COFEPRIS Approval in Mexico

On June 11th, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) of Mexico issued an approval for the Edinburgh Genetics COVID-19 Immunoassay Antibodies Testing Kits, a high precision, rapid diagnostic test that enables the qualitative detection of novel coronavirus 2019-nCoV IgM/IgG antibodies.

After a rigorous evaluation process involving 1,500 samples, COFEPRIS selected Edinburgh Genetics amongst the first nine approved test manufactures. This authorisation grants us the right to import and distribute our product in Mexico. 

The regulatory health agency established a protocol to assess the serological tests for COVID-19 in collaboration with the National Institute of Nutrition and Medical Sciences ‘Salvador Zubirán’ and TecSalud of the Tecnológico de Monterry. 

The COFEPRIS assessment consists of nine steps that evaluates the sensitivity, specificity, and performance of the test. After an initial selection process, a permit of importation is requested, then test samples enter the protocol. Once approved, the COFEPRIS issues an authorisation for sanitary registration that allows the import and marketing of testing kits in Mexico. 

Alasdair Young, Director: ‘We are pleased that Edinburgh Genetics is among the first serological testing products available in Mexico. We are confident that our UK-made products will provide reliable and cost-effective coronavirus testing in Mexico.’ 

For the official COFEPRIS list, please see:  https://www.gob.mx/cofepris/acciones-y-programas/comunicado-relativo-a-pruebas-serologicas-para-sars-cov2-covid-19