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Mexico Medical Device Registration

Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) approval timelines and requirements

2-4 months
Typical Timeline
3
Device Classes
No
MDSAP Accepted
Required
Mexico Registration Holder (MRH)

Mexico Medical Device Registration Overview

Mexico medical device registration through COFEPRIS typically takes 2-4 months for Class I devices. The official COFEPRIS target is 1-3 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Mexico uses a 3-class (I, II, III) risk-based classification system. Foreign manufacturers must appoint a Mexico Registration Holder (MRH) to register devices in Mexico. Registration is valid for 5 years.

Registration Timeline by Device Class

Mexico uses a 3-class (I, II, III) risk-based classification system.

Class I

Registration

Low Risk
Official
1-3 months
Realistic
2-4 months

• Simplified pathway

Class II

Registration or Equivalency

Medium Risk
Official
4-8 months
Realistic
1.3-2.7 years
With Prior Approval
8-16 months

Accelerated with: FDA 510(k), Health Canada, Japan PMDA

• Equivalency route much faster if FDA approved

GMP/QMS Required

Class III

Registration or Equivalency

Highest Risk
Official
6-12 months
Realistic
1.3-2.7 years
With Prior Approval
8-16 months

Accelerated with: FDA 510(k)/PMA, Health Canada, Japan PMDA

• Equivalency pathway best option with FDA

Clinical Trial RequiredGMP/QMS Required
Expedited Pathways

Equivalency Pathway

Leverages FDA, Health Canada, Japan PMDA approvals

50-70% faster
Eligibility: FDA 510(k)/PMA, Health Canada license, Japan PMDA approval

Expanded Pathway (Sept 2025)

Will accept EU, Brazil, Australia, South Korea, China approvals

TBD - effective September 2025
Eligibility: Additional country approvals
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Mexico registration.

FDA 510(k)
Equivalency pathway - 50-70% faster
4-8 months
Health Canada
Equivalency pathway
4-8 months
EU CE Mark
Will be accepted from Sept 2025
Future
Japan PMDA
Equivalency pathway
4-8 months
Key Requirements
  • Mexico Registration Holder (MRH) - mandatory for foreign manufacturers
  • NOM certification (GMP, labeling)
  • Spanish labeling and IFU
  • Free Sale Certificate
Registration Validity:

5 years

Registration Process Flowchart

Mexico Medical Device Registration Process

Step-by-step COFEPRIS registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by COFEPRIS. Appoint a Mexico Registration Holder (MRH).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to COFEPRIS including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

COFEPRIS reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-3 months

In-depth technical assessment of device safety and performance. COFEPRIS may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, COFEPRIS issues Mexico market authorization certificate.

Summary: The Mexico medical device registration process through Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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Related Resources
Mexico GMP RequirementsChoose a Mexico Registration HolderCOFEPRIS Regulation NewsGovernment Registration Fees
Compare With
🇺🇸 United StatesFDA🇪🇺 European UnionEU MDR🇨🇳 ChinaNMPA🇯🇵 JapanPMDA🇧🇷 BrazilANVISA🇨🇦 CanadaHealth Canada
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.