COFEPRIS · Americas

Mexico medical device regulatory resources

Every Mexico dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

21,654 registration records12 free resources25/25 requirements covered7 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official COFEPRIS device registration records.

COFEPRIS medical device registration form filler

Paste applicant, product, and manufacturer facts and download a preliminary filled copy of the current official Word form.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official COFEPRIS regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current COFEPRIS application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely COFEPRIS pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent COFEPRIS policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Mexico requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 48 source-linked facts →

25 of 25 research dimensions currently covered · 20 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the decentralized organ of the Secretaría de Salud, exercises federal regulation, control, surveillance and health…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Current LGS text and recent reform dates: The Ley General de Salud consolidated text in force carries latest reforms of DOF 15 01 2026; Art. 376 (registration) was reformed DOF 10 05 2023 and 15 01 2026, and Art. 262 (device defini…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

Statutory device definition: LGS Art. 262 defines dispositivos médicos through seven categories: (I) equipo médico; (II) prótesis, órtesis y ayudas funcionales; (III) agentes de diagnóstico; (IV) insumos de uso odontol…
IVD coverage as agentes de diagnóstico: IVD products are regulated as 'agentes de diagnóstico', a medical device category covering antigens, antibodies, calibrators, verifiers, reagents, reagent kits, culture and contrast media a…

3 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through III.: Class I, Class II, Class III

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Registration requirement: All medical device categories (equipos médicos, prótesis, órtesis, ayudas funcionales, agentes de diagnóstico, insumos odontológicos, material quirúrgico y de curación, productos higiénicos…
Market-access routes: ordinary: Class based registro sanitario filed on official format (national manufacture: RIS Art. 179; foreign manufacture adds RIS Art. 180 documents) · low risk simplified: Annex 1 of the…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Reference regulators for the abreviada route: For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Devic…
MDSAP GMP certificate recognition: target: geo:mex · sourceApproval: GMP certificate issued under MDSAP full membership / recognized national regulatory agency · edgeType: qms audit reliance · marketAccessStrength: evidence…

6 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Local market-entry role: archetype: marketing authorization holder or registrant · name: Titular del registro sanitario (Mexican registration holder) · required for foreign: yes · registration relation: To hold a d…
Registration holder transfer (cesión de derechos): Assignment of rights over a registration must be communicated in writing to the Secretaría by the new holder within no more than 30 working days of the assignment, attaching the assignment…

2 source-linked facts

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Establishment notice (aviso de funcionamiento): Establishments that do not require a sanitary licence must file an aviso de funcionamiento with the Secretaría de Salud (or state governments) at least 30 days before starting operations; f…
Prior sanitary import permit: Importing device inputs requires a prior sanitary import authorization; products requiring it that enter without the permit are deemed illegally introduced, triggering safety measures and s…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Registration dossier (national manufacture): RIS Art. 179 requires, with the official format application: (I) scientific/technical information demonstrating safety and efficacy; (II) Spanish language label draft per the applicable NOM…
Foreign-manufacturer additional documents: For foreign made devices, the application additionally requires: (I) certificate of free sale or equivalent issued by the health authority of the country of origin; (II) manufacturer's repr…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Electronic filing portal: COFEPRIS trámites (including device registration, prórroga and clinical protocol applications) are filed electronically on DIGIPRIS Regulación en Línea (digiprisregulacionenlinea.cofepris.g…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Label, IFU, and submission language: label ifu: Sanitary information on labels and IFUs must be expressed in Spanish (NOM 137 SSA1 2025 point 5.1); other languages may be added at equal typographic size without contradicting t…
NOM-137-SSA1-2025 transition: NOM 137 SSA1 2025 (device labeling) repeals NOM 137 SSA1 2008 and enters into force 360 natural days after its DOF publication; devices whose labeling cannot be modified in time have 180 na…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS and audit evidence for market access: local regime: NOM 241 SSA1 2025 (Buenas prácticas de fabricación de dispositivos médicos) is the mandatory GMP standard for all establishments manufacturing devices and for warehouses of ac…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Verified

COFEPRIS electrical/EMC evidence: Electrical safety
IFT Homologation Type A: Wireless / radio
IFT Homologation Type B: Wireless / radio

6 maintained overlays · 2 related facts

Checked 2026-08-29

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D14

Fees

Verified

Initial registration - Class I (LFD Art. 195-A III): MXN 16,498.70
Initial registration - Class II (LFD Art. 195-A III): MXN 24,198.08

14 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Verified

Class I · Libre de Venta (LR) or Registration: 30 days
Class II · Registration or Equivalency: 35 days
Class III · Registration or Equivalency: 60 days

3 maintained pathways · 3 related facts

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Authorization duration: type: fixed term · description: Initial sanitary registration is valid 5 years and may be extended (prórroga) upon request for 10 year periods per LGS Art. 376 (paragraph introduced by the…
Renewal or maintenance: Renewal is by prórroga filed 150 natural days before expiry (first prórroga; later prórrogas every five years, same 150 day lead time). The acknowledgment receipt for later prórroga applica…

2 source-linked facts

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

Change-control outcomes: outcomes: prior approval amendment or variation; new registration or new application · description: Any modification to registered conditions of Capítulo IX devices requires prior authoriza…
New-application triggers: New models of an already registered device line from the same manufacturer with technological advances (RIS Art. 84); Changes to registered conditions outside the modification scope, includ…

2 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

Public registration database: COFEPRIS publishes the Visor de Registros Sanitarios de Dispositivos Médicos (live from 20 08 2026) at registros.cofepris.gob.mx/BRSDM/default2.aspx, giving the public and health institutio…
Registration key on labeling: On granting a registration, the Secretaría assigns each device an alphanumeric key with the letters SSA, which the registration holder must express on product labeling as the applicable NOM…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation authorization: Human subject research that includes administering a medicine/biological or using a medical device requires prior COFEPRIS authorization of the investigation protocol (trámite COFEPRIS 04 0…
Import of unregistered devices for research/registration: The Secretaría may grant import permits for raw materials or finished products WITHOUT sanitary registration only for: (I) contingency; (II) health policy needs; (III) scientific research,…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exception letters under the low-risk lists: Holders of oficios de excepción affected by the July 2025 low risk Acuerdo have a maximum of three years to obtain registration where required, in staggered windows (items 1 38 in 2025 2026…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Lifecycle traceability duties under NOM-241-SSA1-2025: Under the mandatory device GMP norm, manufacturers must maintain documented methods to ensure traceability of design and development inputs and outputs, and production records traceable to…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Adverse-reaction notification duty: Adverse reactions of medicines or other insumos (including devices) arising during commercialization or use, notified by health professionals, published in scientific literature, or reporte…
Notification channels and format: Adverse incident notifications are submitted through the Sistema de Notificación en Línea de Incidentes Adversos de Dispositivos Médicos to the Dirección Ejecutiva de Farmacopea y Farmacovi…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Recall-related powers and notifications: Sanitary safety measures under LGS Art. 404 include seizure and destruction of objects, products or substances and suspension of advertising messages; suspension of production or commercial…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising authorization requirement: Advertising on the existence, quality and characteristics, or promoting the use, sale or consumption directly or indirectly, of insumos para la salud (which include devices) is subject to a…
Medical media promotional notice: Catalogs of device insumos and promotional information in medical journals or print directed at health professionals are medios de difusión médica; the company responsible for such publicat…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Deficiency notices and deemed decisions: Deficiency requests (prevención) in COFEPRIS trámites, and the applicant's deadline to cure them, are governed by Article 17 A, second paragraph, of the Ley Federal de Procedimiento Adminis…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (14 lines) →

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

10 more fee lines on the full schedule · 14 of 14 rows source-verified

Registration timeline

Full registration timeline →

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)	30 days	3 months	Verified
Class II(Registration or Equivalency)	35 days	1.3-2.6 years	Verified
Class III(Registration or Equivalency)	60 days	1.3-2.6 years	Verified