Medical Device Registration and Approval in Mexico

General country-specific regulatory information is provided on this page for medical device registration and approval in Mexico. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Mexico, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Mexico

REGULATORY AUTHORITY: Medical devices are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).

CLASSIFICATION SYSTEM: Devices are classified into three classes based on risk.

Medical Devices: Class I, II, III.

IVD Devices: Class I, II, III.

TIMEFRAME: The approval process timeframe varies depending on the registration pathway.

Medical Devices: 

Regular Process: Class I, II and III: 210-365 days

Fast-Track: Class I, II and III: 180-240days

Third Party: Class I, II and III: 60-120 days

If the MoH makes an official request for additional information, the times are reset.

IVD Devices:

Regular Process: Class I, II and III: 210-365 days

Fast-Track: Class I, II and III: 180-240days

Third Party: Class I, II and III: 60-120 days

If the MoH makes an official request for additional information, the times are reset.

SPECIAL REQUIREMENTS:

Audits: There are no audit requirements.

Technical Local Tests: There are no local test requirements.

Clinical Evaluation/studies: There are no clinical evaluation requirements.

LOCAL FEES:

Application review fees:

Class I MD/IVD: $650 USD

Class II MD/IVD: $1 000 USD

Class III MD/IVD: $1 250 USD

Manufacturer registration: There are no manufacturer review fees.

LICENSE VALIDITY: Licenses issued in Mexico expire after five years.

LICENSE TRANSFER: License transfers are possible in Mexico.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required, this must be a local company authorized by COFEPRIS.

ADDITIONAL INFORMATION: The licensing process is expedited for devices which have already been approved in the USA, Canada or Japan. The regular registration time frames have been displayed above, however, due to the current change in government in Mexico, COFEPRIS is experiencing huge delays. All of the timelines are affected with the exception of the Third Party Pathway. It is unclear how long these delays will last.

Last updated on April 16, 2019.

For more information on Medical Device Registration in Mexico, check out the following articles:

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