NOM-241 Overview — GMP for Medical Devices
Overview of NOM-241-SSA1-2025, Mexico's Good Manufacturing Practices standard for medical devices — scope, key requirements, and 2025 updates.
GMP Requirements
Core Good Manufacturing Practice requirements under NOM-241-SSA1-2025 — design controls, CAPA, complaint handling, warehousing, and technical agreements.
COFEPRIS Inspections
How COFEPRIS conducts GMP inspections of medical device manufacturers, importers, and distributors in Mexico — types, authority, and how to respond to findings.
CAPA & Complaint Handling
Corrective and Preventive Action (CAPA) requirements and complaint handling under NOM-241-SSA1-2025 for medical device manufacturers and MRHs in Mexico.