Andresa Bastos

Andresa de Oliveira Bastos is a pharmacist with over 18 years of experience in quality management systems and more than 11 years in medical device regulatory affairs.

Regulatory and Quality ConsultantBrazil / Americas1 article

About Andresa Bastos

She specializes in product registration and regulatory compliance with ANVISA, INMETRO, ANATEL, CE Marking, GMP, ISO 13485, and ISO 9001. At Pure Global, she works on medical device registration and quality system implementation projects in Brazil. Her expertise includes a wide range of medical technologies, as well as technovigilance, audits, and certification maintenance.

Prior to joining Pure Global, Bastos held senior roles in regulatory and quality management at Brazilian medical device manufacturers. She holds a degree in pharmacy from Universidade Cruzeiro do Sul and an MBA in Business Management from Universidade de São Paulo, with additional specializations in regulatory affairs and quality systems.

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Blog ArticleJuly 9, 2026

How to register medical devices and IVDs in Brazil

Registering a medical device or IVD in Brazil means navigating ANVISA's dual pathways—faster Notification for low-risk Class I/II devices, or rigorous Registration for higher-risk Class III/IV devices requiring B-GMP certification and technical dossiers. This guide walks through classification, appointing a Brazil Registration Holder, securing necessary certifications (INMETRO, ANATEL, INCQS), and meeting new UDI labeling requirements. It also covers the AREE reliance pathway, which lets manufacturers with existing FDA, TGA, Health Canada, or MHLW approvals potentially cut review times by 30%.