From the August 2012 issue of HealthCare Business News magazine

Although there continues to be delays, steps are being taken to reduce them. Much of the progress has been helped by AMID’s intercession. AMID was founded in 2007 to form a united common front in order to help authorities to improve the sector’s regulatory framework.

Another factor that has greatly contributed to the disentanglement of the delivery of registration certificates was the appointment of Mikel Arriola as COFEPRIS’ Federal Commissioner in March 2011. Within one year, he has revolutionized the way the COFEPRIS works and has greatly improved its efficiency. “With the new COFEPRIS commissioner things have improved a lot,” says Alfredo Merino, general director of Fresenius Mexico. “With the past commissioner, all sanitary registrations were kept on hold. Today, everything is moving much faster as the new commissioner is working very closely with the industry.”


The changes made have all been in line with the global harmonization task force, which aims to harmonize national medical devices’ regulatory systems around the world. The most relevant innovation has been the equivalence agreement, also known as “fast-track”, signed in October 2010 between Mexico, the U.S. and Canada, easing the registration processing of products already approved by the FDA or Health Canada. The fast-track signed in 2010 with the U.S. was decisive given the importance of U.S. companies and products in the Mexican medical devices market. “St. Jude Medical was the first company to benefit from the fast-track plan,” said Ramón Soto, general manager of St. Jude Medical in Mexico. “This first time the process took only 10 days. It constitutes a great enhancement compared to the conditions existing prior to the signing of the agreement.”

In January, those agreements were expanded to include Japan and are expected to be extended to the EU fairly soon. The new framework has drastically reduced the time necessary to get a medical device officially registered. Makoto Kato, General Director of Omron, a Japanese international company specialized in cardiologic devices, praised the benefits that will be brought by the recently signed equivalence with Japan. “Omron, as a member of the Japanese Chamber of Commerce, has been supporting COFEPRIS during the negotiations with the Japanese Health Authorities. We are very optimistic with this fast track agreement as it embodies a decisive stimulus for the growth of Omron’s business in Mexico,” he said.

International players in the Mexican market

August 2012 Magazine

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