Registration of In-Vitro Diagnostic (IVD) Device in Brazil

An US-based Biotech company manufacturing fungal detection IVDs had approached Freyr to provide registration services to launch their product in Brazil. As the client was registering their devices with ANVISA for the first time, they had challenges in determining the registration pathways, getting a BGMP certification and translating the required documents into Portuguese. Freyr supported the client by providing legal representative services and responded to the Agency’s queries on time.

Download the proven case to understand how Freyr diligently optimized the data requirements as per the ANVISA requirements and successfully registered the device in Brazil.


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