Messico

The information on this page is valid and current as of May 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


Regulatory Authority:
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).

Classification:
I, II, III

Quality system:
ISO 13485

Procedure:
Medical Devices are subject to registration.
Manufacturers without local presence in Mexico must appoint a Local Authorized Representative (Mexico Registration Holder)

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Applicant:
Local Authorized Representative (Mexico Registration holder).

Timeframe and fees:
Timeframe: 4-12 months.
Costs may vary depending on the device class.

Labeling and documentation language:
Documentation and labelling must be provided in Spanish.

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