Brazil ANVISA: Half of Some High-risk Medical Device Registration Submissions Rejected in 2016
EMERGO SUMMARY OF KEY POINTS:
- Brazilian regulators rejected nearly half of all registration applications for some high-risk medical devices in 2016.
- ANVISA rejected 14% more “material registro” applications in 2016 than in 2015.
- Fewer medical device and IVD registration applications were submitted to ANVISA in 2016 than in previous years, due to economic as well as regulatory factors.
Nearly half of some higher-risk registro registration applications to Brazilian medical device regulator ANVISA were rejected in 2016, according to the agency’s own performance report.
ANVISA’s report (link in Portuguese) notes that only 54% of Class III and IV “material” devices such as cardiovascular stents, implants and high-risk wound dressings were approved by the agency last year. This and related statistics found in the report suggest significant challenges for manufacturers whose Brazilian market pathways require material registro approvals.
High-risk device applicants face challenging approval odds
According to the report, 46% of material registro applications submitted to ANVISA were rejected in 2016; that rate of rejection of these application types represents a 14% increase compared to 2015.
But material registro applicants weren’t the only ANVISA registrants facing increased challenges to approval. Manufacturers of higher-risk IVDs also saw an increased likelihood of rejection in 2016: Their rate of rejection for IVD registro applications last year was 33%, up from 30% in 2015.
These rejection rates may indicate that Brazilian market applicants—or at least those whose devices fall under the material registro category—attempting to deal with ANVISA on their own are less likely to obtain approval than firms that utilize third-party partners that have some familiarity with Brazilian regulatory processes and requirements. (As an example, material registro applicants who partnered with Emergo in 2016 saw a 95% approval rate.)
Average ANVISA review and approval times
ANVISA included average timeframes for reviewing and approving medical device and IVD registration applications for both material and equipment classifications in the report:
- Cadastro (low risk) material: 136 days
- Cadastro equipment: 99 days
- Registro material: 400 days
- Registro equipment: 104 days
- Registro orthodedic implants: 173 days
- Cadastro IVD: 172 days
- Registro IVD: 218 days
As the report shows, the two categories that warrant the longest review times, registro material and registro IVD, also show the highest ANVISA rejection rates.
Decrease in number of medical device registration submissions
The overall number of medical device registration applications to ANVISA for cadastro and registro approvals as well as for device modifications and revalidations fell by 36%, from 17,846 in 2015 to 11,383 in 2016.
Why? According to Luiz Levy, Director of QA/RA at Emergo’s Sao Paolo office, a combination of broader economic factors as well as regulatory issues drove these numbers down last year.
“Most of these reductions were due to Brazil’s economic situation and market factors in 2016, but we also saw decreases as a result of regulatory changes,” Levy explains. “In part, numbers of submissions fell because of the publication of RDC 40/2015 and RDC 36/2015, which removed the requirement to submit registration renewals for lower-risk devices.”
By removing those requirements, Levy adds, ANVISA could refocus its resources on reviewing other types of market applications in order to begin complying with Law 6360, which established new and shorter timeframe requirements for application reviews by the regulator.
More regulatory resources for the Brazilian market
For more in-depth coverage of Brazil’s medical device and IVD regulations, watch our video overview of ANVISA’s registration process, read our whitepapers on Brazilian Good Manufacturing Practice (BGMP) and ANVISA IVD registration, and download our regulatory process chart.