B. Braun has a complete in-house regulatory staff for both devices and drugs. Our analysts will review all labeling to ensure compliance with FDA and global regulations. We offer support in filing drug applications, 510(k)s, PMAs and CE markings and assist in the regulatory assessment of product changes. B. Braun can also provide NAFTA certificates and country-of-origin letters.
Not all products are registered and approved for sale in all countries or regions. Please contact your country representative for product availability.