Classification and scope
Assess Class I–III classification using intended purpose, invasiveness and mode of use. Check low-risk lists and any special regulatory provisions.
MX · COFEPRIS
Mexico COFEPRIS registration
Assess classification, the local applicant and Spanish documentation for conventional registration or an applicable equivalence or reliance pathway.
How SUNGO supports your project
Pathway assessment
Review existing reference-market authorisations and consistency of products, manufacturers and models for equivalence or reliance eligibility. Use the conventional route where appropriate.
Local applicant and Spanish dossier
Coordinate local holder and application arrangements. Review authorisations, certificates, labelling, instructions and Spanish administrative and technical documents.
Application and lifecycle support
Support submission coordination, additional information, changes and renewal preparation, while clarifying holder, import and distribution responsibilities.
Equivalence or reliance does not mean exemption from registration. A foreign certificate alone does not establish eligibility; the current COFEPRIS pathway and device-specific conditions must be assessed.
AFTER THE INITIAL DISCUSSION
Build a product-specific document plan
You do not need every document for the first enquiry. We identify gaps after understanding your product and target market.
Intended purpose, models and technical characteristics
Manufacturer and proposed local-applicant details
Overseas authorisations and their product scope
Quality-system and performance evidence, plus Spanish labelling readiness
Specific requirements are subject to product assessment and the competent authority’s current regulations.
COFEPRIS · Device registration routes ↗ · COFEPRIS · Registration guidance ↗
Service process overview
- 01
Confirm classification and pathway
- 02
Prepare application documents
- 03
Submit the application
- 04
Respond to review enquiries
- 05
Receive the relevant documents upon approval
Specific requirements are subject to product assessment and the competent authority’s current regulations.
INITIAL CONSULTATION
Start with two things
Send your product name and instructions for use, and tell Serena which market you are considering.
- Product name
- Instructions for use