Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 23 March 2012 | By Alexander Gaffney, RAC
Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global scandal, reports Reuters.
"Health regulator Anvisa will require implants to be certified through the national quality control institute Inmetro to ensure products meet new criteria including physical strength, tear resistance and absence of toxic substances," wrote Reuters.
The new certification scheme and controls come after reports that implants manufactured by now-defunct French company Poly Implant Prothese (PIP) were not subject to adequate regulatory oversight, potentially engendering patients around the globe.
Reuters reports "manufacturers will be able to choose between certification through on-going pre-market tests on batches of their products, or on-site inspections of production processes that will come on top of existing factory inspections by Anvisa."
Read more:
Reuters - Brazil tightens quality controls on breast implants
Tags: Inmetro, National Quality Control Instute, South America, Breast Implant, Implant, PIP, Latest News, brazil, certification