The Mexican Ministry of Health now has in place two new processes that will impact medical device manufacturers registered or planning to register with COFEPRIS.

First, Mexican regulators have approved good manufacturing practice requirements (page in Spanish) based on ISO 13485 criteria for all medical devices distributed in the country. These requirements will go into effect in April 2013, after which COFEPRIS will be authorized to oversee and inspect manufacturing and distribution facilities to ensure quality system compliance.

Second, the Ministry of Health has approved the installation and operation of a technovigilance system (page in Spanish) for post-market monitoring of medical devices, managing adverse event reporting and taking corrective actions when necessary to protect public safety. The new system is expected to launch in April 2013.

Once in effect, these new rules could require more effort by manufacturers to comply with medical device registration requirements in Mexico, but the market will likely remain on its high-growth trajectory.