EMERGO SUMMARY OF KEY POINTS:

• Mexican regulators now allow drug registrants to submit product modification and renewal applications simultaneously.
• It is anticipated that COFEPRIS will eventually extend this allowance to medical device registrants.
• If extended to medical devices, the COFEPRIS allowance would streamline manufacturers’ obligations in order to obtain registration renewals and approvals for product changes.

Recent changes to modification and renewal requirements for drug registrations in Mexico may soon apply to medical devices, as well.

Mexico’s medical device and pharmaceutical regulator COFEPRIS has published new allowances for drug applications to combine product modifications and renewals. Rather than have to submit modifications such as change of manufacturing site, change of commercial name, change of registration holder or change of therapeutic indication separately to COFEPRIS, drug manufacturers may now submit changes simultaneously with applications to renew their product registrations.

Will COFEPRIS allow renewal-modification combinations for medical devices?

Emergo consultants in Mexico City report that although such allowances have yet to be published for medical devices in Mexico’s official diary, COFEPRIS typically applies new rules and allowances first to drugs and then a few months later to devices.

If COFEPRIS does eventually extend this renewal-modification combination allowance to medical device registrants, manufacturers stand to benefit by no longer having to make separate submissions to—and await separate approvals from—the regulator.

For more information on Mexico’s medical device registration process, download our regulatory process chart and read our whitepaper.