Mexican Regulators Allow Greater Third Party Reviewer Involvement for Stalled Medical Device Applications

EMERGO SUMMARY OF KEY POINTS:

• COFEPRIS has communicated plans to expand Third Party Reviewer (TPR) access to Mexico registrations that have stalled under the standard premarket review system.
• TPRs may obtain stalled COFEPRIS premarket registrations, review them and then submit them back to the regulator for final approval.
• The new allowance covers standard-route registrations, modifications and renewals, but excludes applications submitted under Mexico’s equivalency registration route.

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.