Dec 5, 2016
EMERGO SUMMARY OF KEY POINTS:
COFEPRIS, Mexico’s medical device market regulator, has begun allowing Third Party Review organizations (TPRs) access to registration applications that have caused backlogs through standard registration channels in order to expedite market entry for such applicants.
Emergo consultants in Mexico City explain that under the new allowance, a Mexico Registration Holder (MRH) may authorize a TPR to search for and retrieve COFEPRIS registrations that have become “stuck” in the standard review process; the TPR may then review and pre-approve the application and then submit that application back to COFEPRIS for final approval.
The new process applies not only to new device registrations but also modifications and renewals, according to an email to Emergo from Mexican regulators. However, the new allowance does not apply to device registrations submitted via equivalency routes leveraging prior market authorizations in the US, Canada or Japan.
TPR review of COFEPRIS registration applications has proven more and more popular among Mexico market registrants, as we recently reported. Expanding the TPR option should help address review logjams at COFEPRIS and free up regulatory resources, resulting in more efficient market pathways for medical device companies.
Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.
Mexico’s medical device market regulator COFEPRIS has slated efforts to improve its third-party review (TPR) process and reduce registration timeframes for 2016.
Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance reporting program (link in Spanish) for medical device manufacturers commercialized in the country.
First announced in early 2013, the technovigilance system will support post-market device monitoring and management of adverse event reporting and corrective actions.