Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
COFEPRIS
Register your medical device in Mexico.
Use the abbreviated pathway introduced in September 2025, which accepts FDA, Health Canada and IMDRF approvals for registration in 30 days.
Speak to a specialistThe authority
Comision Federal para la Proteccion contra Riesgos Sanitarios
COFEPRIS
Regulatory authority
Mexico
A decentralised body of the Ministry of Health responsible for the sanitary regulation of medical devices, medicines and food in Mexico.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk | Bandages, masks, gauze |
| Class IIa | Low-to-moderate risk | Simple diagnostic equipment |
| Class IIb | Moderate-to-high risk | Infusion pumps, surgical equipment |
| Class III | High risk | Implants, pacemakers, haemodialysis equipment |
Registration process
How we manage your project
- 01
Authorised importer2-3 months
Establish a Mexican registration in the Padron de Importadores
- 02
Assess the pathway2 weeks
Check eligibility for the abbreviated pathway (FDA/HC/IMDRF)
- 03
QMS3-6 months
ISO 13485 or NOM-241-SSA1-2025
- 04
Technical dossier2-4 months
Prepare Health Registration in Spanish (or through abbreviated reliance)
- 05
COFEPRIS submission1 week
Submit through the electronic portal and pay the fees
- 06
Approval and registrationvariable
Abbreviated pathway: 30-day target. Traditional pathway: 6-12 months
Total timeframeAbbreviated pathway: 30 days. Traditional pathway: 6-12 months
Local representativeMexican authorised importer
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | COFEPRIS technovigilance and adverse event reporting |
| Renewal | Up to 10 years (updated January 2026) |
| Required QMS | NOM-241-SSA1-2025 or ISO 13485 (accepted) |
How HSC helps
Mexico in 30 days through the FDA/Health Canada abbreviated pathway.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about COFEPRIS
Next step
Ready to start your project in Mexico?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist