Rockville, Maryland — September 25, 2026 — New Fact.MR analysis finds that the global healthcare and medical devices testing, inspection and certification market is valued at USD 12.8 billion in 2026 and is forecast to reach USD 28.9 billion by 2036, expanding at a CAGR of 8.5% from 2026 to 2036. The market is expected to generate an absolute opportunity of USD 16.1 billion during the forecast period as medical device manufacturers increase reliance on testing, inspection, certification, and regulatory documentation services.
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Regulatory evidence requirements are becoming a central factor shaping demand for healthcare and medical device TIC services. Manufacturers increasingly require electrical and mechanical checks before progressing through regulated market-access processes, while laboratories with calibrated equipment can support outsourced testing requirements. The growing presence of connected devices and software-enabled medical products is adding another layer of demand, particularly for cybersecurity assessment and performance evidence. According to Fact.MR, the FDA's Center for Devices and Radiological Health reported that more than 1,300 AI-enabled medical devices had been authorized to date in its 2025 Annual Report.
Testing Services are projected to remain the leading service type, accounting for 46.0% of the market in 2026. Their leading position reflects the need to establish evidence that devices meet safety and performance requirements before inspection and certification activities advance. Medical Device Performance Testing is expected to hold 41.0% of the application segment, while Medical Device Manufacturers are projected to represent 44.0% of end-user demand. Laboratory-based Services are estimated to account for 52.0% of service delivery, and Mechanical & Electrical Testing is forecast to lead testing technology with a 48.0% share.
The USA is expected to record the fastest growth among the countries covered in the report, with a CAGR of 9.3% between 2026 and 2036. Mature regulatory-service demand and broad use of external laboratories before filing are supporting adoption, with manufacturers seeking providers capable of combining safety testing with documentation support. Germany follows at 9.0% CAGR, supported by its strong medical technology manufacturing base and the need to maintain conformity evidence alongside engineering and production activities. The European Commission's Decision (EU) 2025/2371 made the first four EUDAMED modules mandatory from May 28, 2026, adding registration, UDI/device, notified-body certificate, and market-surveillance requirements to European medical device files.
The UK is projected to expand at a CAGR of 8.7% through 2036, with clinical research depth and product-documentation requirements contributing to demand. Fact.MR notes that the UK's market is also being influenced by regulatory developments affecting post-market surveillance. The Medicines and Healthcare products Regulatory Agency stated that Great Britain's new post-market surveillance requirements apply to devices placed on the market or put into service from June 16, 2025.
Beyond these three markets, Japan is projected to grow at 8.3% CAGR, followed by Canada at 8.0%, France at 7.7%, and South Korea at 7.3%. Fact.MR identifies regulatory evidence burden, outsourced laboratory capacity, software and cybersecurity review, and electrical and mechanical safety testing among the factors supporting market expansion. Opportunities include early regulatory evidence planning, connected-device review, home-use device testing, and sterility and packaging checks.
At the same time, submission rework costs, laboratory capacity bottlenecks, approval-route documentation requirements, and shortages of skilled assessors could limit market expansion. Manufacturers may face additional testing expenses when evidence gaps require retesting, while specialized laboratory capacity can become constrained when multiple companies seek approval support simultaneously.
The competitive landscape includes TÜV SÜD AG, SGS SA, Intertek Group plc, Bureau Veritas S.A., Dekra SE, UL Solutions Inc., Eurofins Scientific SE, BSI Group, and Nemko Group AS. Fact.MR highlights direct medical device testing and certification capabilities across these providers. Intertek expanded its Medical Notified Body scope under the EU MDR in July 2025, adding 16 new MDR codes and broadening assessment and certification coverage.
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As medical devices incorporate more software, connectivity, and advanced electronics, TIC providers are expected to support increasingly detailed safety, performance, conformity, and regulatory evidence requirements. The full Fact.MR report provides detailed analysis of service types, applications, end users, service delivery models, testing technologies, regional markets, country-level growth, and key companies.
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