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Mexico

Sanitary registration modifications in Mexico

  If you have an approved medical device sanitary registration in Mexico, it is important to consider that any modification …

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Mexico

New Cofepris submission guide

  Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in …

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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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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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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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