Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Brazil’s ANVISA reports higher volumes of medical device market application submissions for the first half of 2018.
- Increased submission volumes are mostly for lower-risk medical devices and IVDs.
- ANVISA was able to respond to most cadastro and registro market applicants within a 90-day time frame, according to the six-month results.
Brazilian medical device regulator ANVISA has issued a performance report for the first half of 2018 showing small but consistent improvements in marketing application review times as well as higher volumes of applications submitted compared to mid-2017.
The ANVISA report (link in Portuguese), analyzed by Emergo’s São Paulo office, covers the agency’s six-month performance regarding review timeframes, application rejection rates and related indicators. Results of the report should be considered in the context of ANVISA’s ongoing efforts to streamline and boost market access in Brazil through measures such as:
- Easing market access for low-risk devices;
- Increasing manufacturer interest and participation in the Medical Device Single Audit Program (MDSAP);
- Doubling validity timeframes for higher-risk medical devices and IVDs;
- Streamlining Brazil’s medical device importation requirements.
Higher volumes of ANVISA registration applicants
First, the report shows that the total number of Brazilian market applications submitted to ANVISA between January and June 2018 increased slightly compared to 2017: 1,592 applications per month were submitted to the regulator in the first half of 2018, a five-percent increase over the same time period last year. Furthermore, ANVISA was able to complete analysis of and publish 1615 applications over the past six months, a two-percent increase compared to 2017.
“The majority of new applications submitted were related to lower-risk devices,” observes Luiz Levy, Director of RA/QA at Emergo in Brazil. “This makes sense due to the complexity and significant amount of investment necessary for submitting applications for higher-risk devices, and also because the majority of devices marketed in Brazil are classified as Class I or Class II.”
Levy also notes that numbers of submissions pertaining to registration transfers increased, which he suggests may be associated with the effects of RDC 102/2016 allowing transfers of approved registrations between Brazil Registration Holders (BRH) without preexisting corporate relationships. On the other hand, there was also an increased number of cancellation applications submitted, which may be linked to economic factors.
Response times: faster for medical devices than IVDs
ANVISA’s report also shows that the regulator’s responses to applicants’ requests—either by approving applications, requesting more information or rejecting applications—fell within the 90-day timeframe set by Law 6360/1976 for most lower- (cadastro) as well as higher- (registro) risk devices. ANVISA was only able to respond to 65% of such requests from IVD registro and cadastro applicants during the first half of 2018, on the other hand.
Overall, though, between 2016, 2017 and the first six months of 2018, ANVISA has clearly made strides in reducing cadastro and registro application review times, according to the report. Average number of days for evaluation of cadastro applications has fallen from 162 in 2016 to 126 in 2017, and now to 91 so far in 2018; for registro applications, average review times have been reduced from 400 in 2016 to 255 in 2017 to 194 in 2018.
Rejection rates: materials, equipment and IVDs
Rates of rejection for cadastro versus registro market applications have depended on which division of ANVISA reviewed submissions for the first six months of 2018, according to the report.
For submissions evaluated by GEMAT, which reviews material (e.g., stents, catheters) applications, rejection rates were higher (about 45% month-to-month) for registro applications. (Rejection rates for cadastro applications and modification submissions were about 20% and 10 to 15%, respectively, over the same time period.)
“Rejection rates for higher-risk device applications reviewed by GEMAT are historically higher,” says Levy. “This is because of the more comprehensive documentation requirements for these submissions. Clinical data requirements for applicants from the European Union, are particularly challenging as the requirements are not aligned and this becomes critical for novel devices.”
Results pertaining to submissions reviewed by GQUIP, the ANVISA division covering equipment (e.g., ECGs, ophthalmic laser) applications, skew in the opposite direction. For most of the past six months, GQUIP rejections primarily comprised cadastro submissions by an average of 25%.
Although rejection rates for lower-risk IVD applicants reached 25% at the beginning of 2018, those rates stabilized at 10-15% for the remaining first half of the year. Higher-risk IVD applications averaged a 12% rejection rate for most of the first half of the year, but reached 20% in May.
Third-party consultant support improves ANVISA review processes
While ANVISA continues to add efficiencies and streamline more complex requirements of medical device and IVD registration in Brazil, foreign manufacturers applying for Brazilian market access still face considerable expenses and challenges.
Based on Emergo’s experience and track record supporting ANVISA market applicants in Brazil, partnering with third-party regulatory consultants may improve applicants’ changes of avoiding rejection and successfully obtaining approval to sell their devices in the country.
So far in 2018, rejection rates for IVD applications submitted by Emergo on clients’ behalf have have a zero-percent rejection rate, for example. GEMAT material reviews of Emergo submissions have resulted in a five-percent rejection rate for cadastro applications and a 14% rejection rate for registro applications, well below the average percentages reported by ANVISA. GQUIP equipment reviews of Emergo submissions have yielded an eight-percent rejection rate for cadastro applicants and zero percent for registro applicants so far in 2018.