Medical Devices

From simple tools like thermometers to complex imaging systems and implantable devices, the medical device industry plays a critical role in improving patient outcomes and enhancing the quality of healthcare globally. With rapid technological advancements and increasing demand for innovative healthcare solutions, adhering to regulatory requirements is vital to meet the evolving needs of the medical industry.  

In the U.S., medical devices are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The FDA categorizes devices into three classes (Class I, II, and III) based on their risk level, with Class III devices being subject to the most rigorous regulations. Ensuring products are registered and compliant with FDA regulations, which include premarket notification (510(k)), premarket approval (PMA), and adherence to Good Manufacturing Practices (GMP) is essential.  

U.S. Customs and Border Protection (CBP) enforces regulations for importers which include proper classification, valuation, and marking of imported devices. Custom tariffs can impact the cost of raw materials, components, and finished products, influencing pricing strategies and market competitiveness. As the global landscape continues to evolve, it is essential to navigate the challenges and opportunities within this critical industry. 

Representative Experience

  • Successfully obtaining multiple exclusions from Section 301 tariffs on Chinese-origin goods for a large manufacturer of medical devices.
  • Advising a medical device company on compliance with CBP import regulations and FDA medical device registration requirements.
  • Obtaining favorable CBP country of origin rulings for medical devices to support non-application of Section 301 duties.
  • Conducting due diligence reviews to determine export control and sanctions risks on behalf of a non-profit medical association.

INSIGHTS

USTR Provides Detail on Products Subject to Additional Section 301 (“China”) Tariffs

By: Olga Torres, Derrick Kyle, Camille Edwards
Date: 05/22/2024

On May 22, 2024, the United States Trade Representative (“USTR”) announced the publication of a Federal Register Notice (“the FRN”) setting forth additional and increased Section 301 tariffs for specific Harmonized Tariff Schedule of the U.S. (“HTSUS”) subheadings. In addition, the FRN provides details on products subject to potential exclusions from the tariffs and establishes a period for interested parties to provide comments on the tariff modifications and potential exclusions.

Trade Alert: Section 301 Tariff Exclusion Extension Public Comment Docket Opens Today

Date: 01/22/2024

On December 26, 2023, the Office of the United States Trade Representative (“USTR”) announced the extension to May 31, 2024, of all current exclusions from Section 301 tariffs on Chinese-origin goods. The extended exclusions include 77 COVID-related exclusions and 352 previously reinstated exclusions. 

Biomedical Research – the Next Victim of a U.S.-China Trade War?

By: Derrick Kyle, Associate & Queena Leung, Law Clerk
Date: 07/17/2019

The trade dispute between the U.S. and China that started mid-2016 has no end in sight. As part of his presidential campaign, then-candidate Donald Trump threatened to apply tariffs on various imports from China. Now that he is President, these tariffs have come to fruition: after several failed rounds of trade negotiations with China, the “Section 301” probe into alleged Chinese intellectual property theft started in earnest early 2018. 

The current U.S.-China trade war does not appear to end with tariffs, however. Biomedical research appears to be the latest unlikely victim.

Recent Updates to the U.S. Cuban Sanctions

By: Olga Torres, Managing Member
Date: 07/05/2017

On June 16 2017, President Trump announced changes to the United States’ economic sanctions against Cuba. This article provides a brief synopsis of the announced changes and potential impact.