ANVISA Launches Medical Device Monitoring Program in Brazil
Medical device market regulators in Brazil have formally launched a new system for monitoring medical devices registered for sale in the country.
ANVISA’s new program, the National Program for the Quality of Medicines (Proveme), will monitor drugs as well as devices such as orthopedic and breast implants available on the Brazilian market. Under the program, ANVISA laboratories will be authorized to analyze samples of devices and submit reports to a new database, SGAWeb, that regulators began developing in 2011.
Along with the Proveme system, ANVISA has also established a new unit, the Management Center of Information on Health Surveillance Emergencies (eVISA), which will be responsible for managing the monitoring of and response to drug- and device-related health emergencies in Brazil.
Impact on ANVISA registrants?
For medical device manufacturers registered in Brazil, the new monitoring program seems to have little direct impact. Registration and BGMP quality system compliance requirements remain the same. Post-market vigilance and surveillance processes may be more affected as the new program rolls out, but that remains to be seen.