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Medicines, medical devices and health products in Mexico: sanitary registration and COFEPRIS fees

Last verified: 2026-10-26 · Status: Stable

Medicines, controlled substances, medical devices other than low risk ones, pesticides, plant nutrients and toxic substances need a sanitary registration from the health ministry, issued through COFEPRIS, before they can be sold in Mexico. A registration lasts 5 years and can be renewed for 10 year periods; failing to request renewal in time, or changing the product or the raw material maker without approval, leads to cancellation. Medicine registrations require prior verification of good manufacturing practices by the health ministry itself, and the 2026 registration duty is MXN 111,012 for a generic and MXN 198,496 for a new molecule.

USD conversions use MXN 18.6638 per US dollar, the US Federal Reserve H.10 noon buying rate in New York for 23 October 2026 (FRED series DEXMXUS), the latest observation available when this page was verified. Legal conversions in Mexico use the Banxico FIX, which differs slightly. Conversions are for orientation only. Fines set in UMA use the 2026 daily UMA of MXN 117.31 published by INEGI in the DOF of 9 January 2026.

Key facts

Initial term of a sanitary registration	5 yearsLGS art. 376, as of 2026-10-26 · in force
Renewal period of a sanitary registration	10 yearsLGS art. 376, as of 2026-10-26 · in force
Registration duty for a new molecule medicine, 2026	198496 MXNLFD art. 195-A, section I b), as of 2026-10-26 · in force
Registration duty for a generic medicine, 2026	111012 MXNLFD art. 195-A, section I a), as of 2026-10-26 · in force

The rule

1. Who needs registration. Medicines, narcotics, psychotropic substances and products containing them, medical devices (except those classed as low risk that the authority exempts), pesticides, plant nutrients and toxic or hazardous substances require a sanitary registration granted only by the health ministry. The registration lasts 5 years and may be renewed for 10 year periods on request. If renewal is not requested within the set period, or the product or raw material manufacturer is changed without prior authorization, COFEPRIS cancels the registration.
Cost to do it: Registration duties per product in 2026 (LFD art. 195-A): see the table.
Example: A medicine registered in 2026 must be renewed by 2031; renewals then run for 10 years. / No currency amount for the term itself.Ley General de Salud, DOF 7 February 1984, last reform DOF 15 January 2026, Arts. 368 to 371 and 376, 2026-01-15 official text · verified 2026-10-26

2. Medicine approval standard. The ministry approves a medicine only when its safety, efficacy and quality, and those of its production process and substances, are shown. Before registration it verifies good manufacturing practices and certification of active ingredients itself; third parties cannot do these inspections, though a certificate from the country of origin can be recognized where a mutual recognition agreement exists. After registration, pharmacovigilance is mandatory. Biosimilars (biocomparables) must present the clinical and in vitro studies needed to show safety, efficacy and quality against the reference biologic. A registration holder cannot hold two registrations with the same active ingredient, dosage form or formulation, except one for the generics market.
Cost to do it: Budget for the GMP inspection of foreign plants, which the ministry must perform unless a recognition agreement applies.
Example: A German maker of an injectable must host a Mexican health ministry GMP inspection at its plant before the registration is issued, unless a recognition agreement covers the German certificate. / No statutory amount for the inspection itself.Ley General de Salud, last reform DOF 15 January 2026, Arts. 222, 222 Bis and 376 Bis, 2026-01-15 official text · verified 2026-10-26

3. 2026 registration duties. The sanitary risk duty for each registration request is: generic allopathic medicine MXN 111,012; new molecule MXN 198,496; homeopathic, herbal and vitamin products MXN 26,398; medical devices class I MXN 16,499, class II MXN 24,198 and class III MXN 30,798; pesticides by toxicological category from MXN 11,952 to MXN 110,203.
Cost to do it: New molecule MXN 198,496 (about USD 10,635); generic MXN 111,012 (about USD 5,948).
Example: A company registering one new molecule and two generics pays MXN 420,520 in 2026. / About USD 22,531.Ley Federal de Derechos, last reform DOF 7 November 2025; Resolución Miscelánea Fiscal 2026, Annex 4, DOF 28 December 2025, LFD art. 195-A, sections I to IV, 2025-12-28 official text · verified 2026-10-26

Product	MXN	USD equivalent
Generic allopathic medicine	111,012	5,948
New molecule medicine	198,496	10,635
Homeopathic, herbal or vitamin product	26,398	1,414
Medical device class I	16,499	884
Medical device class II	24,198	1,297
Medical device class III	30,798	1,650
Pesticide, toxicological category 1	110,203	5,905

2026 sanitary registration duties (LFD art. 195-A, RMF 2026 Annex 4, rounded payable amounts).

Worked example

A US medtech company launching a class II infusion pump and a class III implant in Mexico pays MXN 54,996 (about USD 2,947) in 2026 registration duties through its Mexican registration holder, and diaries renewals five years after issue.

Step by step

1. Classify each product (medicine, biologic, device class, pesticide).
2. Appoint a Mexican registration holder and prepare the dossier with safety, efficacy and quality data.
3. Pay the LFD art. 195-A duty and file with COFEPRIS; schedule the GMP inspection for medicines.
4. Set up pharmacovigilance after approval.
5. Request renewal within the period set by the regulations before the fifth year ends.

Common traps

Changing the active ingredient supplier without prior authorization: cancellation (LGS art. 376).
Missing the renewal request period: cancellation (LGS art. 376).

Sources

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