Explore the medical device requirements currently available for Mexico, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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 publications must file the corresponding notice (aviso) with the Secretaría.
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 authorization by the Secretaría de Salud (LGS Art. 301); the regulatory provisions determine products/services for which only an aviso (notice) to the Secretaría is required (LGS Art. 301 bis). Fees are charged per product and message type (LFD Art. 195-I).
What expires, what is retained periodically, and when must renewal start?
Fixed Term
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 reforms of DOF 10-05-2023, current text DOF 15-01-2026); the RIS separately requires later prórroga filings every five years (Art. 190 Bis 7, DOF 31-05-2021).
Effective from 2023-05-11
COFEPRIS comunicado 145/2023 confirms registrations have been 5-year valid since 2005 with extensions via Digipris.
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 applications itself extends the registration, keeping the same alphanumeric key. If the application is not filed within the window, the registration loses validity and a NEW registration must be requested.
Effective from 2021-06-01
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Any modification to registered conditions of Capítulo IX devices requires prior authorization by the Secretaría with supporting technical, scientific and legal information (RIS Art. 184); distributor changes add Spanish label/counter-label drafts. New models of the same product line and manufacturer with technological advances require a NEW registration (RIS Art. 84). Authorized modifications grant up to 240 working days to exhaust existing labeling stock (RIS Art. 189, reformed DOF 31-05-2021).
Which clinical or IVD performance evidence or study is required and accepted?
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, registration purposes or personal use; (IV) laboratory testing.
Human-subject research that includes administering a medicine/biological or using a medical device requires prior COFEPRIS authorization of the investigation protocol (trámite COFEPRIS-04-010, Modalidad C 'Nuevos Recursos' covers materials, grafts, transplants, prostheses and physical, chemical or surgical procedures). The dossier includes the registered ethics-committee recognition, protocol, investigator and sponsor formats, and investigational-product GMP evidence; filed on DIGIPRIS; response time 30 natural days; 2026 fee MXN 8,196.
Legal basis per the ficha: LGS Arts. 100/102, Reglamento de la LGS en Materia de Investigación para la Salud, NOM-012-SSA3-2012.
Is the product a device, IVD, accessory, software, or borderline product locally?
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 odontológico; (V) materiales quirúrgicos y de curación; (VI) productos higiénicos; (VII) any other inputs evaluated and recognized as medical devices.
Effective from 2023-05-11
Paragraph of fraction I reformed DOF 10-05-2023; effective date approximated to day after DOF publication of the 10-05-2023 reform decree.
IVD products are regulated as 'agentes de diagnóstico', a medical-device category covering antigens, antibodies, calibrators, verifiers, reagents, reagent kits, culture and contrast media and any similar input used as an adjunct to clinical or paraclinical procedures.
COFEPRIS device-registration guidance covers medical software (Software como Dispositivo Médico, ScDM): applicants must demonstrate safety and efficacy for ScDM within the device registration dossier.
Which evidence, local deltas, formats, and signatures are required?
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 representation letter when the applicant is not the manufacturing headquarters; (III) GMP certificate issued by the health authority of the country of origin; (IV) original certificate of analysis on the manufacturer's letterhead signed by its responsible chemists.
Documents accompanying RIS applications must be drafted in Spanish or English; documents issued by foreign authorities must be apostilled or legalized, and documents in any other language must be accompanied by a translation by a certified expert translator (perito traductor with cédula profesional). Representation letters presented for import or registration must be authenticated by the applicable legal procedure.
Effective from 2021-06-01
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; (III) Spanish IFU or operation manual when applicable; (IV) manufacturing process description; (V) structure, materials, parts and functions for equipos médicos; (VI) GMP certificate (constancia de buenas prácticas de fabricación); (VII) laboratory tests verifying specifications; (VIII) bibliographic references; (IX) others set in NOMs.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Marketing Authorization Holder Or Registrant
Titular del registro sanitario (Mexican registration holder)
yes
To hold a device registration the applicant must operate a notified establishment in Mexico (fábrica/laboratorio de producción, almacén de depósito o distribución, o acondicionamiento) with aviso de funcionamiento; foreign manufacturers act through a representation letter holder.
May Be Holder Or Named Importer
May Be Holder Or Use Registration With Authorization
allowed
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 documents and duplicate Spanish label projects showing the new holder; an inscription fee applies under LFD Art. 195-K.
Effective from 2021-06-01
Which establishment licences, importer permissions, and distribution controls apply?
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; for device registration holders this notice is a holding requirement (RIS Art. 181). Device factories and warehouses are not among the establishment types requiring a full sanitary licence under LGS Art. 198 (which lists narcotics processing, medicines/plaguicidas manufacture, plaguicide application and radiation sources).
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 sanctions. The import authorization has a maximum validity of 180 days, extendable once for an equal period if conditions are unchanged. Importers must keep import authorizations for at least three years and exhibit them to the authority on request.
What regulator fee applies to this class, route, event, and date?
For modifications of the holder's name or corporate name or any other change regarding the holder of registrations under LFD Art. 195-A, the fee payable is 50% of the corresponding registration fee.
Effective from 2026-01-01 · Effective until 2026-12-31
For modifications other than holder-name changes, renewals or prórrogas of the registrations listed in LFD Art. 195-A (including device registrations), the fee payable is 75% of the corresponding registration fee.
Effective from 2026-01-01 · Effective until 2026-12-31
Distinct legal rule recorded as fact; the class-based amounts are reported as typed findings.
Which label and IFU elements, languages, symbols, and translation controls apply?
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 natural days from entry into force to exhaust existing packaging materials and finished-product stock.
Norm issued in Mexico City on 11-03-2026; exact DOF publication date not stated in the opened text, so effectiveFrom left null.
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 the Spanish text (5.7); only the distinctive name/brand may appear in another language (5.10.2); imports may carry an added Spanish counter-label applied after customs clearance (5.7.1).
Registration dossier includes the Spanish label draft and Spanish IFU/operation manual (RIS Art. 179 II-III); application documents in Spanish or English (RIS Art. 153).
Baseline fact re-verified and strengthened with the new 2025 labeling NOM and RIS Art. 179.
Which current law, regulation, guidance, and transition provisions apply?
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 definition) was reformed DOF 10-05-2023.
Effective from 2026-01-16
Reform-note lines under each article state the DOF dates verbatim.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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 operators and supervisors; NOM-241-SSA1-2025 covers manufacturing and warehouse establishments.
Effective from 2025-11-30
Which current form, portal, account, and submission package must be used?
COFEPRIS trámites (including device registration, prórroga and clinical-protocol applications) are filed electronically on DIGIPRIS Regulación en Línea (digiprisregulacionenlinea.cofepris.gob.mx) using a valid advanced electronic signature (firma electrónica avanzada); COFEPRIS communications state registrations are extended through the Digipris electronic platform.
Ficha COFEPRIS-04-010 (opened) instructs: 'Ingresar a la página oficial DIGIPRIS Regulación en línea con su firma electrónica avanzada vigente'.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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 acondicionamiento, depósito and distribution commercializing or supplying devices in Mexico; it entered into force 30-11-2025 and is partially equivalent to ISO 13485:2016.
ISO 13485 is supporting evidence; the NOM is mandatory and partially aligned with ISO 13485:2016.
GMP certificates from MDSAP full members are recognized as reference-authority evidence (Lineamientos Art. 24); the first prórroga of foreign-made device registrations requires a GMP certificate from a recognized national regulatory agency (RIS Art. 190 Bis 4 II).
Effective from 2025-11-30
Dates verified on the Secretaría de Economía Platiica record (publication 4/4/2025, entry into force 30/11/2025, cancels prior NOM-241).
Which recall, FSCA, notice, and authority-coordination duties apply?
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 commercialization of insumos must be communicated to the authority within 30 working days of occurring, stating causes, and restart within the following 10 days (RIS Art. 36); exporters must report foreign sanitary rejections of exports within 5 days with product identification, lots and cause (RIS Art. 152), and re-entry of rejected goods requires an import permit.
Which registration, notification, listing, reliance, or conformity route applies?
Annex 2 of the July 2025 Acuerdo lists 104 low-risk device types that require no registro sanitario for production, sale or distribution and no import permit for entry; importers present at customs a declaration under protest that the product corresponds to Annex 2, and keep Aviso de Funcionamiento and Responsable Sanitario obligations; GMP and tecnovigilancia obligations still apply. Annex 3 lists 999+ products not considered medical devices.
Acuerdo signed 06-07-2025, in force the day after DOF publication.
Class-based registro sanitario filed on official format (national manufacture: RIS Art. 179; foreign manufacture adds RIS Art. 180 documents)
Annex 1 of the 2025 low-risk Acuerdo (93 items): registration with simplified requirements, resolved within 20 working days
Annex 2 (104 items): no registro sanitario required, no import permit required, but GMP and tecnovigilancia obligations remain
COFEPRIS-04-050: registration by equivalence with Autoridades Regulatorias de Referencia approvals (Lineamientos DOF 18-07-2025)
Corrects the baseline generic route description; reliance route additionally verified in the Lineamientos.
All medical device categories (equipos médicos, prótesis, órtesis, ayudas funcionales, agentes de diagnóstico, insumos odontológicos, material quirúrgico y de curación, productos higiénicos y otros dispositivos de uso médico) require a sanitary registration (registro sanitario) for production, sale and distribution; LGS Art. 376 excepts devices determined to be low risk that the sanitary authority exempts from registration.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
On 21–22 April 2021 COFEPRIS Commissioner Alejandro Svarch and NMPA Commissioner Jiao Hong signed, virtually, the 'Acuerdo entre la NMPA de la República Popular China y la Secretaría de Salud de los Estados Unidos Mexicanos sobre cooperación regulatoria de productos médicos'. Per Mexico's Foreign Ministry, both agencies undertake to take into account the registration information issued by the counterpart as a reference for registration in their own country, in line with applicable national law, to exchange information and to explore acceptance of GMP inspection results. It is a cooperation agreement; it does not itself create an abridged route, which now flows from the 2025 Lineamientos.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
mexico
Vaccines, medicines and medical devices/equipment (framework agreement)
Cooperation Mou
none
Product Marketing
Yes
Yes
Effective from 2021-04-21
Source passage: The agreement stipulates that both regulatory agencies will take into account the registration information issued by their counterpart as a reference for registration in their own country, in line with the applicable national legislation.
Prior approval / evidence record
Health Canada
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:mex
Health Canada medical device licence
Equivalence Or Abridged Review
facilitated
Product Marketing
Yes
Yes
Same COFEPRIS-04-050 mechanism as other ARR approvals under the Lineamientos.
Effective from 2025-07-19
Prior approval / evidence record
MDSAP
Yes
Full membership is recognised for the good-manufacturing-practice certificate, though not as a registration decision in its own right
Removes a separate GMP evidence step
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:mex
US FDA marketing authorization (510(k)/De Novo/PMA)
Equivalence Or Abridged Review
facilitated
Product Marketing
Yes
Yes
Available through COFEPRIS-04-050 where the approving regulator qualifies as an ARR (IMDRF Management Committee member country) under the Lineamientos.
Effective from 2025-07-19
ARR status now defined by IMDRF Management Committee membership rather than a fixed country list in the old guide.
Prior approval / evidence record
geo:mex
Japan MHLW/PMDA Ninsho or Shonin
Equivalence Or Abridged Review
facilitated
Product Marketing
Yes
Yes
Same COFEPRIS-04-050 mechanism as other ARR approvals under the Lineamientos.
Effective from 2025-07-19
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
If the applicant presents a favorable technical opinion (dictamen favorable) issued by a COFEPRIS-authorized third party (Tercero Autorizado) confirming safety and efficacy, the Secretaría must authorize the device registration within no more than 15 days.
Regulatory reference
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 Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.
Effective from 2025-07-19
Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.
Prior approval / evidence record
Japan PMDA
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:mex
GMP certificate issued under MDSAP full membership / recognized national regulatory agency
Qms Audit Reliance
Evidence Only
Qms Audit
Yes
Yes
Lineamientos Art. 24 recognizes GMP certificates from MDSAP full members as ARR evidence; RIS Art. 190 Bis 4 requires for the first prórroga of foreign-made devices a GMP certificate issued by a national regulatory agency recognized by the Secretaría.
Effective from 2025-07-19
Baseline fact previously FDA-page-backed; now verified in the Mexican DOF Lineamientos.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
The 2025 Lineamientos Article 24(I) recognises decisions of IMDRF Management Committee authorities for medical devices. NMPA is a committee member, so its qualifying product registration can support the COFEPRIS-04-050 equivalence application under Article 26(II), subject to the dossier in Article 31 and the Mexican decision. Article 24(II) separately addresses GMP certificates from MDSAP full members; IMDRF membership does not establish that a particular Chinese GMP document satisfies the GMP requirement.
china
nmpa
Qualifying NMPA Class II/III medical-device registration certificate
mexico
NMPA Class II and Class III registration certificates (medical devices and IVDs); target COFEPRIS registro sanitario of any class via COFEPRIS-04-050
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Solicitud de Registro Sanitario de Dispositivos Médicos por Equivalencia de Autoridades Regulatorias de Referencia (COFEPRIS-04-050)
Source passage: ARTÍCULO 24.- Para dispositivos médicos, la COFEPRIS reconoce las decisiones de las Autoridades Reguladoras de Referencia de: I. Países miembros del Management Committee del International Medical Device Regulators Forum (IMDRF); y, II. Miembros plenos del Programa de Auditoría Única de Dispositivos Médicos (MDSAP por sus siglas en inglés), para Certificados de Buenas Prácticas de Fabricación.
What review, validation, and applicant stop-clock rules apply?
The Secretaría must resolve Class I device registration applications within 30 days; if it does not resolve in that period, the application is deemed granted (afirmativa ficta). Classes II and III have resolution periods of 35 and 60 days respectively (without the express positive-silence sentence).
Applications to modify the conditions of a device registration (Capítulo IX insumos) must be resolved within 22 days; if the Secretaría does not resolve in that period the modification is deemed approved.
First-prórroga applications must be filed 150 natural days before the registration expires; the Secretaría must resolve within a maximum of 120 natural days after filing, and if it does not resolve the prórroga is deemed granted. Second and later prórrogas are applied for every five years, at the latest 150 natural days before expiry; the acknowledgment receipt (constancia) itself has the effect of extending the registration.
Effective from 2021-06-01
LGS Art. 376 (reformed 10-05-2023) states prórrogas are granted for 10-year periods; the RIS filing cadence for later prórrogas remains every five years - both retained per effective dates.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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; 39-75 in 2026-2027; 76-116 in 2027-2028; latest filing in 2029); exception letters lapse after five years.
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
Products, equipment, devices or apparatus intended for telecommunications or broadcasting that can be connected to a network or use the radioelectric spectrum must be homologated under applicable NOMs or Technical Provisions (LFTR Art. 289); the obligation is not limited to public networks. The IFT homologation lineamientos provide a Tipo A registry applicable to scientific, medical or industrial equipment, subject to non-interference conditions.
Medicines, medical devices and other health supplies are governed by the Farmacopea de los Estados Unidos Mexicanos (LGS Art. 195, paragraph reformed DOF 10-05-2023), which the Secretaría keeps permanently updated; device registrations require laboratory tests verifying product specifications (RIS Art. 179 VII).
Effective from 2023-05-11
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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 Administrativo (as listed in the official ficha foundations); several device clocks carry positive silence (deemed approval) rules - Class I registration (RIS Art. 179), modifications (RIS Art. 188) and prórrogas (RIS Art. 190 Bis 6) - and the ficha records the ficta framework (LFPA Art. 17, second paragraph, and the 2011 RFTS Acuerdo, Art. Décimo primero).
Which UDI, device listing, database, and traceability duties apply?
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 institutions open access to valid device registrations, continuously updated; holders may submit per-registration corrections within two weeks of the launch via the COFEPRIS format to digipris@cofepris.gob.mx.
Effective from 2026-08-20
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 provides; the same key is preserved across prórrogas.
What is reportable, by whom, where, in what format, and by what deadline?
Adverse reactions of medicines or other insumos (including devices) arising during commercialization or use, notified by health professionals, published in scientific literature, or reported by international health bodies must be brought to the IMMEDIATE knowledge of the Secretaría by the registration holder, distributors or commercializers.
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 Farmacovigilancia (DEFFV), with separate online portals for registration holders (NotificacionTitular), health professionals (NotificacionProfesional) and users/patients (NotificacionPaciente) at tramiteselectronicos03.cofepris.gob.mx/TecnoVigilancia; official notification formats are published by COFEPRIS.
mexico:medical-device
mexico
Risk classes I through III.
i
Class I
low
ii
Class II
medium
iii
Class III
highest
COFEPRIS
official-source-verified
Reglamento de Insumos para la Salud, Art. 83 (clases de riesgo)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
Mexico
mexico
MX
🇲🇽
Comisión Federal para la Protección contra Riesgos Sanitarios
COFEPRIS
americas
2
3-class (I, II, III)
class-i
Class I
low
Libre de Venta (LR) or Registration
30
30
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
3
3
months
No
No
No
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
FDA 510(k)/PMA
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
Health Canada
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
EU CE Mark
Yes
The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
Resolution capped at 30 working days
Japan PMDA
Yes
Reference Regulatory Authority for the abbreviated pathway
Resolution capped at 30 working days
MDSAP
Yes
Full membership is recognised for the good-manufacturing-practice certificate, though not as a registration decision in its own right
Removes a separate GMP evidence step
Yes
Mexico Registration Holder (MRH)
Yes
Since the July 2025 Lineamientos, MDSAP full members are recognised for the good-manufacturing-practice certificate. It is not a substitute for the registration decision itself, which still goes through COFEPRIS-04-050 or the ordinary route.
5 years
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
COFEPRIS ARR equivalence Lineamientos (DOF 18-07-2025) — 30 working days
https://sidof.segob.gob.mx/notas/docFuente/5763319
2025-07-18
2026-08-25
COFEPRIS reliance briefing — abbreviated pathway in force 30 working days after the 18-07-2025 DOF publication, ARR list, 30-working-day resolution, device homoclaves
https://www.gob.mx/cms/uploads/attachment/file/1084063/RELIANCE_12062026.pdf
2026-08-30
Acuerdo Anexo Uno (July 2025) — low-risk registration 20 working days
https://sidof.segob.gob.mx/notas/docFuente/5762237
2026-08-25
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by COFEPRIS. Appoint a Mexico Registration Holder (MRH).
1-3 months
📋
2
Application Submission
Submit complete registration dossier to COFEPRIS including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
COFEPRIS reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. COFEPRIS may issue questions.
30 days
⚙️
5
Registration Approval
Upon successful review, COFEPRIS issues Mexico market authorization certificate.
1-2 weeks
✅
mexico
Mexico
MX
COFEPRIS
12374.03
16498.7
MXN
Yes
23098.18
30797.57
MXN
Yes
initial-registration-class-i
Initial registration - Class I (LFD Art. 195-A III)
MXN
16498.7
MXN 16,498.70
Per device
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
initial-registration-class-ii
Initial registration - Class II (LFD Art. 195-A III)
MXN
24198.08
MXN 24,198.08
Per device
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
initial-registration-class-iii
Initial registration - Class III (LFD Art. 195-A III)
MXN
30797.57
MXN 30,797.57
Per device
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
second-subsequent-renewal-class-i
Second and subsequent renewal - Class I (75%)
MXN
12374.03
MXN 12,374.03
Per renewal
Modifications, renewals, and extensions collect 75% of the corresponding fee; holder-name changes 50% (LFD Art. 195-A final paragraphs).
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
second-subsequent-renewal-class-ii
Second and subsequent renewal - Class II (75%)
MXN
18148.56
MXN 18,148.56
Per renewal
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
second-subsequent-renewal-class-iii
Second and subsequent renewal - Class III (75%)
MXN
23098.18
MXN 23,098.18
Per renewal
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
import-permit-application
Import permit - raw material or finished product (LFD Art. 195-G III)
MXN
3116.65
MXN 3,116.65
Per application
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
import-permit-donation
Import permit - donation
MXN
440.45
MXN 440.45
Per application
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
import-permit-modification
Import-permit modification, correction, or extension
MXN
440.45
MXN 440.45
Per application
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
clinical-protocol-authorization
Clinical-research protocol authorization (LFD Art. 195-I VI)
MXN
8195.58
MXN 8,195.58
Per protocol application
Protocol modifications collect 75%; the COFEPRIS-04-010 ficha displays the rounded MXN 8,196.00.
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
free-sale-certificate
Free-sale certificate for export of insumos (LFD Art. 195-E I)
MXN
2965.09
MXN 2,965.09
Per certificate
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
gmp-certificate
GMP certificate for insumos para la salud (LFD Art. 195-E X)
MXN
2783.8
MXN 2,783.80
Per certificate
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
cession-rights-individual
Cession-of-rights inscription - individuals (LFD Art. 195-K)
MXN
201.4
MXN 201.40
Per inscription
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
cession-rights-legal-entity
Cession-of-rights inscription - legal entities
MXN
1009.88
MXN 1,009.88
Per inscription
exact-current
official-verified
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
2026-01-01
2026-08-25
2026-08-25
official-verified
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
2026-01-01
2026-08-25
COFEPRIS 2026 federal-rights tariff table
https://www.gob.mx/cms/uploads/attachment/file/1049620/TarifasDePagos2026.pdf
2026-01-01
2026-08-25
COFEPRIS-04-060 medical-device registration procedure
https://www.gob.mx/public/tramites/detalleTramite.xhtml?homoclave=COFEPRIS-04-060
2026-01-01
2026-08-25
COFEPRIS second and subsequent registration renewal
https://www.gob.mx/public/tramites/detalleTramite.xhtml?homoclave=COFEPRIS-2022-022-006-A
2026-01-01
2026-08-25
2026-08-25
exact-current
Yes
mexico
Mexico
high
cofepris-electrical-emc-evidence
COFEPRIS electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
unresolved
ift-homologation-type-a
IFT Homologation Type A
Radio Spectrum
Mandatory If Feature
Eligible Equipment Route
candidate
ift-homologation-type-b
IFT Homologation Type B
Radio Spectrum
Mandatory If Feature
Eligible Equipment Route
candidate
ift-homologation-type-c
IFT Homologation Type C
Radio Spectrum
Mandatory If Feature
Eligible Equipment Route
candidate
ift-type-a-registration
IFT Type A Registration
Radio Spectrum
Mandatory If Feature
Inherently Conforming Or Scientific Medical Industrial Equipment
candidate
nom-electrical-emc-conformity
NOM electrical/EMC conformity
General Electrical Components
Mandatory If Feature
Product Or Component In Scope
unresolved
IFT
Homologation Guidelines including Type A, B and C
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
IFT
homologation FAQ
https://www.ift.org.mx/industria/preguntas-frecuentes-en-materia-de-homologacion
IFT
homologated equipment database
https://ehomologados.ift.org.mx/
