Mexico · Medical Devices

Unique Device Identification in Mexico

A practical guide to Unique Device Identification for medical devices sold in Mexico: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Devices may need a UDI on the label and in the local database; Brands distributing devices through local partners

Authority

COFEPRIS

Legal basis

COFEPRIS device regulations

Local representative

A local licence holder or authorised representative is required

Timeline

Registration can take months; plan early

Cost

Clinical evidence and QMS audits dominate cost

If you do not comply

Import ban, seizure, and enforcement action

Who needs this

Devices may need a UDI on the label and in the local database
Brands distributing devices through local partners

Documents you need

UDI assignment and label artwork
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

UDI assignment and label artwork
Regulatory classification and registration
Clinical or performance evidence
Quality management system certificate

How to comply

Assign UDI codes and update the label
Classify the device under local rules
Prepare technical documentation
Complete registration or notification

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Unique Device Identification — Mexico
Product category: Medical Devices
Authority: COFEPRIS
Legal basis: COFEPRIS device regulations

Documents we already have:
  1. UDI assignment and label artwork
  2. Regulatory classification and registration
  3. Clinical or performance evidence
  4. Quality management system certificate

Questions:
  1. Does our product fall under Unique Device Identification in Mexico?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Registration can take months; plan early.

Clinical evidence and QMS audits dominate cost.

Common rejection reasons

UDI missing from the label
Wrong risk classification
Clinical evidence insufficient
QMS certificate not accepted

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs Unique Device Identification in Mexico?

Devices may need a UDI on the label and in the local database Brands distributing devices through local partners.

What documents are required for Unique Device Identification?

UDI assignment and label artwork; Regulatory classification and registration; Clinical or performance evidence; and quality management system certificate.

What is the first step for Unique Device Identification?

Assign UDI codes and update the label. Registration can take months; plan early.

How long does Unique Device Identification take?

Registration can take months; plan early.

How much does Unique Device Identification cost?

Clinical evidence and QMS audits dominate cost.

What happens if I sell without it?

Import ban, seizure, and enforcement action.

Who regulates Unique Device Identification in Mexico?

COFEPRIS.