Regulatory Affairs
Sonosite is comprised of an innovative team of professionals with many years of experience in medical diagnostic ultrasound technology. Sonosite is at the forefront of defining a world-class standard of quality management for ultrasound manufacturing. Sonosite products are designed, manufactured, and distributed in full accordance with the requirements of domestic and international laws and regulations. Evidence of regulatory compliance is available upon request.
REGULATORY AFFAIRS CONTACT
Ian McDonald
Vice President, RA, QA, and Compliance Officer
For Regulatory Affairs general information requests, please click here.
Countries
UNITED STATES / CANADA
All Sonosite products marketed in the United States and Canada meet the marketing requirements of the U.S. FDA and Health Canada’s Therapeutic Products Directorate respectively.
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U.S. FDA 510(k) database where copies of 510(k) substantial equivalence decisions along with device summaries of safety and effectiveness.
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Health Canada Medical Devices Active License Listing database for each product listed.
EUROPEAN UNION
Sonosite products meet the applicable requirements of the European Medical Device Directive (MDD) and are therefore CE marked prior to being placed on the market.
For each Sonosite device marketed within the European Union Sonosite prepares a declaration of conformity with the MDD and applies CE marking. For other countries, outside of the European Union, additional documentation is available.
To request a copy of the product's Declaration of Conformity Certificate, please click here.
REST OF WORLD
In addition, the U.S. FDA provides export certificates, known as Certificates to Foreign Government (CFG) that certify a particular device may be marketed in, and legally exported from the United States of America and that the manufacturing plants in which the device is produced is subject to periodic inspections and that the last inspection showed that the plant appeared to be in substantial compliance with good manufacturing practice requirements.
To request a copy of the product's Certificate to Foreign Government, please click here.