Regulatory Authority
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).
Classification
I, II, III
Quality system
ISO 13485:2016
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
Medical Devices are subject to registration.
Manufacturers without local presence in Mexico must appoint a Local Authorized Representative (Mexico Registration Holder)
Applicant
Local Authorized Representative (Mexico Registration holder).
Timeframe and fees
Timeframe: 4-12 months.
Costs may vary depending on the device class.
Labelling and documentation language
Documentation and labelling must be provided in Spanish.
