EMERGO BY UL SUMMARY OF KEY POINTS:

  • Brazilian regulators have published RDC 270/2019 establishing a notification pathway for Class I medical devices and IVDs
  • Qualifying low-risk medical devices will not undergo full ANVISA registration.
  • Implementation of notification pathway set for May 2019.

Brazil’s medical device regulator ANVISA has issued a new regulation for a “notification” market pathway providing streamlined market access for low-risk devices .

ANVISA regulation RDC 270/2019 (link in Portuguese) will go into effect in May 2019. Under the notification pathway, Class I devices will not be required to undergo full cadastro registration and approval, providing faster access to the Brazilian market for qualifying products.

ANVISA notification requirements and review

Once ANVISA’s notification regulation is implemented, applicants’ documentation obligations will be similar to existing Class I cadastro requirements, which include technical dossiers and ANVISA application forms. Applicants must also provide proof of relevant certifications such as INMETRO and ANATEL.

Once submitted, Class I device applications will not undergo technical reviews; instead, such devices will be notified to ANVISA once applications and fees have been received by the agency. The regulator intends to issue notification numbers to applicants within 30 days of receipt of submissions.

ANVISA plans to publish Class I notifications only on its own website, not in the Official Diary. Manufacturers may begin marketing their devices in Brazil once they have received notification numbers and added them to their product labeling.

Maintaining ANVISA notifications

Manufacturers of notified Class I devices should be aware that ANVISA may cancel their notifications at any time due to lack of proper documentation, incorrect classification or complaints.

In addition:

  • Modifications to notified devices will be allowed once applications and fees have been submitted to ANVISA;
  • 180-day limited stock depletion period requirements will no longer apply to Class I devices (ANVISA has changed stock depletion rules so that Class I and II medical devices and IVD manufacturers may commercialize both versions of their products until the prior versions of these devices' shelf lives expire);
  • RDC 270/2019 automatically impacts registration transfers, so once the regulation goes into effect, ANVISA will not allow transfers of notifications, requiring manufacturers to re-notify using new Brazilian Registration Holders (BRH);
  • Class I device notifications will not expire.

"This new regulation will help ANVISA to continue its effort to focus on higher-risk medicald devices considering that Class I device applications represent more than 30% of submissions to the agency," explains Luis Levy, Director of RA/QA at Emergo by UL in Brazil. Levy adds that RDC 270/2019 also aligns with similar rules established by International Medical Device Regulators Forum (IMDRF) member regulators, and allows manufacturers to commercialize their devices faster in Brazil.

"It is important to highlight that RDC 270/2019 requires manufacturers to maintain strong regulatory teams and partners in order to properly assess their device classifications and certifications to ensure they qualify for notification, and to avoid future compliance issues with ANVISA since their initial Brazilian market approvals will not depend on ANVISA review," Levy notes.

Updated from a previous post published on February 27, 2019.

Related Brazilian medical device regulatory resources from Emergo by UL:

  • Brazilian ANVISA medical device registration and approval consulting
  • Brazilian Registration Holder (BRH) support for medical device companies
  • ANVISA medical device classification consulting
  • Whitepaper: Brazil’s medical device registration process
  • Video overview: ANVISA medical device registration

Author

  • Stewart Eisenhart