EMERGO SUMMARY OF KEY POINTS:

• ANVISA intends to move medical device registration validity timeframes from five to 10 years.
• Expanded validity timeframes should result in lower ongoing compliance costs for Brazilian market registrants.
• The ANVISA proposal will undergo finalization following a 60-day comment period.

ANVISA, Brazil’s medical device market regulator, has proposed extending validity timeframes for registered products under its jurisdiction for up to 10 years.

According to a new public consultation published by ANVISA, the agency will begin a 60-day comment period starting August 8, 2017; interested parties may submit comments and suggestions electronically (links in Portuguese).

Emergo consultants in Sao Paulo report that the ANVISA proposal would reduce Brazilian market registration costs particularly for companies selling or planning to sell Class III and IV medical devices in the country. ANVISA device registrations are currently valid for five-year periods. The new public consultation would extend that timeframe to 10 years, significantly lowering registrants’ renewal costs and associated compliance requirements.

Following the 60-day comment period, ANVISA will finalize the text of the proposal so that it may become regulation.

Additional information on Brazilian medical device regulations from Emergo:

• ANVISA registration support for medical device companies
• Brazilian Good Manufacturing Practice (BGMP) quality system compliance services
• White paper: Brazilian medical device market registration
• ANVISA regulatory process chart