Accelerate market access with expert regulatory support for medical devices, IVDs, and combination products. At Althian, we provide specialized regulatory consulting for the classification, registration, and approval of medical devices, in vitro diagnostics (IVDs), and combination products across Mexico and Latin America. Our bilingual team of experts guides sponsors, CROs, and manufacturers through every step of the regulatory pathway—from initial classification to dossier preparation and submission to COFEPRIS and other regional authorities.

Product Classification & Regulatory Strategy

• Determination of product type and classification based on COFEPRIS, IMDRF, and international standards.

• Strategic pathway selection: simplified registration, equivalency route, or full dossier submission.

• Regulatory intelligence to align with evolving LATAM frameworks and global harmonization efforts.

Technical File Preparation & Dossier Development

• Compilation and formatting of technical documentation: risk analysis, clinical evidence, labeling, and manufacturing data.

• Preparation of regulatory dossiers in compliance with NOMs, ISO standards, and COFEPRIS requirements.

• Bilingual documentation support (Spanish-English) for cross-border submissions and global sponsors.

Registration Submission & Follow-Up

• Submission of registration packages to COFEPRIS and other LATAM health authorities.

• Response to authority queries, deficiency letters, and technical clarifications.

• Coordination of post-submission follow-up, renewals, and modifications.

Lifecycle Management & Compliance

• Support for product updates, labeling changes, and reclassifications.

• Advisory on vigilance reporting, post-market surveillance, and regulatory maintenance.

• Integration with pharmacovigilance and quality systems for combination products.