European Market Access

As a Notified Body under the Medical Device Directives, we can support your product certification so you can sell your products in the European Union.

Find out more about CE Marking

Canadian market access

As a CMDCAS recognised registrar, we can provide you with an ISO 13485 certificate to help you gain market access to Canada.

Learn more about CMDCAS

Japanese market access

At BSI we can support your market access in Japan by ensuring your medical device products meet the requirements of the PMD Act.

Read more about Japanese regulations

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?

We are an approved “full scope” Notified Body recognized by the European Commission for 17 Directives and also hold recognition by CMDCAS (Canada), PMD Act (Japan), Taiwan FDA (under TCP program), Hong Kong MDCO (under Hong Kong CAB), Malaysia CAB services, and INMETRO (Brazil). We are also an accredited MDSAP Auditing Organization.

We offer a results-focused 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 180 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.
  • Experience – our team has over 1750 years’ combined industry and regulatory experience, so we understand the challenges you face.