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Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions

Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports progress in meeting review timeframes for medical device and IVD reviews between July and September 2018.
  • ANVISA also reports a spike in modification applications following changes to Brazilian importing and inspection requirements for medical devices and IVDs.
  • Rejection rates for cadastro, registro and IVD submissions over the past three months remain in line with yearlong trends reported by ANVISA.

Brazilian medical device market regulator ANVISA has reported a major increase in medical device modification applications received over the past three months compared to the first half of 2018 following changes to importation and inspection requirements.

A new ANVISA performance report (link in Portuguese), examining medical device and IVD submission data from July to September 2018, shows continuing improvement by the agency in reviewing applications and issuing final decisions or additional requests for market authorizations within target timeframes. However, a majority of applications received by ANVISA during this period (2530) were for device modifications; such submissions totaled 3049 from January to June 2018.

Importation, inspection changes prompting more modification submissions

A key factor behind the increase in modification submissions to ANVISA over the past few months has to do with recent changes to medical device importation and inspection policies in Brazil.

“After changes to importation rules and ANVISA inspection processes, many devices were found to have been labeled with shelf lives inconsistent with information approved in their registrations,” says Luiz Levy, Director of QA/RA at Emergo by UL in Brazil. “This resulted in manufacturers having to submit new modifications to update their device registration information and clear importation hurdles.”

Although ANVISA put measures (link in Portuguese) in place to reduce the impact of importation and inspection changes on manufacturers, these policy changes nonetheless drove up the number of modification applications in recent months, according to Levy.

New ANVISA marketing applications ticking up

Brazilian regulators also reported increased volumes of new registration applications for lower-risk cadastro devices by 20% from July to September compared to April through June of this year, as well as a more modest increase of six percent for submissions pertaining to registration cancellations and transfers. The number of high-risk registro device submissions to the agency, however, declined by six percent over the same three-month period.

Rejection rates for registro and cadastro device applications

As was the case in ANVISA’s previous performance report, rejection rates for registro device applications reviewed by GEMAT, the agency’s division responsible for materials (stents and catheters, for example) were far higher (42%) than for cadastro applications from July to September 2018, which matches GEMAT’s 42% rejection rate for registro submissions for 2018 so far.

Rejection rates for registro applications reviewed by GQUIP, ANVISA’s division overseeing equipment such as opththalmic lasers and electocardiogram equipment), on the other hand, were much lower at three percent—even lower than the division’s nine-percent rejection rate for registro submissions for the year. GQUIP’s rejection rates for cadastro applications, however, reached 18% over the same time period, slightly lower than the unit’s 22% rejection rate for these submissions so far in 2018.

ANVISA rejection rates for IVD submissions from July to September 2018 have stabilized compared to the earlier months of 2018. GEVIT, the ANVISA unit that reviews IVD submissions, reported a seven-percent rejection rate for registro IVD applications between July and September, down from an overall average of 10% for the year so far; rejections for cadastro IVD applications are also down, to 10% for the most recent three-month period versus 12% for 2018 so far.

Emergo by UL’s experience over the past three months helping medical device and IVD manufacturers obtain Brazilian market authorization and approval for modifications suggests that utilizing third-party consultants may reduce the likelihood that companies’ regulatory submissions will be rejected.

  • Emergo’s approval rate for cadastro applications are: IVDs 100%, Materials 97%, Equipment 95%
  • Emergo’s approval rate for registro applications: IVDs 100%, Materials 73%, Equipment 100%
  • Emergo’s approval rate for modifications: IVDs 100%, Materials 97%, Equipment 100%

Review timeframes mostly on target

ANVISA review timeframes for both higher- and lower-risk medical device and IVD submissions continued to meet 90-day legally mandated targets in most cases, the new report shows. That is, within 90-day periods, the agency was able to issue approvals, requests for additional information or rejections for a majority of applications for the July-September 2018 time period.

  • GEMAT completed reviews of 100% of cadastro and 99% of registro submissions falling under its purview.
  • GQUIP completed 99% of cadastro and 93% of registro application reviews.
  • GEVIT completed 77% of cadastro and 78% of registro IVD submission reviews; overall IVD submission review performance has improved 12% since ANVISA’s previous performance report.

Additional Brazilian medical device and IVD regulatory resources:

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