By Stewart Eisenhart, Emergo Group
Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.
At a recent webinar sponsored by the US Department of Commerce, COFEPRIS officials addressed the issue of when COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.
The FDA issues EIRs to manufacturers after successful quality management system inspections to verify compliance with FDA Quality System Regulations (FDA QSR). Such inspections occur on an unannounced basis, however, so manufacturers cannot schedule their FDA QSR inspections or predict accurately when they can obtain EIRs. This issue can cause confusion for companies whose devices are legally registered for sale in the US but whose quality systems have not yet undergone FDA QSR inspection – how can these companies take advantage of expedited COFEPRIS review without EIR documentation?
During the US Commerce Department webinar, COFEPRIS officials explained that the Mexican regulator will accept proof of ISO 13485 certifications instead of EIRs for manufacturers that have not yet been inspected for FDA QSR compliance, or for manufacturers that have been inspected but are still awaiting issuance of their EIRs from the FDA.
COFEPRIS officials also noted that they have access to an FDA database, COMSTAT, which monitors and reviews EIRS; Mexican regulators can thus independently verify whether an applicant for expedited review has been issued an EIR or not. In cases where the COFEPRIS registrant has been issued an EIR from the FDA, ISO 13485 certification will not be accepted by Mexican regulators.
In cases where COFEPRIS registrants do submit ISO 13485 certifications in lieu of EIRs, registrants must include letters in their application materials explaining why they cannot submit EIRs.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.