Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the CFDA only makes these available in Chinese.
Mexican Regulators Clarify Stance on Importation of Medical Devices during Renewal Periods
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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.”
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