ANVISA improves timeframes for medical device market applications
According to an analysis of data from the Brazilian Health Surveillance Agency (ANVISA) performed the Medical Device Consulting EMERGO, Brazilian regulators for the medical device market have reduced timeframes in 2015 for responding to and processing submissions from registrants of some medical device market applications.
Throughout most of 2015, ANVISA was able to provide initial responses to 99 percent of market applicants within 90 days of submission. ANVISA’s success rate (90 days) applied mainly to new applications. In cases where the regulator requests additional information from Brazilian market applicants, the 90-day target response time once applicants provide additional information was met at lower percentages throughout 2015.
In terms of number of days it actually took ANVISA to respond to additional information provisions, the agency did perform better for most of 2015 than in previous years, but did not meet its 90-day target in any given month last year.
ANVISA also published data showing total numbers of medical device applications submitted to the agency over the course of 2015. The biggest category of submissions, “materials” that include implants, syringes and catheters saw a marked decline in volume.