The CB Scheme

Access growing Medical Device Markets around the world with CB Testing and Certification from Intertek's CB Scheme program

The IECEE CB Scheme offers a simplified approach to obtaining multiple national safety certifications with a single test report and Certificate, allowing you to market your medical device in more than 50 countries! As a National Certification Body (NCB) and CB Testing Laboratory (CBTL) to the CB Scheme - Intertek issues more CB certificates than any other National Certification body around the world.

When you engage in our globally recognized market-entry program, we’ll manage your entire global certification process from start to finish.

Australia – Leverage your CE Marking to secure regulatory approval from Australia’s Therapeutic Goods Administration (TGA).

Canada – Find the support you need to navigate the requirements of Health Canada and Canadian Medical Devices Regulations (CMDR), register for a Medical Device License (MDL), and ensure your Quality Management System is ISO 13485 compliant.

China - Before selling your medical device in the Chinese market, you must obtain the China Compulsory Certification Mark (CCC Mark), comply with SFDA regulations, and ensure your Quality Management System is ISO 13485 compliant.

Japan – Prior to entering the Japanese market, your Class II Designated Controlled medical device must be certified by a third-party laboratory to bear the PSE Mark. We provide local testing to required IEC 60601 safety standards and Quality Management System audits.



*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.


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