Globalization and international trade has drastically changed the face of the world. In the last couple of years, communication and trade has bloomed between the developed and developing countries. The  wave of globalization, in the healthcare domain, has resulted in  a  surge of import and export of medical devices to various parts of the world helping people get faster access to the best healthcare solutions and innovations.

This is great for Manufacturer, as they can grow their businesses now more than ever! However, it comes with an important responsibility of compliance i.e. to abide by the rules and regulations of the destination country before import or export. Here are some quick tips for US import and export:

All foreign firms importing medical devices (including radiation emitting devices) into the US market must fill out CBP forms and comply with the applicable U.S regulations before, during, and after the import. Every manufacturer importing into the U.S. must make sure they have the evidence for:

• Establishment and Registration
• Device Listing
• Compliance to Quality System Regulations (QSR)
• Medical Device Reporting of Adverse Events
• Medical Device Tracking Provisions (UDI, lot number, model number)
• Labelling Requirement
• Regulatory approval (510(k), PMA or Premarket Notification)
• Appointed US Agent (applicable to foreign based companies
• An Initial Importer (applicable to foreign based companies)

US Import Process

Medical devices imported into the U.S. must be FDA approved and must meet the requirements of CBP. Manufacturers must include appropriate information indicating compliance to the FDA

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¹ .Establishments involved in the production and distribution of the medical devices in the U.S are required to pay the annual registration fee. regulations. Products that are not compliant and which do not meet these requirements will be detained upon entry.

The same rules don’t apply to all. Who Must Register and List?

All the establishments can be registered using the FDA Unified Registration and Listing System (FURLS). Establishments must visit the Device Facility User Fee (DFUF) website for the payment of the user fee in order to proceed with the registration.  The annual registration user fee for this fiscal year (2018) is $4,624. This annual registration is mandatory for facilities that need to register.

Exporting from the U.S. Market 

Legally marketed devices in the U.S that follow export provisions as per FD&C Act can be exported to any part of the world without any prior FDA notification or approval. Depending on the country of export, an export certificate or letter that contains proof of the regulatory and marketing status of the products in the U.S market may be required.  Manufacturers exporting devices will be requested for one of the following:

• Export Certificates
• Export Permit Letter (under Section 802)
• Simple Notification (under Section 802)

All the above mentioned certificates/permit letters can be accessed through the CDRH Export Certification and Tracking System (CECATS) electronic systems in the FDA Unified Registration and Listing  Systems (FDA, FURLS).

Devices exported from the U.S, should produce a CFG or other regulatory documents depending on the destination country requirements. Failure to do so could result in delayed shipment and compliance issues.

Port of Entry Requirements for obtaining a CFG 

• Medical device needs to be imported into the US before filling CBP forms
• CBP Form 3461/7501, Bill of Lading (BOL), Airway Bill (AWB), invoice, purchase order, certificates of analysis, copies of labeling, and intended use statement are required
• Every establishment must have a device listing

Import/Export from a regulatory standpoint is a straightforward and a well established process. However, if the right steps are not followed this process can be perpetual resulting in  delayed shipment, product and revenue losses, or denial of export privileges. Elexes has assuaged/ assisted export and import process for many medical devices. Feel free to contact us at contact@elexes.com for further questions.

PC: Freepik