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Mexico Holding Services guide

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Regulatory Affairs in Mexico guide

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types of patient monitoring system
Mexico

Classification and Grouping of Patient Monitoring Systems in Mexico

Patient monitoring systems nowadays offer an ample array of healthcare solutions. From clinical healthcare to personal use, healthcare monitors evolve …

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mexican mouthwash
Mexico

Classification and grouping of Mouthwashes as a Medical Device in Mexico

As discussed in our Classification and Grouping Ultimate Guide,┬áthe first step on classifying a product is to determine if it …

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software as a medical device classification
Mexico

Classification of Software as a Medical Device in Mexico

As previously discussed in our article for Software as a Medical Device (SaMD), a significant development has occurred in the …

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Mexico

Authorization for the Acquisition and Transfer of Ionized Radiation Sources in Mexico

In Mexico, when registering medical devices related to Ionized Radiation Sources, there is a special subset of documents to be …

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fda certificate to foreign government
Mexico

Certificate to Foreign Government for Device Not Exported from the United States

As mentioned in our article about the Equivalency Agreement and our Ultimate Guide for Regulatory Affairs in Mexico, one of …

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mexican 61010 vs mexican 60601
Mexico

Electrical Testing Standards for medical electrical equipment and its use in Mexico

In a previous article, we have reviewed the regulations for medical electrical equipment (MEE) in Mexico and mentioned the cases …

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