What is BSI's role in global market access?
We are a global organization, trusted and recognized around the world with 84 offices in 31 countries. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.
We hold recognition by SCC (CMDCAS, Canada), MHLW (PMD Act, Japan), Taiwan FDA (TCP program), Hong Kong MDCO (as a Hong Kong CAB), Malaysian MoH (as a Malaysian CAB), and ANVISA (INMETRO, Brazil). We are also recognized as an MDSAP Auditing Organization.
We offer a portfolio of products and services for each stage of your certification journey, and we are committed to establishing long-term, proactive relationships with our customers.