Mexico’s COFEPRIS provides glimpse of medical device regulatory activities

By Stewart Eisenhart, Emergo Group

EMERGO SUMMARY OF KEY POINTS

• COFEPRIS plans for 2017 include expanding the list of products exempted from Mexican medical device regulations.
• The Mexican Third Party Reviewer (TPR) program is becoming a more viable market pathway for medical device registrants.
• Equivalency route approvals utilizing US, Canadian and/or Japanese registrations are also on the uptick.

Mexican medical device regulatory agency COFEPRIS recently offered updates and projections regarding its oversight activities that could help prospective Mexican market applicants anticipate how their registration processes will proceed.

Emergo consultants in Mexico City report that in a presentation (link in Spanish) on medical device industry health regulations in Mexico, COFEPRIS revealed a variety of information while discussing the country’s registration requirements:

• The regulator is currently preparing a third update that will expand its existing list (link in Spanish) of deregulated products, but provided no timeframes for when those additions will be made.
• COFEPRIS currently employs 40 staffers responsible for reviewing medical device registration submissions.
• Nearly 30,000 sanitary registrations were issued by the agency between March 2011 and September 2016, with COFEPRIS averaging 446 registrations per month during that period.
• There are 18 Third Party Reviewers (TPR) with 85 total certified reviewers operating in Mexico.
• TPRs have received more than 7,000 registration applications so far in 2016; this figure represents 18% of all applications submitted to COFEPRIS. (
• Equivalency routes whereby prior market approval by a recognized market regulator provides expedited access to Mexico have been successfully utilized for more than 3,600 registrations in Mexico so far in 2016.
  • 64% of such registrations were released through the US Food and Drug Administration
  • 33% went through Health Canada prior review
  • 27% went through the Japanese Pharmaceutical and Medical Devices Agency (PMDA).

Based on these figures released by COFEPRIS, applying for Mexican registration via TPR as opposed to directly through the regulator has appealed to a growing number of companies willing to pay more for potentially lower review timeframes. Initiatives launched by COFEPRIS in early 2016 to improve the TPR program may also be paying off in this regard.

Furthermore, equivalency routes clearly present a compelling registration option for foreign companies interested in Mexico; numbers of registration submissions via TPR and equivalency routes will no doubt increase as these options’ viability expands.

More information on Mexican registration pathways can be found on our whitepaper and in our video overview.

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.

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