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Streamlining Certification for Imported Medical Devices from Outside the US

This act simplifies the certification process for medical devices manufactured outside the United States and imported into the US. The goal is to streamline access to these products in the American market, potentially affecting the availability and variety of medical equipment for citizens.
Key points
Facilitates obtaining export certifications for medical devices manufactured outside the US but intended for the American market.
Establishes new rules for documentation and fees for certifying imported medical devices.
Ensures that certifications for imported devices will contain the same key information as Certificates to Foreign Government.
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Additional Information
Print number: 117_S_4391
Sponsor: Sen. Cassidy, Bill [R-LA]
Process start date: 2022-06-14