Obtain a COFEPRIS sanitary registration, using equivalency routes where you qualify.
Classification, registration and equivalency pathways for devices already approved in reference markets, with a Mexican registration holder.
Key facts
Pathways
- Sanitary registration (registro sanitario) for most devices
- Equivalency routes for devices approved by the US FDA, Health Canada or Japan's MHLW
- Low-risk products listed by COFEPRIS as not requiring registration
What you will need
- Technical and scientific information on the device
- Evidence of GMP or ISO 13485
- Spanish-language labelling per NOM-137
- Reference market approvals for equivalency routes
Sequence and decision points
- 01ClassifyApply COFEPRIS classification.
- 02Appoint a holderA Mexican registration holder.
- 03Choose the routeStandard or equivalency route.
- 04SubmitDossier to COFEPRIS with fees.
- 05Register and monitorRegistration, technovigilance and renewal.
GMP per NOM-241-SSA1, shown by inspection or, in some routes, by accepted certificates such as ISO 13485.
A Mexican registration holder with the appropriate sanitary notice or licence holds the registration.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
COFEPRIS fees and review periods vary by route; equivalency routes are usually faster.
After market entry
- Technovigilance per NOM-240-SSA1
- Registration renewal every five years
- Change notifications
How we help
- Classification and route strategy
- Equivalency route assessment
- Dossier preparation support
- Holder coordination
- Technovigilance support
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Mexico
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can our FDA clearance speed up Mexican registration?
Often, yes. COFEPRIS equivalency routes recognise approvals from the US FDA, Health Canada and Japan, subject to conditions.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.