Jan 14, 2016

Brazilian medical device market regulators have reduced timeframes in 2015 for responding to and processing submissions from registrants, according to an Emergo analysis of data from ANVISA.

Throughout most of 2015, ANVISA was able to provide initial responses to 99% of market applicants within 90 days of submission, suggesting that the regulator’s initiative to cap application reviews at 90 days, first reported by Emergo in 2013, is succeeding. Improved, more consistent response times were reported both for lower-risk cadastro and high-risk registro applications.

Additional information requests still off target

ANVISA’s success rate applied mainly to new applications, however; 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 and much less consistent percentages throughout 2015. At best, ANVISA was able to respond within 90 days to additional information provisions 62% of the time in July 2015, while at worst the agency could meet its 90-day target 10% of the time in January 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.

Decline total number of submissions

ANVISA has also recently 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 between mid and late October 2015, at the same time that a raft of new regulations took effect and following a steep increase in ANVISA registration and Brazilian Good Manufacturing Practice (BGMP) fees. However, not enough context is provided by ANVISA to determine how these new regulations and fees may have affected submission volumes.


  • Stewart Eisenhart