Mar 29, 2012

Brazilian medical device market regulatory ANVISA has announced tighter controls over sales of breast implants in the country following revelations of defective implants manufactured by French firm Poly Implant Prothese (PIP).

According to the INMETRO quality control certification for all breast implant products; implants will be evaluated for physical strength, tear resistance and toxic materials.

ANVISA will allow manufacturer to choose either certification via pre-market testing on batches of their devices or on-site inspections of production processes. On-site inspections of implant production processes will occur separately from routine facility inspections conducted by ANVISA, the Tribune explains.

All new Brazilian market entrants selling breast implants will have to comply with the new rules. As for implant manufacturers already on the Brazilian market, these firms will have to comply once their current five-year device registrations come up for renewal.


  • Stewart Eisenhart