COFEPRIS market accessResearch COFEPRIS registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Mexico medical device resource.
Search official COFEPRIS device registration records.
Paste applicant, product, and manufacturer facts and download a preliminary filled copy of the current official Word form.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official COFEPRIS regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current COFEPRIS application, review, and renewal fees.
Estimate the likely COFEPRIS pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent COFEPRIS policy, guidance, and compliance updates.
Describe your device and get a preliminary COFEPRIS risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Mexico requirements.
Describe a device and find comparable products in the COFEPRIS registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Common questions about changing a registered medical device in Mexico. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 32 official sources · latest verification 2026-10-21
COFEPRIS registration fees in MXN · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Initial registration - Class I (LFD Art. 195-A III) | MXN 16,498.70 | Verified |
| Initial registration - Class II (LFD Art. 195-A III) | MXN 24,198.08 | Verified |
| Initial registration - Class III (LFD Art. 195-A III) | MXN 30,797.57 | Verified |
| Second and subsequent renewal - Class I (75%) | MXN 12,374.03 | Verified |
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) review clocks and planning ranges · 3-class (I, II, III) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class I(Libre de Venta (LR) or Registration) RIS Art. 179: Clase I resolved within 30 calendar days, with positive administrative silence (deemed approval) on lapse LR pathway and Annex 1 low-risk registrations are faster; Annex 1 items are resolved within a maximum of 20 working days (July 2025 Acuerdo) Registration/Equivalence realistic range remains 15-31mo in backlog periods | 30 days | 3 months | Verified |
| Class II(Registration or Equivalency) RIS Art. 179: Clase II resolved within 35 calendar days (15 days with a favourable Tercero Autorizado dictamen) ARR equivalence route (COFEPRIS-04-050, Lineamientos DOF 18-07-2025): maximum 30 working days Equivalency route much faster if FDA approved | 35 days | 1.3-2.6 years | Verified |
| Class III(Registration or Equivalency) RIS Art. 179: Clase III resolved within 60 calendar days (15 days with a favourable Tercero Autorizado dictamen) ARR equivalence route (COFEPRIS-04-050): maximum 30 working days Equivalency pathway best option with FDA | 60 days | 1.3-2.6 years | Verified |
Newest official COFEPRIS headlines from the daily-refreshed feed — every row links directly to the authority publication.
MexicoAug 18COCOFEPRISCOFEPRIS strengthens pharmacovigilance and technovigilance with the publication of the National Bulletin 2026-IMexicoOct 01, 25COCOFEPRISCOFEPRIS publica guía para la presentación de solicitud de reconocimiento de medicamento huérfanoMexicoSep 24, 25COCOFEPRISCOFEPRIS strengthens regulation in clinical trials with the issuance of 16 ICH efficacy guidelinesMexicoSep 24, 25COCOFEPRISCOFEPRIS fortalece la regulación en ensayos clínicos con la emisión de 16 guías de eficacia de ICHMexicoOfficial COFEPRIS rules and guidance · 21 of 21 documents linked to official sources
Computed from 21,654 official COFEPRIS registration records · data as of 2026-08-20
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Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Mexico (COFEPRIS).
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