Medical Device Manufacturing in Mexico: High Quality at a Lower Cost
Over the years, Baja California has become a world leader in medical device manufacturing, with facilities that are FDA, CE, and ISO 13485 certified and have clean rooms from class 100 to 100,000. Medical device manufacturing companies in Mexico produce FDA Class I, II, and III products—which are subject to the same safety regulations as those manufactured in the U.S.
Furthermore, new provisions per the USMCA focus on patent and intellectual property protection as well as streamlining processes for medical device production. Due to the intense regulatory requirements and changing legal provisions, the majority of foreign manufacturers find it beneficial to work with a shelter company. A shelter provides regulatory compliance measures to keep companies protected and in line with federal and local laws and safety processes and procedures.
This unique partnership allows companies to focus on production growth and strategy while delegating administrative responsibilities to shelter experts. A shelter also helps U.S. and other foreign companies save on manufacturing costs including labor, and transportation. Plus, under the shelter umbrella, companies benefit from IMMEX certification, which exempts them from the 16% value-added tax on all temporarily imported goods, machinery, and materials.
As a result, medical device manufacturing in Mexico continues to be one of the leading sectors, and companies around the world continue to pursue shelter solutions to expand their reach and meet rising economic demand in a competitive market.