Webinars >>FDA Regulations
FDA Regulated Import and Export of Medical Devices
Are you planning to import medical devices into the US or export devices from the US to another country? Do you know that both import and export of medical devices from and to the US requires complex documentation requirements from the importer-exporter before custom clearance. FDA and US customs have created an intricate distribution of responsibilities and tracking system to control incoming and outgoing medical devices. Non-US importers must meet all applicable US medical device regulations in order to import devices into the US. The regulatory requirements include registration of manufacturing site, listing of devices, compliance with QSR, adverse events reporting requirements, and applicable market approvals such as 510(k) or PMA. One needs to designate a US agent and be subject to FDA audits. Similarly, exporter of medical devices, both approved for marketing in the US and unapproved or investigational devices, must provide compliance documents to FDA and customs. This seminar will provide practical instructions in the process of getting import and export documents such as certificates and permits from FDA including description of key terms, concepts, and common issues that importers-exporters of medical devices are likely to encounter.
Why should you attend:
This seminar is intended for US-based and non-US manufactures importing or exporters medical devices to-from the US who wish to have a better understanding of how medical devices are imported into or exported from the U.S. Attendees will be introduced to the types of documentations, conditions under which FDA issues or denies export certificates or import permits, legal requirements, fees, and regulatory requirements for medical devices. Attending this training will help you to better manage your import and export compliance activities and help support your logistics supply chain.
Areas Covered in the Session:
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: firstname.lastname@example.org