Guides

Guides

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Mexico Holding Services guide

Classification and Grouping guide

Regulatory Affairs in Mexico guide

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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

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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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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