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Mexico Medical Device Registration Fees

COFEPRIS government fees for 2026

MXN 16,499

Low Risk Min

MXN 30,798

High Risk Max

COFEPRIS

Authority

2026-01-12

Last Updated

Mexico (COFEPRIS) Fee Overview

Mexico (COFEPRIS) charges per-product registration fees ranging from MXN 16,499 (~$800) for Class I to MXN 30,798 (~$1,500) for Class III. These are one-time fees - registrations are valid for 5 years with renewal fees of MXN 12,374-23,098. A Mexico Registration Holder (MRH) is required for foreign manufacturers and typically costs $2,000-$5,000/year additionally.

Complete Fee Breakdown

Fee Item	Amount	Frequency
New Registration - Class I & I Low Risk	MXN 16,499	One-time per product
New Registration - Class II	MXN 24,198	One-time per product
New Registration - Class III	MXN 30,798	One-time per product
Renewal - Class I & I Low Risk	MXN 12,374	Every 5 years
Renewal - Class II	MXN 18,149	Every 5 years
Renewal - Class III	MXN 23,098	Every 5 years