Mexico Passes Express Medical Product Registration Agreement

A new Mexican agreement offers breakthrough opportunity for pharmaceutical and medical device manufacturers looking to export to Mexico.

Mexico City, Mexico—­­On a historic day for Mexico, The Secretary of Health introduced new measures to expedite healthcare product registrations through COFEPRIS (Mexico’s FDA).  By far the most momentous change in healthcare to occur in Mexico since COFEPRIS’s creation in 2001.  And with this improved process, companies may now receive authorization to market their medicines and medical devices within five days.

“The introduction of these new measures opens the doors to many companies looking to export their products to Mexico.  With these new measures, we can import products quickly and much more affordable than in previous administrations,” said Kevin Lenahan, 2 Retrievers Executive Director.  “Mexico is by far one of the most powerful LATAM trading partners, and we have no doubt it will continue to innovate and welcomes new technologies and healthcare products at the benefit of the Mexican people.”

COFEPRIS

2 Retrievers may now register new medical products in Mexico within two weeks, five days for governmental approval and 7-9 days to prepare the registration dossier for COFEPRIS.  This is a massive improvement from the historic registrar process, where an application would sit on the government’s docket from 7-11 months on average.  The new fast-track regulations specifically recognizes the following as qualifying countries:

For Medicines: 

·      USA

·      Canada

·      Japan

For Medical Devices:

·      US

·      Canada

·      Japan

·      EU

·      South Korea

·      Australia 

With industry-leading partnerships, 2 Retrievers also delivers sales performance in a seamless process after registration, which means no matter what current sales hurdles the company is currently working to achieve, 2 Retrievers can support.  After registering the qualifying products for sale to the Mexican, 2 Retrievers can now submit proposals to the Mexican government’s purchasing cycle—now overseen by UNOPS—by the end of the procurement cycle mid-January.

When compared to the previous regulations, 2 Retrievers can:

·      Import medical products 8x faster.

·      Register medical products 36x faster.

·      For the first time, register, list, sell new products within two months.

·      Cut registration costs by ~68% for prospective manufacturers.

To read the new regulation click here.