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 work closely to control the incoming and outgoing of medical devices using an intricate distribution of responsibilities and tracking systems. Non-US importers must meet all applicable US medical device regulations in order to import devices into the US even if the product is authorized for marketing in another country. Many devices imported may not be approved for sale in the country of origin.
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. An exporter may need to request an export permit letter or export certificate, or it may need to submit a simple notification. Devices exported for research use only require the certificate of exportability. Exporters need to understand FDA electronic tracking system to request export documentations.
Join this audio conference by expert speaker Dr. Mukesh Kumar to have practical insights into 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.
Benefits of the Session
This audio conference is intended for US-based and non-US manufacturers importing or exporting medical devices to and from the US who wish to have a better understanding of how medical devices are imported into or exported from the U.S. You 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.
Who should attend?
- Dr. David Lim
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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