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Medical Devices Regulatory Support in Mexico

Overview

Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, falls under the Ministry of Health (MoH) and regulates the Medical Devices marketed in Mexico. Sanitary Authorization Commission evaluates the COFEPRIS medical device registration applications, whereas Sanitary Operations Commission is responsible for auditing the warehouse and other facilities located in Mexico. 

Classification of Medical Devices

Mexico Medical Device Classification is divided into classes based on risk levels.

COFEPRIS has a list of deregulated and very low risk medical devices. The medical devices which are not included in either of these lists are classified into six families or groups - Diagnostic Agents, Medical Equipment (I.E. Accessories and Appliances), Prosthetics, Orthotics, and Functional Aids, Surgical Materials, Hygiene Devices and Dental Supplies.  

Devices falling under each of these families or groups are further classified into three classes. Mexico Medical Device Registration requirements vary with class of the device. The classification of various Medical Devices and IVDs (In Vitro Diagnostics) in Mexico is detailed below.  

Medical Device Class

Criteria

Class I

Very Low Risk

Class II

Low Risk

Class III

Medium risk

Class IV

High Risk

 

Registration of Medical Devices

Market authorizations

The medical device manufacturers may opt for any of the three medical device registration pathways available with COFEPRIS. The choice between traditional pathway, equivalence pathway, and/or Third-Party review of devices depends on the approval status of the device and urgency of device registration.  

 Sanitary Registration Pathways: 

 Notification: Class I Low risk devices do not require detailed registration process and requires submission of some basic device and company details to COFEPRIS.  

Traditional or Standard Pathway: The devices with no prior approval in the US, Canada or Japan should opt for this pathway. This pathway requires submission of detailed technical dossier of the device.

Third-Party Review Pathway: The submissions going under the traditional pathway are eligible to opt a Third-party reviewer organization for expedited Mexico medical device approval of their device registration applications. Third parties are the local Mexico based organizations authorized by COFEPRIS, to review the applications and provide pre-approval. This pre-approval helps in obtaining expedited Mexico medical device approval from COFEPRIS. Manufacturers with an urgency for market-entry at the expense of additional cost may opt for this route. Only applications under standard / traditional route are eligible for Third-Party Review. The applications under Expedited Pathways are not eligible for Third-Party Reviews. 

Expedited Pathway: The devices with prior approval in the US, Canada or Japan qualify for this registration route. This route requires the manufacturer to submit minimal details. Manufacturers may leverage reference country approvals and this pathway to reduce the translation costs. 

Product Compliance & Management

Sl. No

Validity of Registration Certificate

Renewal

Post-approval Changes (Variations)

01

05 years.

Application of renewal shall be submitted 150 days prior to expiry of the sanitary registration. However, the pathway chosen for the original sanitary registration of device determines the timelines for the renewal activities. 

Administrative and Technical modifications to the applications is allowed. License transfer is allowed in Mexico. However, the pathway chosen for the original sanitary registration of device determines the timelines for these activities. 

Freyr Expertise

  • End-to-end Mexico Medical Device Approval Services 
  • Medical Device Compliance in Mexico 
  • Sanitary Responsible Person (SRP) Services 
  • Application Submission to COFEPRIS 
  • Query Support Management till Approval 
  • Post Approval Device Life Cycle Management 
  • Import License Services 
  • Artwork Management 
  • Labeling Management 
  • Translation Services              

Location

Calle Jose Bernardo Couto 87, Colonia Mexico, Nezahualcoyotl, Estado de Mexico – CP. 57620

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