Saturday, April 20, 2024

Streamlining Medical Devices Export Documentation: FDA’s Digital Revolution

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The US Food and Drug Administration (FDA) has initiated a significant shift in its approach to issuing export documents for medical devices. This change, effective from January 2, 2024, marks the transition from traditional paper-based methods to electronic formats. The FDA’s move is aimed at simplifying the process, reducing the time and effort required for manufacturers to market their products in international markets.

In a detailed communication to the industry, the FDA outlined the specifics of this transition. The change encompasses a range of critical documents, including Certificates to Foreign Governments (CFG), Certificates of Exportability (COE), and Non-Clinical Research Use Only Certificates (NCR). Additionally, the FDA has introduced electronic formats for Certificates to Foreign Governments for Device Not Exported from the United States (CFG-NE) and Export Permit Letters.

FDA’s CDRH Takes Center Stage in Streamlining Medical Devices Export Documentation

A pivotal aspect of this shift is the role of the FDA’s Center for Devices and Radiological Health (CDRH). The CDRH is now responsible for delivering these export documents as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). Once manufacturers receive an email notification from the FDA confirming the approval and availability of their documents, they have a 45-day window to print or download these documents.

Stakeholders in the medical device export sector must note that documents requiring apostilles, authentications, and/or notarizations need to be printed in color to maintain their validity. This requirement underscores the FDA’s commitment to ensuring the authenticity and official status of these documents in the eyes of international authorities.

Medical Devices

Boosting Trust and Efficiency in Medical Device Export Documentation

The FDA’s move towards digitalization extends beyond the convenience of US manufacturers. It also offers streamlined access to foreign governments, regulatory agencies, and other interested parties like device distributors. These entities can now verify the authenticity of FDA-issued export certificates and documents using the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) tool. This verification is crucial for maintaining trust and compliance in international trade and can be easily done during the validity period of the documents. The FDA has enhanced this verification process by including QR codes on electronic export documents, which can be scanned to access the FECV.

In summary, the FDA’s transition to electronic formats for issuing export documents for medical devices represents a significant modernization effort. This change not only streamlines the process for US manufacturers but also ensures easier verification and validation of documents by foreign governments and regulatory bodies. By adopting electronic methods, the FDA has taken a step forward in improving the efficiency of the export process for medical devices, reflecting a broader trend toward digital transformation in regulatory practices. This move is expected to facilitate smoother international trade in medical devices, benefiting manufacturers, regulators, and end-users alike.


Resource: Emergo by UL, January 04, 2023

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