FDA Regulations for Importing and Exporting Medical Devices

Duration: 60 Minutes
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.
fda regulations for medical devices
Instructor: Mukesh Kumar
Product ID: 500839

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
Who can Benefit:
  • Medical device Manufactures, Importers and Exporters
  • Compliance Officers
  • Logistics/Supply Chain Managers and Analysts
  • Trade Regulatory/Legislative Affairs Professionals
  • Sales/Marketing Personnel
  • International Business Operations
  • Customs or Trade Compliance Personnel or Officers
  • Import-Export or Global Trade Directors or Managers
  • Import-Export Supervisors
  • Customs Brokers
  • Companies interested in importing or exporting medical devices to and from the US

This webinar is a part of "Import Export Regulations" Webinar Series. Click here to know more.


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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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