Case Study 38: Regulatory Support for Innovative SmartPen with AI Technology in Brazil.

Company Situation

The Client is a US based manufacturer of innovative kit devices with accessories for ENT examination, transmission of real time lungs and heart rates and measuring body temperature. It would perform entirely using electronic and telecommunication software and internet. The kit consists of a smart pen with a digital otoscope, Stethoscope and Thermometer.

The devices require Wi­Fi connection with Android, iOS and Windows for data communication (Video, Audio and temperature measurement) and USB connection with Windows for data communication (Video, Audio and temperature measurement. Client was seeking a partner to support with the regulations in Brazil. Since the products had to be registered according to ANVISA regulations, GRP assisted with a strategic approach from device classification, to preparation and submission of regulatory documents and acted as legal representation and also helped in attaining the ANATEL Homologation Certificate for the client.

GRP Solution

GRP has significant experience in handling medical devices with AI technology in 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 Brazil using following.

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more Resources:

GRP whitepaper: Homologation of medical Devices by Brazil's ANATEL

Medical Devices that use functionalities such as Bluetooth, Wi-Fi and other wireless connectivity features require ANATEL registration is required as part of the registration process of devices as per the new Brazilian medical device regulations. ANATEL certification as a component of registration and modification applications for devices used for telecommunication as well as for devices using radio