The IECEE CB Scheme and Medical Devices

Access growing Medical Device Markets around the world with IECEE CB Scheme Testing and Certification from Intertek's four IECEE National Certification Bodies

The IECEE CB Scheme offers a one-stop approach to obtain multiple national safety certifications with a single CB Test Certificate and Report.

The IECEE Scheme, based on IEC and ISO harmonized international standards, allows for a true one-stop approach to obtain multiple national safety certifications with a single CB Test Certificate and Report. The program helps reduce trade barriers caused by different certification requirements in different countries, allowing Medical Device manufacturers to access existing, new and developing global markets. It eliminates delays and costs for repetitive testing, allowing companies to market their products faster while reducing overall costs.

Countries Participating in the CB Scheme

  • Argentina
  • Australia
  • Austria
  • Bahrain
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Columbia
  • Croatia
  • Czech Republic
  • Côte d'Ivoire
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Kenya
  • Republic of Korea
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Nigeria
  • Norway
  • Pakistan
  • Poland

  • Portugal
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • Turkey
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • United States of America
  • Vietnam

Local Testing for Worldwide Safety Compliance

Through our global network of testing labs, Intertek possesses four National IECEE CB Scheme Certification Bodies (NCBs) in Singapore, Sweden, the United Kingdom and the United States of America for more than 45 associated CB Testing Laboratories worldwide.

 

 

*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.

 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 116 296 1620
S. AMER:
+55 11 2842 0444
APAC:
+86 400 886 9926
Benelux:
+31 88 126 8888
Germany
+49 711 27311 152
UAE
+971 4 317 8777
India
+91 11 4159 5408
Hong Kong:
+852 2173 8888