How to register a medical device with COFEPRIS in Mexico

This video provides a clear, practical explanation of the medical device registration process in Mexico, from initial classification to final market approval. Whether you're an established manufacturer entering a new market or a startup exploring international expansion, understanding how to work with COFEPRIS (the Federal Commission for the Protection against Sanitary Risk) is essential. We outline every major step, regulatory requirement, and strategic opportunity for manufacturers looking to access one of Latin America’s most dynamic and high-potential medtech markets.

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Mexico represents a powerful opportunity for global device manufacturers. With a population of over 125 million, increasing healthcare investments, and rising demand for high-quality imported medical devices, the market is valued at $12.6 billion and is expected to grow steadily at 7.6% CAGR through 2029. COFEPRIS plays a central role in determining how quickly and efficiently foreign manufacturers can bring their products to market. But while its processes are defined, they are far from simple. Navigating them successfully requires precision, planning, and local expertise.

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Topics covered in the video include:

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• Mexico's Medical Device Market Overview:
  Key statistics on market size, growth trends, and why Mexico is a strategic target for global medtech companies.
• Regulatory Landscape in Mexico:
  An introduction to COFEPRIS and how it governs the classification, registration, and commercialization of medical devices and IVDs.
• How to Classify Your Device:
  A breakdown of Mexico’s risk-based classification system (Class I, II, III, and low-risk list) and how it affects your registration pathway.
• How to Register a Medical Device in Mexico:
  Step-by-step overview of the full process, from appointing a local registration holder and preparing technical documentation to submission timelines and approval routes (including use of Equivalency Agreements with FDA, Health Canada, and others).
• Pure Global’s Support:
  A look at how Pure Global acts as your Mexico Registration Holder (MRH), offering end-to-end regulatory support to simplify compliance and accelerate market entry.
• Does My Product Qualify as a Medical Device?:
  Guidance on how to determine whether your product falls under Mexico’s medical device definition and what to do if it doesn’t.

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If you’re planning to enter the Mexican medtech market, this overview offers a strong foundation for navigating COFEPRIS requirements with confidence. For manufacturers ready to act, Pure Global’s team provides expert support across registration, renewals, and post-market compliance.

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