We are pleased to announce that Unimed Medical Supplies Inc. successfully passed Good Manufacturing Practice (GMP) review by ANVISA, and obtained Brazil GMP certification. The Unimed quality management system for medical devices has fully met the requirements of Brazilian regulations.
Unimed has already completed ANVISA registration for ECG Lead Wires and Temperature Probes. Certified with GMP, Unimed is about to finish ANVISA registration for SpO2 sensors to obtain the access qualification for Brazilian market.
ANVISA, Agência Nacional de Vigilância Sanitária, is the medical device regulatory agency of Brazil. Medical devices need to be registered with the Brazilian National Health Inspection Agency (ANVISA) prior to selling legally in Brazil. High-risk medical devices need to firstly obtain Good Manufacturing Practice (GMP) certification and meet the local regulations on medical devices quality management system in order to pass ANVISA registration.