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Case Study: Artixio’s Successful Registration of Dental Implants in Mexico (COFEPRIS)

This is a case study explaining Artixio’s Successful Registration of Dental Implants in Mexico


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Client: A leading global dental implant company

Challenge: The client had a portfolio of over 20 Stock Keeping Units (SKUs) of dental implants that they wanted to register in Mexico. The regulatory body in Mexico, COFEPRIS (Federal Commission for the Protection against Sanitary Risk), has stringent requirements for medical device registration.

Solution: Artixio, with its deep understanding of international regulatory standards and quality management systems for medical devices, stepped in to streamline the process. The team at Artixio worked closely with the client to understand the specifics of each SKU and prepared a comprehensive dossier for each product as per COFEPRIS guidelines.