Proposed Changes to Regulatory Approval Process in Mexico
On August 17, 2010, Mexico's President Felipe Calderon announced changes that will affect registration of medical devices in Mexico. According to the statement issued by President Calderon, COFEPRIS (the agency that oversees medical device registration and surveillance in Mexico) will recognize devices cleared for sale by the US FDA or Health Canada in order to promote medical device imports into Mexico.
It is very important to mention that this was a presidential report and nothing specific has yet been written into law, simply an inexplicit modification to the law, in Article 161bis, which states:
ARTICLE 161 Bis. The Ministry of Health can issue general dispositions in order to recognize that the requisites, tests, evaluation procedures and other requirements requested by the foreign sanitary authorities in order to allow in their respective countries the sales, distribution and use of health supplies referred to in this regulation, are equivalent to those that the law, the present regulation and other applicable dispositions use to guarantee the quality, security and efficacy that these health supplies must comply with in order to obtain a sanitary registration in the country (Mexico).
Some speculate that only Class I devices will be included in the reform. However, these are unofficial reports and no classes of medical devices were named in the presidential report. It is possible that Class II, and III devices could also be included.
We have been advised by a COFEPRIS official that COFEPRIS expects to make an announcement in 1-2 months at which time they will announce how this will be administered. We will continue to keep you updated as we learn more about these proposed changes and when they will be implemented.