Case Study 35: Regulatory Strategy, Gap Analysis, Classification and Registration of Cosmetic medical devices in Mexico

Company Situation

The Client is a Canada based manufacturer of iontophoresis-based medical devices machine used to treat excessive sweating of underarms, hands and feet. The product is approved in Canada as a Class II device. The machine is a non-invasive, drug-free, and needle-free treatment option that effectively treats excessive sweating. Client is seeking a partner to do the same in Mexico. Since the products had to be registered according to COFEPRIS’ regulations, it required a holistic strategy right from device classification, to review of technical files and further regulatory submissions and acting as legal regulatory representation and license holder for the client.

GRP Solution

GRP has significant experience in handling medical devices of similar categories. 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 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.