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From China to Brazil: Navigating ANVISA without NMPA Reliance

From China to Brazil: Navigating ANVISA without NMPA Reliance

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 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 devices in Brazil? • Why is a Brazilian Registration Holder (BRH) mandatory for foreign manufacturers? • Do all medical devices require a Brazilian Good Manufacturing Practice (B-GMP) certificate? • What is the key regulation that governs medical device classification and registration in Brazil? • What are INMETRO and ANATEL certifications, and when are they required? • What is the difference between the *Notificação* and *Registro* pathways? • Does having MDSAP certification replace the need for a B-GMP audit? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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