Medical Device Registration and Approval 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 5 years. renewals must be submitted under the same route as the original registration, no later than 150 calendar days before the expiration date.

As of end of December 2021, medical device registration certificate will be valid for 5 years for the initial approval and first renewal, and then becomes indefinite at the second renewal.

As of mid-December 2021, an initial product registration license will be issued with 5 years validity and it will become indefinite (no expiry date) after the first renewal, however, license must still be renewed every 5 years.

For the second renewal and forward, only notification is required unless there are product safety issues which requires product change and/or COPEFRIS requests more technical documents to be submitted.

Renewals must be submitted under the same route as the original registration, no later than 270 calendar days before the expiration date.

LICENSE TRANSFER:

License 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).

Other North American Countries: Canada, United States of America