Case Study 90 : Registration of COVID-19 Test Kits in Mexico

Company Situation

The client is a Korean medical company that developed COVID-19 test kits and was looking for a partner to help them enter the Mexican market. Client was looking for local partner in Mexico who can register covid-19 test kits with cofepris, do the importation to Mexico and sell them in Mexico to hospitals. Client was also looking for a local representative in Mexico.

GRP Solution

With local offices in Mexico and local team of regulatory affairs professionals, GRP was appointed the local representative of the company in Mexico. GRP team was able to determine the classification of covid-19 test kits in Mexico and define the regulatory requirements and timelines for their registration in Mexico according to Cofepris regulations. Due to the current pandemic situation in Mexico, GRP regulatory team was able to negotiate with Cofepris, a faster way to register covid-19 test kits in Mexico. Because they were serology test kits, they were registered in 30 days with Cofepris, And the company was able to import them to the country and sell them to hospitals within 60 days.
Covid-19 test kits were registered within 30 days instead of 6 months.

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Mexico's Cofepris

COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios is a decentralized and autonomous body run by a commissioner appointed by the President of Mexico and regulates health facilities, advertising activities, and the manufacturing, import, or export of health products.