Brazil’s ANVISA Doubles Validity Timeframes for High-Risk Medical Devices and IVDs
EMERGO SUMMARY OF KEY POINTS:
- ANVISA has extended Class III and IV medical device and IVD registration validity times from five to 10 years.
- These changes have already gone into effect in Brazil.
- ANVISA registrants that have already obtained registration renewals will automatically qualify for the extended validity timeframe.
Brazilian medical device regulator ANVISA has extended the validity of higher-risk device and IVD registrations from five to 10 years, a major and auspicious change for manufacturers selling in the country.
The regulator issued RDC 211/2018 and RDC 212/2018 (link in Portuguese) establishing the new timeframes for Class III and Class IV device registrations. The new regulations also address registration renewals already submitted to ANVISA before the new timeframes were announced.
Effects for ANVISA registrations already renewed or in process
According to RDC 211/2018, Class III and IV device registrations granted by ANVISA prior to the new requirements are automatically extended to 10 years. Registration renewals currently under review by the agency will be closed so that companies may resubmit their renewals to qualify for the 10-year validity timeframe.
Emergo consultants in Brasilia and Sao Paolo are attempting to confirm with ANVISA whether companies that have submitted registration renewals before the agency’s validity timeframe change came into effect will be eligible for refunds.
Bigger picture: Lower barriers to Brazilian market entry
ANVISA’s latest change to Class III and IV registration validity timeframes, following the agency’s recent moves to ease importation requirements, low-risk device registration requirements and Brazilian Good Manufacturing Practice (BGMP) certification rules, show a sustained regulatory effort to lower or remove hurdles to market access.