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Medical Device, FDA Regulations required for export to the US

Feb 09 2022

When exporting medical devices to the US, what are the regulations?

All medical devices imported into the United States (U.S.) must meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA.

Products that do not meet FDA regulatory requirements may be detained upon entry.

CBP administers the Tariff Act of 1930 as amended.

The primary duties include :

  • assessment and collection of all duties

  • taxes and fees on imported merchandise

  • administering and reviewing import entry forms

  • enforcing CBP and related laws

  • administering certain navigation laws and treaties

FDA and CBP have an agreement for the cooperative enforcement of the Food ,Drug and Cosmetic Act, Section 801, Title 21 U.S.C. 381.

An entry for an FDA regulated product that is filled with CBP, will also be electronically submitted to FDA for review. An Importer or customs broker is required to submit required entry information to CBP through the Automated Commercial Environment (ACE) system.

FDA Regulations required for customs clearance

The regulations required for customs clearance are as follows :

Class I Medical Device

  • registration and product listing

  • requires annual renewal of registration (renewal every year between 10/01 - 12/31)

  • registered as the importer in the US

  • FDA compliant labeling

  • (For overseas companies) US Agent required designation

  • QMS for FDA factory inspection

Class II Medical Device

  • 510(k) Certification

  • same as above for Class I Medical Device requirements

Additional documents required for customs clearance may occur.

In this case, please contact ' Customer Broker '

Importers must comply with various regulations such as company registration,

importer registration, product listing, and labeling. It is necessary to be aware of and prepare in advance to prevent any difficulties.

Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.

Our services allow manufacturers to spend more time developing their devices

rather than searching for distributors, negotiating contracts, and learning regulations.

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276


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