Omsbar Medical Device Design Manufacturing and Regulatory Services



Medical Device Design Clinical Evaluation Export Certification Project Management Product Registration Quality Management Regulatory Affairs Verification and Validation OMSBAR Contact Information Training Design Manufacturing Omsbar Medical Device Consultancy


Export Certification
  CE Marking in the European Economic Area (EEA) and approval to market from the FDA are necessary to place medical devices on the market within Europe and the USA. Additional licences and approvals are necessary to place product legally on the market in other territories.
  An Export Certificate is a ‘visa’ for shipping a medical device into a particular country. One export certificate is required for each equipment type, often needing complicated technical submissions. Submission of the certification file and its approval is often necessary prior to first shipment. The Export License is as a ‘landing card’ for shipping a particular piece of equipment. An export license is required for every individual shipment and is usually required prior to each shipment. Areas such as Eastern Europe, China, Japan, Russia, The Middle East and Asia require export certificates.
  Information required for registrations vary from country to country and can emphasise sterile products, electrical products or both and can range from straightforward notifications to full blown technical submissions. In some areas, manufacturing site registrations or supplementary product tests are necessary. To comply with some United Nations requirements, licenses to communicate may be necessary.
 

Omsbar provides specialist information and services to obtain export certificates, certificates of origin and licenses to communicate for countries outside the USA and the European Economic Area.