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), 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.