ANVISA manages better with reduced timelines for medical device market applications

Brazilian Health Surveillance Agency (ANVISA) has reduced timeframes in 2015 for acknowledging and undertaking submissions from registrants of medical device market applications. Throughout most of 2015, ANVISA could effectively manage to provide initial responses to 99% 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 extra information from Brazilian market applicants, the 90-day objective response time once applicants provide extra 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 performed better for most of 2015 than in previous years, but could not meet its 90-day target in any given month in 2015. 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.



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