Jun 17 2022
The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in vitro diagnostics) and radiation-emitting electronic products comply with applicable U.S. regulations when offered for importation into the United States. Foreign establishments must comply with these applicable regulations before, during, and after the medical device or radiation-emitting electronic product is imported into the United States or territory. FDA does not recognize regulatory authorizations from other countries. The product must meet the applicable FDA regulation.
Foreign Manufacturers of Medical Devices
Foreign manufacturers must meet applicable U.S. regulations in order to import a device into the U.S.
The basic regulatory requirements include :
Medical Device Listing
Premarket Notification [510(k)], unless exempt, or Premarket Approval
Medical Device Reporting.
A foreign manufacturer must designate a United States agent as a part of its initial and updated registration information. A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting.
More information about U.S. regulatory requirements.
Initial Importers of Medical Devices
An initial importer is defined in Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g) as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
An initial importer of a medical device is required to comply with the following regulatory requirements:
Medical Device Reporting (MDR) (21 CFR 803)
Reports of Corrections and Removals (21 CFR 806)
Medical Device Tracking (21 CFR 821), where applicable.
Radiation-Emitting Electronic Products
Radiation-emitting electronic products may be medical devices or non-medical devices. A radiation-emitting electronic product that is also a medical device must meet the applicable medical device requirements described in the above section. All radiation-emitting electronic products must meet the radiation safety-related requirements of the Federal Food, Drug, and Cosmetic Act, Subchapter C: Electronic Product Radiation Control.
Foreign Manufacturers of Radiation-Emitting Electronic Products
A foreign manufacturer who imports a radiation-emitting electronic product into the United States must meet the radiation safety-related requirements of the Federal Food, Drug, and Cosmetic Act, Subchapter C: Electronic Product Radiation Control.
These requirements include: performance standards, labeling, and submission of radiation safety product reports.
A foreign manufacturer submits a radiation safety product report to FDA for review. Upon receipt, FDA assigns the report an accession number. An accession number is a unique identifier for the product safety report maintained in an FDA database. An importer may submit a radiation safety product report on behalf of a foreign manufacturer.
More information about importing electronic products.
Importers of Radiation-Emitting Electronic Products
An importer may submit a radiation safety product report on behalf of a manufacturer. An importer of a radiation-emitting electronic product subject to a performance standard is required to send to FDA a written declaration on “Declaration of Products Subject to Radiation Control Standards,” Form FDA 2877. The importer must also provide import entry information, including an accession number, if appropriate, through U.S. Customs and Border Protection (CBP) to FDA.
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.
An entry for an FDA regulated product that is filed with CBP, will also be electronically submitted to FDA for review.
The required entry information includes:
country of origin
importation product code, which is a combination of the FDA panel code and FDA product code
importer product description
applicable affirmations of compliance codes
Harmonized Tariff Schedule (HTS) code for the product described in the importing documents.
You may expedite the entry review process
by submitting accurate and complete information at the time of filing
and by responding to requests for additional information in a timely manner.
Provision Consulting Group will help you with your import process,
understanding customs, and FDA requirements.
We'll take care of your entrance into the US market
and all the complex regulatory requirements.
If you have questions about FDA regulation of medical devices
or importing of medical devices to the United States,
please CONTACT US.