integrated testing portfolios. As a result, the TIC outsourcing market is shifting from a transactional service model toward long-term, compliance-driven partnerships with embedded regulatory intelligence and quality systems expertise.
The globalization of medical device manufacturing and supply chains is a key structural driver accelerating growth in the global medical device testing, inspection, and certification (TIC) outsourcing industry. As Original Equipment Manufacturers (OEMs) diversify production across multiple geographies to mitigate cost, tariff, and regulatory risks, TIC requirements become more complex, multi-jurisdictional, and frequent. This geographic distribution requires independent third-party verification to enhance consistent compliance with region-specific regulatory frameworks such as FDA (U.S.), MDR (EU), and PMDA (Japan), alongside ISO and IEC standards. Moreover, the proliferation of contract manufacturing organizations (CMOs) and increased outsourcing intensity across design, assembly, and component production enhance quality assurance complexity. Global supply chains expand traceability and accountability risks, thereby expanding demand for end-to-end TIC services, particularly in high-risk categories such as implantables, diagnostics, and digitally connected devices.
In parallel, real-time data exchange and software integration in device supply chains require rigorous cybersecurity and software validation audits, further expanding the medical device TIC outsourcing market growth. In addition, as regulatory authorities increase scrutiny of imported devices, manufacturers increasingly rely on third-party TIC providers to expedite market entry while minimizing compliance lapses. For instance, in March 2023, the U.S. FDA introduced Section 524B on "Ensuring Cybersecurity of Devices" under the Consolidated Appropriations Act (Omnibus), 2023, mandating that all new medical device premarket submissions include cybersecurity information. This marked the first legally binding cybersecurity requirement within the Federal Food, Drug, and Cosmetic Act (FD&C Act), impacting all Class II and III device submissions. As a result, TIC outsourcing is evolving from a transactional compliance function to a strategic risk mitigation lever within globalized medical device manufacturing ecosystems.
Global Medical Device Testing, Inspection And Certification Outsourcing Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global medical device testing, inspection and certification outsourcing market report based on service, drug class, end use, and region: