{"id":3672,"date":"2024-07-01T22:16:08","date_gmt":"2024-07-01T22:16:08","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3672"},"modified":"2025-11-28T18:27:44","modified_gmt":"2025-11-28T18:27:44","slug":"understanding-cofepris-fees-for-medical-device-registrations-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/understanding-cofepris-fees-for-medical-device-registrations-in-mexico\/","title":{"rendered":"Understanding COFEPRIS Fees for Medical Device Registrations in Mexico"},"content":{"rendered":"

Entering the Mexican medical device market requires planning regulatory approvals and associated costs. A key aspect is understanding the fees charged by COFEPRIS and how the Marketing Authorization Holder (MHA)<\/a> must cover them. This article breaks down those topics and outline important considerations for 2024.<\/p>\n

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Legal Basis for Fees:<\/strong><\/h4>\n

COFEPRIS fees are established in the Federal Law of Fees<\/a> and updated annually. The 2024 fees for medical device registrations (rounded) are as follows:<\/p>\n

 <\/p>\n\n\n\n\n\n\n
Type of submission<\/strong><\/td>\nClass I (MXN)<\/strong><\/td>\nClass II (MXN)<\/strong><\/td>\nClass III (MXN)<\/strong><\/td>\n<\/tr>\n
New Registration<\/strong><\/td>\n15,206<\/td>\n22,302<\/td>\n28,384<\/td>\n<\/tr>\n
Renewal<\/strong><\/a>\/Technical <\/strong>Amendment<\/strong><\/a><\/td>\n11,404<\/td>\n16,726<\/td>\n21,288<\/td>\n<\/tr>\n
Administrative <\/strong>Amendment<\/strong><\/a><\/td>\n7,603<\/td>\n11,151<\/td>\n14,192<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

For convenience, COFEPRIS publishes an annual document summarizing these fees.<\/p>\n

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Payment Process:<\/strong><\/h4>\n
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  1. Payment in Advance:<\/strong> All fees must be paid before submitting any request.<\/li>\n
  2. Authorized Mexican Bank:<\/strong> Use any authorized Mexican bank<\/a>.<\/li>\n
  3. Required Information on Receipt:<\/strong>\n