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Revolutionising the Medical Device Industry What is Health 4.0? Health 4.0 is a concept that arises from the fourth industrial revolution, or

The Good Manufacturing Practices (GMP) Certificate is the legal document that certifies that the company manufactures its products under conditions and practices

In Mexico, Medical Devices are classified according to the risk involved in their use, for registration purposes, so we have the following

During the current administration, Cofepris has set the objective of promoting clinical research in Mexico. This subject had not received the necessary

In February of this year, Cofepris published its Regulatory Certainty Strategy focused on biosimilars with which they want to establish and make

On December 15th, 2023, Cofepris published on its internet portal the “Guide for entering information for the Registration application of pharmaceutical products”,

Experts in consulting and regulatory and pharmacovigilance intelligence in Mexico. Specialists in approvals for drugs, medical devices and other products and services within Cofepris.

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