Mexico Medical Devices Regulations

Medical devices intended to be manufactured/ imported/ distributed in the region are regulated and governed by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Located in proximity to the United States and Canada, Mexico has an expedited approval process for products already having a FDA and Health Canada clearance.

Mexico Medical Device Consulting

Medical Devices Classification

COFEPRIS has defined six (06) different product classes, based on which the approval route and complexity for a product can be defined. Following the first rule, a manufacturer must classify the product into one of these six groups depending on their function and purpose:

  • Diagnostic agents
  • Medical equipment 
  • Orthotics, prosthetics and functional aids
  • Surgical materials 
  • Dental Supplies
  • Hygiene devices 

Legal Representative

Athreva can assist with device classification for products:

  • Along with a broader scope for device and IVD classification, medical devices are also categorized into three different classes - Class I, II & III depending on the intended use and the risk involved. The required documents are similar for each class; however, the time of approval and clinical requirements may vary. It becomes essential to determine the class of a device.

Registration of Medical Devices

With Athreva’s presence in Mexico, a company can aim for getting a fast and seamless market approval by-

  • Determining the classification and registration route for medical device and in-vitro diagnostic device (IVD)
  • Supporting in gap analysis of the existing technical file

Compliance and Audit

  • Support for COFEPRIS audit preparedness
  • Consultation for regional GMP requirements

Regulatory Labeling and Artwork

  • Creation of labels, IFUs, product brochures and promotional materials
  • Creation of promotional webpages and social media promotional banners
  • Assistance with local language material designing

Regulatory Strategy Consulting

  • Regulatory advice on market entry strategy
  • Support with assessing & selecting distributors

Local Responsible Person

  • Acting as a legal representative and liaising with HA
  • Incident reporting and complaint handling
  • Support for technical file submissions
  • Interaction with agency for submission and queries

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