EMERGO SUMMARY OF KEY POINTS:

• Appeal timeframes for Brazilian medical device market applicants have been extended.
• ANVISA registration applicants now have 30 days to file appeals to market approval decisions for their devices.
• ANVISA itself now has up to 180 days to evaluate and rule on appeals from medical device companies.

Medical device regulators in Brazil have extended legal timeframes for market registrants seeking to appeal regulatory decisions regarding their applications.

According to RDC 148/2017 (link in Portuguese), a new rule published by Brazilian medical device regulatory agency ANVISA, the extended appeal timeframe will not only allow companies more time to frame their appeals, but also give ANVISA more time to consider and respond to those appeals.

More time for both ANVISA and manufacturers

Essentially, both the agency and Brazilian market registrants will now have three times the amount of days for review decisions and filing appeals. Under current rules (RDC 25/2008), market applicants have 10 days after receiving review decisions from ANVISA to submit their appeals; the regulator then has 30 days to rule on those appeals, with an option to use a 30-day extension.

Under RDC 148/2017, applicants will have 30 days to appeal ANVISA decisions, which should be particularly beneficial in cases where the complexity of a review decision requires more than 10 days to develop an adequate response.

Once ANVISA has received an appeal, the agency will now have a 90-day response timeframe, with an additional 90-day period if justifiable.

Additional information on Brazilian medical device regulation:

• ANVISA medical device registration consulting
• Brazilian medical device regulatory strategy report
• Video overview of ANVISA medical device approval process