Global market access

Global market access

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance

We offer a wide range of proven regulatory and quality management programs that work together for full international compliance
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Global market access for medical device manufacturers

With more than 70,000 certified locations and clients in over 180 countries, we  work with international regulators to enable medical device manufacturers all over the world get their products to market quickly while complying with the latest regulatory requirements. 

By working with BSI, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of product and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including research and development, manufacturing and quality assurance.

How can BSI support you in global market access?

With a global network of over 4,600 colleagues and over 84,000 clients operating in 195 countries across a range of industries, we work with international regulators to support medical device manufacturers all over the world in bringing their products to market efficiently while complying with the latest regulatory requirements.

We are an approved “full scope” Notified Body recognized by the European Commission for 17 Directives and also 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.

Select a country below to learn more about how BSI can support your access to these markets:

Why choose BSI as your notified body?

  • Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
  • Global access – we operate in over 150 countries with more than 100 years of experience and offices around the world to serve you.
  • Speed-to-market – providing flexible solutions for manufacturers needing accelerated pathways to global markets.
  • Confidence – our stringent review process combines speed with experience, integrity, independence and predictability.
  • Partnership – we focus on establishing a partnership with each client so we can work together to meet their goals.