Latest / Medical Device Global Market Access
From China to Brazil: Navigating ANVISA without NMPA Reliance
This episode clarifies whether a medical device approved by China's NMPA can benefit from an expedited registration process with Brazil's ANVISA. We detail the full Brazilian regulatory requirements, including classification, the role of a Brazil Registration Holder (BRH), B-GMP certification, and the AREE program, explaining why NMPA approval doesn't currently offer a shortcut. • Can my Chinese NMPA approval speed up device registration in Brazil? • What is the AREE program, and which countries does ANVISA recognize for faster review? • What are the two main registration pathways for medical…
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