Global Market Access for Medical Devices

Global market access

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

Europe

As a designated EU Notified Body, we can support your product certification so you can sell your products in the European Union.

Europe market access >

Japan

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

Japan market access >

Brazil

As an accredited MDSAP Auditing Organization, we are authorized by the participating RA to audit under MDSAP requirements.

Brazil market access >

Canada

As an MDSAP Auditing Organization, we can provide you with an ISO 13485 certificate to help you gain market access to Canada.

Canada market access >

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.

UKCA for medical devices and IVDs

Download our UKCA webinar faqs to know more about taking devices to market in Great Britain post Brexit.

Download the faqs >

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.

Learn how BSI can support your access to these markets

Brazil

All medical devices in Brazil are regulated by the Brazilian Health Surveillance Agency (ANVISA).

Brazil market access >

Canada

Health Canada will only accept MDSAP for manufacturers who market their devices in Canada.

Canada market access >

Europe

A medical device complying with Directives and Regulations can only be sold in Europe with a CE mark.

Europe market access >

Hong Kong

In Hong Kong manufacturers and importers can opt for voluntary registration under MDACS.

Hong Kong access >

Japan

The distribution of medical devices in Japan is regulated in accordance with the PMD Act.

Japan market access >

Malaysia

The regulation of medical devices in Malaysia is carried out by the regulatory authority called MDB.

Malaysia market access >

Taiwan

Manufacturers wishing to sell in Taiwan must comply with registration requirements of the TFDA.

Taiwan market access >

United States

The FDA is to protect public health by allowing only safe and effective products to enter the market.

United States access >

How can BSI support you in global market access?

The benefits of having experienced, professional and well qualified technical specialists cannot be overstated in the complex and ever-changing medical device industry.

BSI Medical Devices has a team of over 750 colleagues; within that team are our technical experts with experience encompassing the full range of medical devices and management system standards.

Clients work with us because we understand the challenges medical device manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies.

Find out more about the notified body >