The CB Scheme

Access the World’s Fastest Growing Medical Device Markets

The IECEE CB Scheme offers a simplified approach to obtaining multiple national safety certifications with a single test report so you can 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.

 

 

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 1372 370900
S. AMER:
+55 11 2842 0444
APAC:
+86 400 886 9926
EMEA:
+46 8 750 0000
Germany
+49 711 27311 152
UAE
+971 4 317 8777
 

Regulatory Requirements for Medical Equipment