COFEPRIS · structured requirements

🇲🇽 Mexico IVD regulatory data

Explore the IVD requirements currently available for Mexico, organized by topic and linked to official sources.

15 facts6 dimensions14 official sourceslatest verification 2026-10-21

Changes after registration

Common questions about changing a registered IVD in Mexico. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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B5 is an address-expression correction at the same physical place

changes.address-expression-same-place

Fact-level verified

B5 covers a changed expression of the actual/legal manufacturer’s site address only where the physical place is unchanged and no manufacturing-site change occurs. Provide the manufacturer’s justified statement; official postal/government reassignment evidence applies where that explains the change. A move to a different office address is not proved to fall within this same-place exception, even when the factory stays put; identify which legal/actual-manufacturer field and establishment changes.

Conditions

An actual factory change is outside this question and follows its own technical route.

Administrative change, rights assignment, holder/distributor/importer

Trade-name/catalogue changes have a specific adjudicated administrative route

changes.brand-and-catalogue-admin-change

Fact-level verified

The current003 service lists B3 for a device trade-name or catalogue-number change. The guide requires the manufacturer’s justified change statement and no technical change to the authorized sanitary conditions; use the current form and type-specific evidence. Its note says the catalogue/reference/model/code number may not be eliminated through this catalogue-change route. The separately incorporated criteria also list presentation elimination/reference-code changes, so distinguish the actual requested change rather than treating all REF operations identically.

Administrative and technical modification criteria Official classification criteria for device registration modifications

Use the current administrative modality and document limits

changes.current-admin-filing-requirements

Fact-level verified

The July 2025 agreement merges administrative changes and device registration-rights assignment into COFEPRIS-2022-022-003 immediateA/adjudicatedB. May 2026 ArtV requires FF-COFEPRIS-15 or the digital form, fee proof and the document for the actual modification under the incorporated classification criteria. ArtIX prohibits demanding COFEPRIS-issued documents, simple-copy duplicates or additional requirements beyond that agreement; legal-representation evidence applies as stated. Older guide copy/duplicate instructions must be read with these later rules.

Simplification agreement official native body2026

New legal manufacturer is B2, separate from local holder assignment

changes.foreign-legal-manufacturer-replacement

Fact-level verified

B2 is change/addition of the legal manufacturer responsible for device quality. Supply the legal document justifying the change, authenticated/translated as stated for foreign manufacture, and the applicable representation letter. The guide allows the stated CFS or legal relationship document and limits this route to unchanged sanitary conditions that could affect quality, safety or effectiveness. It is not a simple B1 same-person rename and does not itself assign the Mexican registration to a new holder.

Administrative change, rights assignment, holder/distributor/importer

Local registration-rights assignment has its own evidence and deadline

changes.holder-rights-assignment

Fact-level verified

The new holder must notify assignment within 30 working days after it occurs. The guide requires a deed identifying the transferred registrations signed by assignor and assignee, matching the current holder and a valid registration or pending renewal, plus the applicable new-holder label and representation evidence. The current administrative service includes assignment under adjudication; later simplification removes superseded duplicate/copy requirements. A foreign manufacturer succession and a Mexican holder assignment must be mapped separately.

Administrative and technical modification criteria Simplification agreement official native body2026

Same-person name change is B1, not assignment of rights

changes.same-person-name-admin-change

Fact-level verified

B1 covers the holder, distributor, importer or actual/legal manufacturer’s business-name change excluding assignment. Provide the applicable official/legal or manufacturer name-change proof and representation evidence for the domestic/foreign role, authenticated and translated as specified. The guide permits one original to be referenced in separate name-change applications; it does not turn several registrations into one application. Read its copy requirements subject to the later simplification agreement.

Administrative change, rights assignment, holder/distributor/importer Simplification agreement official native body2026

Fees

What regulator fee applies to this class, route, event, and date?

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Modification fees use a change-specific percentage of the class rate

changes.modification-percentage-fees

Fact-level verified

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

Conditions

Use the current assessed fee and applicable rounding/payment rules; the published service range is not a portfolio-wide total.

Administrative and technical modification criteria

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Current labels must identify the correct product and roles

changes.current-label-name-role-consistency

Fact-level verified

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

Conditions

NOM 137-SSA1-2025 has a deferred360-calendar-day commencement and its own transition; do not apply its label provisions early without checking the actual date.

Stock exhaustion is set by the actual authorization

changes.decision-specific-stock-limit

Fact-level verified

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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CFS and GMP evidence follow the actual modification branch

changes.cfs-gmp-alternatives-boundary

Fact-level verified

The guide treats CFS, legal manufacturer relationship/representation documents and GMP evidence as different documents. In B2 it permits the stated CFS or legal relationship document; actual manufacturing-site/technical branches have their own supporting evidence. The 20March2025 formal lineamientos Art. 15 recognizes the stated MDSAP, reference-authority GMP, current accredited ISO13485, CE and official-CFS explicit-GMP alternatives for devices. Authentication, electronic verification and validity rules still apply. This does not require a new CFS for every logo or internal REF change.

GMP supporting certificate lineamientos original Gazette

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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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.

Mexico approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Mexico (10 records)

MexicoNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Swissmedic · South Korea MFDS · Singapore HSA · Brazil ANVISA · IMDRF member authorities · MDSAP · WHO

Prior approval / evidence record

Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)

Name: Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
Description: 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.
Timeline Reduction: Resolution within a maximum of 30 working days
Eligibility: Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States
MDSAP full members are recognised for the good-manufacturing-practice certificate
Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration
Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)COFEPRIS ARR equivalence Lineamientos (DOF 18-07-2025) — 30 working days 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 Acuerdo Anexo Uno (July 2025) — low-risk registration 20 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
Timeline Savings: Resolution capped at 30 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoNMPA

Prior approval / evidence record

NMPA-COFEPRIS regulatory cooperation agreement (2021)

reliance.china-nmpa-bilateral-programme

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: mexico
China Classes In Scope: Vaccines, medicines and medical devices/equipment (framework agreement)
Edge Type: Cooperation Mou
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Reference use of counterpart registration information 'in line with the applicable national legislation'
Exploration of mutual acceptance of GMP inspection results
No product-specific pilot or list published
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

MexicoHealth Canada

Prior approval / evidence record

Health Canada

Authority: Health Canada
Accepted: Yes
Benefit: Reference Regulatory Authority for the abbreviated pathway
Timeline Savings: Resolution capped at 30 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration or Equivalency

Official Timeline

Min: 35
Max: 35
Unit: days

Verification Status

official-verified

Official Source

Title: RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url: https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

Prior Approval Benefits

FDA 510(k)
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP

Notes

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

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoMDSAP

Prior approval / evidence record

MDSAP

Authority: MDSAP
Accepted: Yes
Benefit: Full membership is recognised for the good-manufacturing-practice certificate, though not as a registration decision in its own right
Timeline Savings: Removes a separate GMP evidence step

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities · MDSAP

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

highest

Pathway

Registration or Equivalency

Official Timeline

Min: 60
Max: 60
Unit: days

Verification Status

official-verified

Official Source

Title: RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url: https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date: 2026-08-25

Realistic Timeline

Min: 15
Max: 31
Unit: months

With Prior Approval

Min: 8
Max: 16
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP

Notes

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

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

RIS Art. 179 — statutory resolution periods by class (COFEPRIS)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoJapan MHLW / PMDA

Prior approval / evidence record

Japan PMDA

Authority: Japan PMDA
Accepted: Yes
Benefit: Reference Regulatory Authority for the abbreviated pathway
Timeline Savings: Resolution capped at 30 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Reference Regulatory Authority for the abbreviated pathway
Timeline Savings: Resolution capped at 30 working days

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MexicoNMPA

Prior approval / evidence record

China NMPA approval: qualifies as IMDRF-member reference authority (COFEPRIS-04-050 equivalence)

reliance.china-nmpa-reliance-route

Fact-level verified

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: Qualifying NMPA Class II/III medical-device registration certificate
Target Jurisdiction Id: mexico
China Classes In Scope: NMPA Class II and Class III registration certificates (medical devices and IVDs); target COFEPRIS registro sanitario of any class via COFEPRIS-04-050
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes
Target Route: Solicitud de Registro Sanitario de Dispositivos Médicos por Equivalencia de Autoridades Regulatorias de Referencia (COFEPRIS-04-050)

Conditions

Art. 31 I: RUPA, fee, Spanish label, IFU, GMP certificate or equivalent, Certificate of Free Sale issued by the ARR, the ARR's marketing authorization for the device, representation letter where applicable
Art. 31 II: descriptive information, components, manufacturing summary, the conformity assessment submitted to the ARR, packaging, clinical evaluation, risk analysis, CoA, technovigilance report
COFEPRIS retains the decision; Lineamientos in force 30 business days after DOF publication (Acuerdo, Primero)

IMDRF Management Committee — current members

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.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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The current adjudicated administrative service publishes15 working days

changes.administrative-clock-conditional-current-service

Fact-level verified

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

Simplification agreement official native body2026

Technical change timing is a separate service

changes.technical-clock-separate

Fact-level verified

The August2025 agreement’s ArtV table specifies an intended reduction for COFEPRIS-2022-022-004-A technical modification from22 to11 working days. Its transitory5 makes that reduction operative only after180 working days from the day after publication and once the necessary technological tools/platforms are implemented, enabled and functioning. Apply the11-working-day period only when that implementation condition is established for the actual accepted technical service. It is not the clock for B1/B2/B3/B5 administrative changes or a period automatically added to15 working days for a supposed combined filing.

Conditions

Technical site/process changes are separate from same-site name/artwork cases. Apply the route’s completeness and LFPA deficiency rules.
This review does not independently certify functionality of a particular applicant’s technical application platform.

Deficiency requests can stop the applicable modification clock

changes.variation-information-stop-clock

Fact-level verified

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

Related structured datasets

Classification systems · 1 record

Open Risk classes I through III. →

mexico:medical-device

Jurisdiction Id

mexico

Domains

medical-device
ivd

Name

Risk classes I through III.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

COFEPRIS

Official Domains

gob.mx
salud.gob.mx
sidof.segob.gob.mx

Source Status

official-source-verified

Source Title

Reglamento de Insumos para la Salud, Art. 83 (clases de riesgo)

Source Url

https://salud.gob.mx/unidades/cdi/nom/compi/ris.html

Verified On

2026-08-25

Source Supports

class-axis

Notes

RIS Art. 83: Clase I (known in medical practice, proven safety/efficacy, generally not introduced into the body); Clase II (known, may vary in material/concentration, generally introduced for less than 30 days); Clase III (new or recently accepted, or remaining in the body more than 30 days). Classification is made by the Secretaría per risk of use.
Since July 2025 a parallel listing layer applies (Acuerdo signed 06-07-2025): Annex 1 low-risk devices (93 items) still require registration with simplified requirements; Annex 2 (104 items) are exempt from registration; Annex 3 (999+ items) are not medical devices.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mexico registration →

Country

Mexico

Jurisdiction Id

mexico

Country Code

Flag

🇲🇽

Regulator

Comisión Federal para la Protección contra Riesgos Sanitarios

Regulator Abbrev

COFEPRIS

Region

americas

Tier

Risk Classification

3-class (I, II, III)

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Libre de Venta (LR) or Registration
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date
2026-08-25
Realistic Timeline
Min
3
Max
3
Unit
months
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
Registration or Equivalency
Official Timeline
Min
35
Max
35
Unit
days
Verification Status
official-verified
Official Source
Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date
2026-08-25
Realistic Timeline
Min
15
Max
31
Unit
months
With Prior Approval
Min
8
Max
16
Unit
months
Prior Approval Benefits
FDA 510(k)
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iii
Class Name
Class III
Risk Level
highest
Pathway
Registration or Equivalency
Official Timeline
Min
60
Max
60
Unit
days
Verification Status
official-verified
Official Source
Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date
2026-08-25
Realistic Timeline
Min
15
Max
31
Unit
months
With Prior Approval
Min
8
Max
16
Unit
months
Prior Approval Benefits
FDA 510(k)/PMA
Health Canada
Japan PMDA
IMDRF Committee Members
MDSAP
Notes
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
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
Description
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.
Timeline Reduction
Resolution within a maximum of 30 working days
Eligibility
Prior authorisation by a Reference Regulatory Authority in one of the twelve IMDRF Management Committee jurisdictions: Australia, Brazil, Canada, China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom, the United States
MDSAP full members are recognised for the good-manufacturing-practice certificate
Filed under homoclave COFEPRIS-04-050 rather than the ordinary COFEPRIS-04-060 registration
Post-market surveillance or technovigilance evidence from the reference market, translated into Spanish under RIS Art. 153

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Reference Regulatory Authority for the abbreviated pathway
Timeline Savings
Resolution capped at 30 working days
Authority
Health Canada
Accepted
Yes
Benefit
Reference Regulatory Authority for the abbreviated pathway
Timeline Savings
Resolution capped at 30 working days
Authority
EU CE Mark
Accepted
Yes
Benefit
The European Union sits on the IMDRF Management Committee, so it became a Reference Regulatory Authority under the July 2025 Lineamientos
Timeline Savings
Resolution capped at 30 working days
Authority
Japan PMDA
Accepted
Yes
Benefit
Reference Regulatory Authority for the abbreviated pathway
Timeline Savings
Resolution capped at 30 working days
Authority
MDSAP
Accepted
Yes
Benefit
Full membership is recognised for the good-manufacturing-practice certificate, though not as a registration decision in its own right
Timeline Savings
Removes a separate GMP evidence step

Key Requirements

Mexico Registration Holder (MRH) - mandatory for foreign manufacturers
NOM certification (GMP, labeling)
Spanish labeling and IFU
Free Sale Certificate
First prórroga filed 150 natural days before expiry and resolved within a maximum of 120 days (RIS Arts. 190 Bis 6-7); Annex 1 dossier deficiencies cured within 20 working days

Local Rep Required

Yes

Local Rep Name

Mexico Registration Holder (MRH)

Mdsap Accepted

Yes

Mdsap Benefit

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.

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
Url
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
Accessed Date
2026-08-25
Title
COFEPRIS ARR equivalence Lineamientos (DOF 18-07-2025) — 30 working days
Url
https://sidof.segob.gob.mx/notas/docFuente/5763319
Effective Date
2025-07-18
Accessed Date
2026-08-25
Title
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
Url
https://www.gob.mx/cms/uploads/attachment/file/1084063/RELIANCE_12062026.pdf
Accessed Date
2026-08-30
Title
Acuerdo Anexo Uno (July 2025) — low-risk registration 20 working days
Url
https://sidof.segob.gob.mx/notas/docFuente/5762237
Accessed Date
2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by COFEPRIS. Appoint a Mexico Registration Holder (MRH).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to COFEPRIS including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
COFEPRIS reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. COFEPRIS may issue questions.
Duration
30 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, COFEPRIS issues Mexico market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mexico fees →

Jurisdiction Id

mexico

Country

Mexico

Country Code

Authority

COFEPRIS

Low Risk Local

Min: 12374.03
Max: 16498.7
Currency: MXN
Per Product: Yes

High Risk Local

Min: 23098.18
Max: 30797.57
Currency: MXN
Per Product: Yes

Details

Id
initial-registration-class-i
Item
Initial registration - Class I (LFD Art. 195-A III)
Currency
MXN
Amount Local
16498.7
Amount Local Formatted
MXN 16,498.70
Frequency
Per device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
initial-registration-class-ii
Item
Initial registration - Class II (LFD Art. 195-A III)
Currency
MXN
Amount Local
24198.08
Amount Local Formatted
MXN 24,198.08
Frequency
Per device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
initial-registration-class-iii
Item
Initial registration - Class III (LFD Art. 195-A III)
Currency
MXN
Amount Local
30797.57
Amount Local Formatted
MXN 30,797.57
Frequency
Per device
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
second-subsequent-renewal-class-i
Item
Second and subsequent renewal - Class I (75%)
Currency
MXN
Amount Local
12374.03
Amount Local Formatted
MXN 12,374.03
Frequency
Per renewal
Notes
Modifications, renewals, and extensions collect 75% of the corresponding fee; holder-name changes 50% (LFD Art. 195-A final paragraphs).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
second-subsequent-renewal-class-ii
Item
Second and subsequent renewal - Class II (75%)
Currency
MXN
Amount Local
18148.56
Amount Local Formatted
MXN 18,148.56
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
second-subsequent-renewal-class-iii
Item
Second and subsequent renewal - Class III (75%)
Currency
MXN
Amount Local
23098.18
Amount Local Formatted
MXN 23,098.18
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
import-permit-application
Item
Import permit - raw material or finished product (LFD Art. 195-G III)
Currency
MXN
Amount Local
3116.65
Amount Local Formatted
MXN 3,116.65
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
import-permit-donation
Item
Import permit - donation
Currency
MXN
Amount Local
440.45
Amount Local Formatted
MXN 440.45
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
import-permit-modification
Item
Import-permit modification, correction, or extension
Currency
MXN
Amount Local
440.45
Amount Local Formatted
MXN 440.45
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
clinical-protocol-authorization
Item
Clinical-research protocol authorization (LFD Art. 195-I VI)
Currency
MXN
Amount Local
8195.58
Amount Local Formatted
MXN 8,195.58
Frequency
Per protocol application
Notes
Protocol modifications collect 75%; the COFEPRIS-04-010 ficha displays the rounded MXN 8,196.00.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
free-sale-certificate
Item
Free-sale certificate for export of insumos (LFD Art. 195-E I)
Currency
MXN
Amount Local
2965.09
Amount Local Formatted
MXN 2,965.09
Frequency
Per certificate
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
gmp-certificate
Item
GMP certificate for insumos para la salud (LFD Art. 195-E X)
Currency
MXN
Amount Local
2783.8
Amount Local Formatted
MXN 2,783.80
Frequency
Per certificate
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
cession-rights-individual
Item
Cession-of-rights inscription - individuals (LFD Art. 195-K)
Currency
MXN
Amount Local
201.4
Amount Local Formatted
MXN 201.40
Frequency
Per inscription
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
cession-rights-legal-entity
Item
Cession-of-rights inscription - legal entities
Currency
MXN
Amount Local
1009.88
Amount Local Formatted
MXN 1,009.88
Frequency
Per inscription
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Source Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Source Effective Date
2026-01-01
Verified On
2026-08-25

Notes

Amounts are the exact 2026 statutory figures of the Ley Federal de Derechos, Arts. 195-A to 195-K (RMF 2026, DOF 28 December 2025).
Advertising permits (LFD Art. 195-I) are billed per product and message type, e.g. MXN 44,252.23 TV/Internet, MXN 6,196.26 outdoor, MXN 1,161.80 press, MXN 800.35 catalogs/flyers.
Payment must use the current generated payment sheet (formato de pago).

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Mexico Ley Federal de Derechos, Arts. 195-A to 195-K (2026 amounts)
Url
https://www.diputados.gob.mx/LeyesBiblio/pdf/LFD.pdf
Effective Date
2026-01-01
Accessed Date
2026-08-25
Title
COFEPRIS 2026 federal-rights tariff table
Url
https://www.gob.mx/cms/uploads/attachment/file/1049620/TarifasDePagos2026.pdf
Effective Date
2026-01-01
Accessed Date
2026-08-25
Title
COFEPRIS-04-060 medical-device registration procedure
Url
https://www.gob.mx/public/tramites/detalleTramite.xhtml?homoclave=COFEPRIS-04-060
Effective Date
2026-01-01
Accessed Date
2026-08-25
Title
COFEPRIS second and subsequent registration renewal
Url
https://www.gob.mx/public/tramites/detalleTramite.xhtml?homoclave=COFEPRIS-2022-022-006-A
Effective Date
2026-01-01
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mexico certifications →

Slug

mexico

Market

Mexico

Confidence

high

Schemes

Id
cofepris-electrical-emc-evidence
Name
COFEPRIS electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Source Binding
unresolved
Id
ift-homologation-type-a
Name
IFT Homologation Type A
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Equipment Route
Source Urls
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
Source Binding
candidate
Id
ift-homologation-type-b
Name
IFT Homologation Type B
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Equipment Route
Source Urls
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
Source Binding
candidate
Id
ift-homologation-type-c
Name
IFT Homologation Type C
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Equipment Route
Source Urls
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
Source Binding
candidate
Id
ift-type-a-registration
Name
IFT Type A Registration
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Inherently Conforming Or Scientific Medical Industrial Equipment
Source Urls
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
Source Binding
candidate
Id
nom-electrical-emc-conformity
Name
NOM electrical/EMC conformity
Category
General Electrical Components
Status
Mandatory If Feature
Object
Product Or Component In Scope
Source Binding
unresolved

Official Sources

Authority
IFT
Topic
Homologation Guidelines including Type A, B and C
Url
https://www.ift.org.mx/industria/lineamientos-para-la-homologacion-de-productos-equipos-dispositivos-o-aparatos-destinados
Authority
IFT
Topic
homologation FAQ
Url
https://www.ift.org.mx/industria/preguntas-frecuentes-en-materia-de-homologacion
Authority
IFT
Topic
homologated equipment database
Url
https://ehomologados.ift.org.mx/

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Need to apply Mexico's requirements to a product?

Confirm the current COFEPRIS pathway, evidence, and local-role details for the actual device before filing.

Pricing

Changes after registration

Change control

B5 is an address-expression correction at the same physical place

Trade-name/catalogue changes have a specific adjudicated administrative route

Use the current administrative modality and document limits

New legal manufacturer is B2, separate from local holder assignment

Local registration-rights assignment has its own evidence and deadline

Same-person name change is B1, not assignment of rights

Fees

Modification fees use a change-specific percentage of the class rate

Label, IFU & language

Current labels must identify the correct product and roles

Stock exhaustion is set by the actual authorization

Official forms & portals

CFS and GMP evidence follow the actual modification branch

Reliance & recognition

Mexico approvals and evidence in other markets (0 records)

Prior approvals and evidence for Mexico (10 records)

Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)

EU CE Mark

NMPA-COFEPRIS regulatory cooperation agreement (2021)

Health Canada

Class II

MDSAP

Class III

Japan PMDA

FDA 510(k)/PMA

China NMPA approval: qualifies as IMDRF-member reference authority (COFEPRIS-04-050 equivalence)

Review clocks

The current adjudicated administrative service publishes15 working days

Technical change timing is a separate service

Deficiency requests can stop the applicable modification clock

Related structured datasets

More Mexico medical device resources