How to register medical devices and IVDs in Mexico
Since September 2025, COFEPRIS's new Abbreviated Pathway has opened a faster, more accessible route to market for manufacturers who already hold approvals from major regulatory bodies like the FDA, CE, Health Canada, and others. Instead of navigating a lengthy full technical review, you can now leverage your existing approvals to dramatically cut submission time and complexity. This guide breaks down everything you need to know — from eligibility requirements and device classification to documentation, timelines, and how to appoint a Mexico Registration Holder.
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