Category: Regulatory

RDC 978/2025 for Brazil clinical laboratories: timeline, service types, licence, technical lead, distribution centres, proficiency testing and in-house LDTs.

IVD risk classification in Brazil under RDC 830/2023: the four classes, Annex I rules and how the class drives notification, registration, CBPF and reliance.

An introductory guide for manufacturers and biotechs who want to understand the path before taking the first step. Brazil is big — but getting in the wrong way is expensive If you have a molecular diagnostic product and are thinking about entering the Brazilian market, you have probably heard that Brazil is the largest diagnostics…