What is a Mexico Registration Holder (MRH) and why is it legally required?

A Mexico Registration Holder (MRH) is the mandatory local representative for foreign medical device manufacturers. COFEPRIS requires an MRH to submit registration applications, maintain regulatory compliance, and serve as the official contact for Mexican health authorities.

Should I use an independent MRH or appoint my distributor as MRH?

Independent MRH is strongly recommended. Using your distributor as MRH creates business dependency - if you switch distributors, you lose control of COFEPRIS registrations. Independent MRHs preserve flexibility and protect your regulatory assets.

What are typical Mexico Registration Holder costs and pricing structures?

MRH costs depend on device class and pathway. Low Risk (LR): $1,000-$2,000. Class I: $3,000-$4,000. Class II/III: $5,000-$7,000 per registration. Annual representative fees: $3,000-$5,000. Registrations valid 5 years with renewal at 50% original cost.

How do I evaluate MRH pricing transparency and avoid hidden fees?

Leading MRHs publish pricing ranges on websites ($1K-$7K by device class). Red flags: 'contact for quote only', hidden fees during project, hourly billing without caps. Pure Global provides transparent published rates and fixed-fee options.

What is the new COFEPRIS Abbreviated Pathway and how can I leverage it?

Effective September 1, 2025, the Abbreviated Pathway (Equivalence Route) allows devices with existing IMDRF or MDSAP member approvals to receive COFEPRIS review in 30 working days. This applies to devices already approved in USA (FDA), EU (CE Mark), Canada, Japan, Australia, or other recognized markets.

What experience and qualifications should I require from a Mexico Registration Holder?

Require 5+ years COFEPRIS experience, local Mexico office presence, Spanish/English fluency, proven track record with your device class, and client references. Verify regulatory consultant licensing and professional liability insurance coverage.

What services and support should a comprehensive MRH provide beyond basic registration?

Leading MRHs provide classification guidance, pathway selection, dossier compilation, Spanish translation, post-market surveillance infrastructure, modification management, renewal coordination, and regulatory intelligence. Look for value-added services like free classification tools and online portals.

Choose a Mexico Registration Holder (MRH) FAQ - Updated October 2025

How To 7 Critical Criteria for Selecting Your MRH. Expert guidance by Pure Global regulatory specialists

Selection Guide

COFEPRIS

Market Entry

Pure Global: Mexico Registration Holder (MRH) Services

Accelerate your COFEPRIS market entry with transparent pricing, expert guidance, and independent MRH status. Pure Global serves 30+ countries with local Mexico presence.

Pure Global combines regulatory expertise with AI-powered tools to streamline COFEPRIS registration. Our independent MRH services ensure you maintain full control of your registrations while receiving expert guidance on classification, dossier compilation, and the new Abbreviated Pathway for faster approvals.

✓ Transparent Pricing

Published rates: LR $1K-$2K, Class I $3K-$4K, Class II/III $5K-$7K

✓ Abbreviated Pathway Expertise

Leverage existing FDA/EU approvals for 30-day COFEPRIS review times

✓ Independent MRH Status

Not affiliated with distributors - you control your registrations

✓ Proven Global Experience

30+ countries, local Mexico office, Spanish/English fluency

Mexico Market Size

$12.6B

Total medical device market (2024)

Market Growth

7.6% CAGR

Expected growth rate 2024-2029

Registration Timeline

30-90 days

COFEPRIS review (Abbreviated vs Standard)

Registration Validity

5 years

Renewal required at 50% original cost

Frequently Asked Questions

On This Page

Understanding Mexico Registration Holder (MRH) Requirements

Evaluating MRH Pricing and Transparency

COFEPRIS Pathways and Timelines

MRH Selection Criteria and Due Diligence

Quick Resources

All Mexico Regulations Mexico How-To Guides Pure Global Mexico Services

Key Dates & Milestones

Guide UpdatedOctober 2025

Abbreviated Pathway EffectiveSeptember 1, 2025

Pure Global Mexico ServicesActive Now

Pure Global MRH Pricing

Low Risk (LR)

$1,000 - $2,000

Class I Devices

$3,000 - $4,000

Class II/III Devices

$5,000 - $7,000

Includes:

✓ Classification verification
✓ Spanish translation
✓ COFEPRIS submission
✓ Query response management

MRH Selection Checklist

Essential Criteria:

☐ Published pricing transparency
☐ Local Mexico office presence
☐ Independent (not distributor)
☐ 5+ years COFEPRIS experience
☐ Spanish/English fluency
☐ Abbreviated Pathway expertise
☐ Client references available

✅ Pure Global meets all criteria

DJ Fang

MedTech Regulatory Expert

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Pricing

Free consultation

Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on Choose a Mexico Registration Holder (MRH) official documentation