Training Course Syllabus:
FDA Regulations for Importing and Exporting Medical Devices Webinar
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Mukesh Kumar
Both import and export of medical devices from and to the US requires complex documentation requirements from the importer and exporter before custom clearance. FDA and US customs work closely to control the incoming and outgoing 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.
This webinar will provide practical instructions on 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 webinar is intended for US-based and non-US manufactures importing or exporting 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.
Objectives of the Presentation:
This webinar focuses on presenting detailed explanation on areas like:
- FDA´s processes of import and export of medical devices
- Navigating the CECATS
- Notification and Record Keeping Requirements
- Regulatory requirements for medical devices intended for import and export
- Prior Notice process
- Role of US agent for import and export of medical devices
- Dealing with refusal to issue export certificates and import permits