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sanitary registration holder in mexico

Mexico Holding Services guide

Classification and Grouping guide

Regulatory Affairs in Mexico guide

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Medical Device Regulatory Overview
Mexico

Medical Device Regulatory Overview (Mexico)

Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative …

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sanitary import permit
import permit

Import permits for Medical Devices in Mexico

  In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is …

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lista de terceros autorizados cofepris
Mexico

What is a Third Party Reviewer for Medical Devices?

  A third party reviewer (TPR) is a company authorized by COFEPRIS to review and issue an opinion regarding the …

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gmp leitfaden
GMP

Good Manufacturing Practices Guide for Mexico

  Last March the 6th, COFEPRIS updated its Good Manufacturing Practices (GMP) guide. This guide describes the criteria to evaluate …

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mexican fda
Equivalency Agreement

Equivalency Agreement summary

  Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry …

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