May 23, 2014
Mexico’s medical device market regulator COFEPRIS has officially notified the country’s Custom officers to allow importation of medical devices whose registration renewal applications are still being processed.
According to Emergo’s Mexico City office, COFEPRIS will allow importation of medical devices if manufacturers have submitted their registration renewal applications on time (150 days prior to registration expiration date) and have yet to receive responses from the regulator.
“This allowance by COFEPRIS will be useful for those firms that submitted their extension applications on time but have not received responses after 150 days,” says Miguel Torres Tello, Business Development Manager of Emergo Group’s Mexico operations.
He cautions, however, that the COFEPRIS notice has not yet been approved by Mexican customs authorities—that means that certain customs brokers may keep asking for valid COFEPRIS sanitary registrations for the time being.
“Nevertheless, this new COFEPRIS document should provide strong support for medical device importers who’ve complied with what is stated in Mexican law.”
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.
On October 26, 2010 COFEPRIS (the Federal Commission for Protection against Sanitary Risks, of the Mexican Health Authority) officially announced the equivalence agreement to be applied to medical
Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in th