Mexico’s COFEPRIS allows Third Party Reviewers (TPRs) to access stalled medical device registrations

The Mexican health authority COFEPRIS has started to allow Third Party Reviewers (TPRs) to access premarket registrations that have stalled under the standard review system.

After obtaining authorization from a Mexico Registration Holder (MRH), TPRs may review their registration applications and then submit them back to COFEPRIS for final approval.

The new process also covers modifications and renewals, but does not apply to registrations submitted under Mexico’s  equivalency routes based on prior market authorizations in the US, Canada or Japan.

The involvement of TPRs is expected to help speed up registration procedures and make medical device marketing in Mexico more efficient.

http://mexiko.ahk.de/fileadmin/ahk_mexiko/2016/Delegationen/Salud_2016/Cofepris.pdf