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: Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS)

CLASSIFICATION SYSTEM: Medical Devices/IVDs: I/II/III

TIMEFRAME

Standard Route: 3-6 months (excluding time to respond feedback/request from COPEFRIS). The anticipated timeline during the COVID-19 pandemic, however, has increased to 10-12 months.

Expedited Route (Third Party Route-TPR): 2-5 months (excluding time to respond feedback/request from COPEFRIS).

Equivalency Route (Applicable for all medical devices approved in the US, Canada, and Japan): 3-8 months (excluding time to respond feedback/request from COPEFRIS).

Specific Route for certain Class I (Low-Risk Medical Devices) products: 1-3 months.

SPECIAL REQUIREMENT: Testing performed outside of Mexico according to International standards is accepted, however, for some devices such as condoms, x-ray /radiation equipment, HIV/HCV/HPV test kits, and the surface antigen of Hepatitis B, in-country testing is required before submitting the registration to COFEPRIS.

Local clinical trial is not required because Clinical data from countries outside of Mexico is generally acceptable. For the US and Canada equivalency route, summaries of clinical data are acceptable. While for the Japan equivalency route, clinical data is not required.

LOCAL FEES:

Standard/Equivalency Route:

Class I – USD 630

Class II – USD 920

Class III – USD 1170

Expedited Route:

Fees vary from USD 2935 – USD 5870 as it set by the third party and depending on the device classification.

LOCAL FEES (Manufacturer): No manufacturer review fees are required.

LICENSE VALIDITY: Medical device registrations are valid for five years. renewals must be submitted under the same route as the original registration, no later than 150 calendar days before the expiration date.

LICENSE TRANSFERLicense transfers are possible in Mexico. The procedure for the transfer of rights will follow what is established for the modifications to the registration conditions.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: Foreign manufacturers without a location in Mexico must appoint a License Holder (LH) authorized by the COFEPRIS through an “Operation Notice” (Aviso de Funcionamiento).

ADDITIONAL INFORMATION: In addition to registration certificate, an import permit is also required for products such as Class III and implantable devices.

Last updated on April 20, 2021.

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

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