This is a case study explaining Artixio’s Successful Registration of Dental Implants in Mexico
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.
Determine Classification: The team determined the classification of each dental implant according to the risk-based classification system established by COFEPRIS1.
Prepare Documentation: The team prepared the required documentation, which included manufacturer information, device description, technical documentation, clinical data, labeling and Instructions for Use (IFU) in Spanish, quality management system documentation, and regulatory documents1.
Appoint an Authorized Representative: As the client was a foreign manufacturer, Artixio acted as the authorized representative in Mexico1.
Submit Application: The team prepared and submitted the application for registration to COFEPRIS1.
Review and Evaluation: COFEPRIS reviewed the submitted documentation and evaluated the compliance of the device with regulatory requirements1.
Inspections and Audits: COFEPRIS conducted inspections or audits of the manufacturing facilities to verify compliance with quality and safety standards1.
Outcome: With Artixio’s expert guidance, the client successfully registered all their SKUs with COFEPRIS, enabling them to expand their market reach in Mexico. This case underscores Artixio’s commitment to helping medical device companies navigate complex regulatory landscapes and achieve their business objectives.
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