COFEPRIS 2026 Modifications Guideline for Medical Devices

The COFEPRIS modifications guideline 2026 provides official instructions for requesting changes to the sanitary registration of medical devices in Mexico. It defines documentation requirements, submission procedures, and responsibilities of manufacturers and registration holders, ensuring compliance with national laws while maintaining product safety, quality, and efficacy.

Overview of Sanitary Registration Modifications

This guideline outlines the criteria, documentation, and procedures required for submitting modifications to medical device registrations. All modifications must be requested by the registration holder using official formats. Documents must be in Spanish or English, and foreign documents require legalization or certified translation. Explanatory letters may be submitted to clarify discrepancies.

General Principles and Definitions

The guideline emphasizes legal compliance and defines key roles:

• Manufacturer, legal manufacturer, and actual manufacturer responsibilities

• Modifications must follow current legislation, including the General Health Law, Regulation of Health Supplies, and Pharmacopoeia supplements

• Letter of Representation is required if the product is not manufactured by the applicant’s company

Documentation and Supporting Information Requirements

Applicants must submit complete, valid, and verifiable documents:

• GMP certificates: Current, legalized/apostilled, and translated if foreign. Equivalent documents such as ISO 13485 or CE certificates are accepted.

• Certificates of Free Sale: Authenticated, current, and including product details. Equivalents from FDA, Health Canada, MHLW, or WHO prequalification may be used.

• Certificates of Analysis: Must specify parameters, results, and standards compliance.

Modifications that affect safety, efficacy, or intended use require submission of a new registration.

Types of Modifications and Procedures

Immediate Resolution (Certificate of Filing)

Includes:

• Address changes

• Distributor additions

• Packaging updates

• Deletion of presentations or manufacturers

Requirements: modification forms, proof of payment, draft labels, official letters.

Review Procedures (Resolution Letter)

Includes:

• Company name changes

• Manufacturer responsibility changes

• Product name corrections

Required: official forms, proof of payment, labels, and legal endorsement documents. Some modifications, like eliminating a legal manufacturer, require administrative procedures.

Specific Requirements for Address and Distributor Changes

• Address changes: modification form, payment proof, draft labels, legal endorsement

• Distributor changes: modification form, payment proof, draft labels, Letter of Representation

• Rights fees: 50–75% depending on risk classification and modification type

• Documents must be properly formatted, legalized, and translated

Critical Data and Additional Considerations

• Validity of GMP and Free Sale certificates: generally 30 months

• Electronic documents must be verifiable via official platforms

• Modifications affecting safety or intended use require a new registration

• Changes in company name, responsible manufacturer, or product name must be legally documented

• International equivalency accepted: FDA, Health Canada, MHLW

Letter of Representation Requirements

• Endorses the new importer/distributor

• Can be original, certified copy, or simple copy

• Foreign letters must be notarized and translated into Spanish

• May cover multiple procedures with proper cross-referencing

• Additional supporting documents: manufacturer notification of name change, legal endorsement

Key Modification Scenarios

Change of Manufacturer Responsible for Quality

• Form FF-COFEPRIS-15, 75% rights fee, legal justification, Letter of Representation

Change or Inclusion of Device Name or Catalog Number

• Form, payment, manufacturer’s justification letter, no deletion of catalog numbers

Spelling Corrections

• Form, payment (50–75%), letter from health manager

Change of Manufacturer Domicile

• Form, payment, legal proof, GMP, analysis certificates, Free Sale certificate

Assignment of Rights

• Form, payment (50–75%), draft labels, legal transfer documents, Letter of Representation

• Notification within 30 working days

Technical Modifications

• Includes changes to manufacturing site, materials, formula, sterilization, software, risk reclassification

• Documentation: GMP, analysis certificates, stability studies, technical reports, software validation/cybersecurity

General Legal and Administrative Requirements

• Legal representative accreditation (Power of Attorney or RUPA) required for all modifications

• Legal documents: apostilled, authenticated, or digitally signed

• Electronic signatures and official website verification accepted

• All documents must be valid and properly authenticated

Conclusion

The COFEPRIS modifications guideline 2026 provides a structured and compliant approach for managing medical device registration changes in Mexico. By defining procedures, documentation standards, and legal obligations, the guideline ensures all modifications maintain product safety, quality, and efficacy while aligning with national regulations.

Internal Links

• Learn more about COFEPRIS Mexico Medical Device Registration

• Related: Mexico COFEPRIS 2025 Abbreviated Pathway for Medical Devices

External Links

• Official COFEPRIS Modifications Guideline PDF