Brazil’s ANVISA Streamlines Medical Device Importation Processes

EMERGO SUMMARY OF KEY POINTS:

• A new ANVISA resolution has simplified medical device importation requirements for Brazil.
• Imported devices no longer have to undergo inspections at Brazilian points of entry.
• Additional changes to simplify ANVISA importation requirements are anticipated in the near future.

Brazilian medical device market regulator ANVISA has simplified importation regulations to ease market entry for foreign manufacturers commercializing in the country.

Among other changes, ANVISA Resolution RDC 208/2018 (link in Portuguese) removes requirements that devices imported into Brazil must undergo inspection at sites where they receive product clearance, which should result in faster time to market for affected importers.

RDC 208/2018: Impact on medical device importers

Other important changes in the new resolution include:

• Changing deadlines for responses to importation queries to 30 days
• Labeling requirements that now differentiate information according to product class
• Device imports no longer require authentication and signature recognition following implementation of electronic signing and petitioning processes
• Importers must no longer link MERCOSUR Common Nomenclature (NCM) to particular procedures

Bottom line

According to Luiz Levy, Director of QA/RA at Emergo in Brazil, RDC 208/2018 will benefit foreign medical device manufacturers entering the Brazilian market in terms of time and cost.

“This is a great change that simplifies the importation process, helps reduce importation timeframes and reduces costs associated with importation,” Levy says. “We anticipate additional steps from ANVISA in the near future to simplify import licensing requirements using a risk-based approach, which should further benefit foreign manufacturers with good compliance histories.”

Related Brazilian medical device regulatory resources from Emergo:

• Brazil ANVISA medical device registration consulting
• Brazil Registration Holder (BRH) in-country representation
• Certificate of Free Sale (CFS) support for medical device exports
• Whitepaper: Medical device registration in Brazil
• Regulatory process chart: ANVISA approval for medical devices