The USMCA Agreement

by | Apr 29, 2021 | Exports, FDA, Harmonization, Medical Devices

FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into force on July 1st, 2020, and focuses on harmonizing regulations, ensuring better quality products are available to American Consumers and levels the playing field for American Businesses in North America. This agreement supersedes the 25-year-old North American Free Trade Agreement (NAFTA).1

As part of this agreement, FDA focuses on:1

  • Requiring parties to accredit or otherwise recognize U.S. testing and certification bodies for medical devices, pharma, cosmetics, biologics food, and other FDA-regulated products.
  • Encourages cooperation among the parties in an international forum like the IMDRF
  • Endorses the Medical Device Single Audit Program, in which the US and Canada are members, but not Mexico.
  • Require that market authorization procedures for products be transparent, predictable, and science-based across North America
  • Assess Canada and Mexico’s ability to protect trade secret information and evaluate the feasibility of exchanging confidential information on inspections.
  • Encourages avoiding duplicative regulatory requirements and applying a risk-based approach to regulating the safety of products
  • A provision for good regulatory practices (GRPs)

GRPs cover international processes and policies that improve the quality and cost-efficiency of local regulations. This chapter was not included in the NAFTA but has tremendous potential to reduce the burden on the industry to comply with duplicative or divergent regulatory requirements. This chapter provides an opportunity for regulators in the US, Mexico, and Canada to benefit from each other’s scientific and technical expertise.1

I am sure that the implementation of this agreement will bring more harmony and alignment within the regulatory framework in North America. Whatever the changes are, know that EMMA International is here to assist you with all your compliance needs, call us today at 248-987-4497 or email us at info@emmainternational.com to learn more.


1 FDA (Nov 2020) Why the United States-Mexico-Canada Agreement is Important to FDA retrieved on 04/21/2021 from https://www.fda.gov/news-events/fda-voices/why-united-states-mexico-canada-agreement-important-fda

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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