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Medical Device Logistics: Navigating FDA and Customs Compliance

Greetings and best wishes from KBMED! We are dedicated to informing you of the latest updates about our products, production, and global business development. Additionally, we aim to share insights into regulations, market trends, and technological advancements within the medical devices and healthcare sectors. In this newsletter issue, we are pleased to present a news article from Omniahealth by Jennifer Diaz, detailing regulatory requirements in the United States for importing and exporting medical devices.


 

The medical device market is a US$495 billion market and is expected to grow to over $700 billion by 2029. While the market offers great opportunities for manufacturers, medical device imports and exports also present unique safety challenges for policymakers. Businesses considering importing or exporting medical devices should do thorough research ahead of time and consult with a trade attorney to ensure compliance with all applicable regulations. Medical device importers and exporters should have a comprehensive plan to ensure their products meet all applicable regulatory requirements in the United States.

 

Importing Medical Devices 

Imports of medical devices are governed by the federal Food, Drug, and Cosmetic Act, which is administered by the Food and Drug Administration (FDA). All commercial imports of these

items are subject to approval by the FDA, prior to being cleared by U.S. Customs and Border Protection (CBP). 




Checklist to Import Medical Devices 

At the time of importation, the FDA has the authority to examine your products. Importers should ensure their devices comply with all applicable requirements, including: 

  • Premarket Notification 510(k): Some medical devices require premarket submissions to demonstrate that the devices are safe and effective. 

  • Premarket Approval (PMA): The FDA’s process of regulatory and scientific review to evaluate the safety and effectiveness of certain devices. 

  • Establishment Registration and Listing: Establishments that produce and distribute medical devices in the United States are required to register with the FDA. Most of these establishments are also required to list the device at that establishment. 

  • Labeling Requirements: Devices are properly labeled in accordance with FDA regulations. 

  • Medical Device Reporting: The importer has met the mandatory reporting requirements for medical devices. 

  • US Designated Agent: Foreign manufacturers must designate a U.S. agent who will be responsible for assisting the FDA with communicating with the foreign establishment. 

  • Quality Systems Regulation: The manufacturer must maintain a quality system that meets applicable FDA requirements. 

If the FDA finds that a medical device does not meet these requirements, the products may be detained and ultimately refused entry into the United States.   


 

FDA Enforcement Actions

The FDA engages in several import compliance and enforcement activities at the point of

entry. There are several enforcement and compliance actions the FDA may take:

  • Examination and Sample Collection: The FDA may examine samples of products offered for entry into the US. If the FDA decides to examine your products, a Notice of FDA Action will be issued.

  • Detention and Hearing: If the product appears to be in violation, the product is subject to refusal, and a Notice of FDA Action will be issued. The notice will specify the nature of the violation and provide the importer an opportunity to present supporting evidence to overcome the violation, within a specified time period.

  • Import Alerts/Detention Without Physical Examination (DWPE): Import alerts inform FDA field staff that the agency has enough evidence or other information to allow for DWPE of products. Products are subject to DWPE based on past violations. These violations could be related to the product, manufacturer, shipper and/or other information indicating the product may be in violation of FDA laws.

  • Notice of Redelivery: If the FDA refuses the admission of a product or if a notice of sampling is not complied with, CBP will demand the redelivery of the product to CBP custody.

  • Notice of Refusal: Products can be refused entry into the US if they do not meet the FDA’s requirements. Importers have 90 days to export or destroy the products.

  • Notice of Penalty or Liquidated Damages: CBP may impose liquidated damages for failure to redeliver, export, or destroy merchandise in accordance with the agency’s requirements.


The standard for detention and refusal is low — detention is permissible without actual observation of a product or its labelling. Additionally, the ability to challenge the FDA is limited almost exclusively to legal, as opposed to factual, issues.


 

Exporting Medical Devices 


Significant purchasing power lies outside the United States. Exporting medical devices enables manufacturers to broaden their scope and reach new markets. However, exporters need to be diligent in planning for compliance both in the United States and in foreign markets they are exporting to.

In the United States, the Department of Commerce and the State Department are the primary governing bodies for exports. For medical devices, foreign governments may ask for an Export Certification from the FDA.

There are significant benefits to medical device manufacturers who can import and export their products. However, customs penalties can be severe and range from fines to criminal penalties in some cases. The best way to ensure compliance with all regulatory requirements is to take care in developing a comprehensive compliance plan and to have the plan reviewed by a trade attorney.

Stay tuned for more updates on KBMED innovative safe medical disposable products. We sincerely appreciate your continued trust in KBMED as your preferred supplier of medical disposable products. Rest assured, we are working diligently to meet the demands and exceed your expectations.

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