Case Study 36: Regulatory Support for Visual Electrodiagnostic Testing System in Mexico and Brazil

Company Situation

The Client is a leading US based manufacturer of visual electrophysiology products used for the diagnosis of retina and optic nerve disease. The products are approved in US as a Class II and III device. The machines are completely portable, handheld, full field flash ERG and VEP testing device for both human and veterinary purposes. Client is seeking a partner to support with the regulations in Mexico and Brazil. Since the products had to be registered according to COFEPRIS’ and ANVISA regulations, GRP assisted with a strategic approach from device classification, to preparation and submission of regulatory documents and acted as legal regulatory representation for the client.

GRP Solution

GRP has significant experience in handling medical devices in Mexico and Brazil. GRP did a thorough planning of each steps considering the timelines the client was aiming the launch. GRP provided comprehensive strategic inputs to Client to enable its successful registration in Mexico and Brazil using following methods:

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Mexico's Cofepris

COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios is a decentralized and autonomous body run by a commissioner appointed by the President of Mexico and regulates health facilities, advertising activities, and the manufacturing, import, or export of health products.