Overview
The U.S. Food and Drug Administration (FDA) oversees the adherence of medical instruments (including in vitro diagnostics) and electronic products emitting radiation to relevant U.S. guidelines when presented for import into the U.S. Foreign facilities need to adhere to these pertinent guidelines before, during, and after the importation of the medical device or radiation-emitting electronic product into the United States or its territories. The FDA does not acknowledge regulatory approvals from other nations. The item must conform to the relevant FDA regulation.
Medical Devices
The FDA examines and enforces relevant prerequisites for medical devices when a medical device is brought into or presented for importation into the United States. The oversight of the medical device program falls under the responsibility of the FDA’s Center for Devices and Radiological Health (CDRH).
Manufacturers from Abroad of Medical Devices
A foreign producer refers to a manufacturer situated outside of the United States. To import a device into the U.S., foreign manufacturers must adhere to applicable U.S. regulations.
The fundamental regulatory criteria encompass:
- Establishment registration
- Listing of Medical Devices
- Quality System
- Premarket Notification [510(k)], unless exempt, or Premarket Approval
- Labeling
- Medical Device Reporting.
As part of its initial and updated registration details, a foreign manufacturer is obliged to designate a United States agent. An overseas manufacturing site is subject to FDA scrutiny, medical device tracking (if necessary), and the reporting of adverse events.
Initial Importers of Medical Instruments
An initial importer, as per Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g), is any importer who advances the promotion of a device from a foreign manufacturer to the individual responsible for the final delivery or sale of the device to the ultimate consumer or user but does not alter the packaging, container, wrapper, or labeling of the device or its package.
An initial importer of a medical device must adhere to the subsequent regulatory criteria:
- Establishment registration
- Medical Device Reporting (MDR) (21 CFR 803)
- Reports of Corrections and Removals (21 CFR 806)
- Medical Device Tracking (21 CFR 821), where applicable.
In accordance with the MDR regulations, an importer is obligated to report incidents where a device might have caused or contributed to a death or serious injury, along with specific malfunctions. The importer is required to maintain an MDR event file for each adverse event, and all product complaints, including MDR and non-MDR events, must be forwarded to the manufacturer. Under the Medical Device Tracking regulation, certain devices must undergo tracking throughout the distribution chain.
Radiation-Emitting Electronic Products
Radiation-emitting electronic products can be classified as either medical or non-medical devices. If a radiation-emitting electronic product is also a medical device, it must fulfill the relevant medical device requirements outlined in the preceding section. All radiation-emitting electronic products must comply with 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 importing 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 the submission of radiation safety product reports.
A foreign manufacturer submits a radiation safety product report to the FDA for examination. Upon receipt, the FDA assigns the report an accession number, a unique identifier maintained in an FDA database for the product safety report. An importer may submit a radiation safety product report on behalf of a foreign manufacturer.
Importers of Radiation-Emitting Electronic Products
An importer can submit a radiation safety product report on behalf of a manufacturer. If a radiation-emitting electronic product is subject to a performance standard, the importer must send a written declaration, “Declaration of Products Subject to Radiation Control Standards,” Form FDA 2877, to the FDA. The importer is also required to provide import entry information, including an accession number if applicable, through U.S. Customs and Border Protection (CBP) to the FDA.
Import Process
All medical devices imported into the United States (U.S.) must satisfy the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and the FDA. Products failing to meet FDA regulatory requirements may be detained upon entry.
CBP administers the Tariff Act of 1930 as amended, with primary duties including the assessment and collection of all duties, taxes, and fees on imported merchandise, administering and reviewing import entry forms, enforcing CBP and related laws, and administering certain navigation laws and treaties. An agreement between the FDA and CBP exists 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 filed with CBP will be electronically submitted to the FDA for review. An importer or customs broker must submit required entry information to CBP through the Automated Commercial Environment (ACE) system.
The necessary entry information includes:
- Country of origin
- Importation product code, a combination of the FDA panel code and FDA product code
- Importer product description
- Manufacturer
- Shipper
- Applicable affirmations of compliance codes
- Harmonized Tariff Schedule (HTS) code for the product described in the importing documents.
The HTS code classifies items imported into the U.S., providing applicable tariff rates and statistical categories. For inquiries and guidance on tariff rates, please contact your local CBP Port of Entry.
You can expedite the entry review process by submitting accurate and complete information at the time of filing and responding promptly to requests for additional information.
Importation for Export
An organization can bring (introduce into the United States) components, elements, subassemblies, etc., for additional processing or integration into unapproved devices, which will subsequently be exported (taken outside of the United States). Importing a finalized device that is not lawfully available in the United States is not permissible for any reason, even if the device is intended for importation into the United States solely for later exportation. A fully developed medical device that complies with legal marketing regulations in the United States has received Premarket Notification [510(k)] clearance, De Novo approval, Premarket Approval application approval, or falls under an exemption. The “Import for Export” provision cannot be utilized for storing items in the United States.
Individual Importation
Personal importation refers to bringing in a supply of a medical device for up to 90 days, not intended for further sale or distribution within the United States. These devices can be transported in luggage or shipped through a courier or international mail service. Dropshipping involves importing a U.S. legally approved device for one individual.
References
https://www.fda.gov/media/71776/download?attachment
https://www.fda.gov/about-fda/page-not-found
https://www.fda.gov/industry/import-program-food-and-drug-administration-fda
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-procedures-manual
