Biosil’s Department of Regulatory Affairs ensures regulatory compliance with appropriate regulations and standards to demonstrate the safety and performance of all products manufactured by Biosil.
In addition, Regulatory Affairs is responsible for obtaining approval from regulatory authorities to sell products in new markets and to maintain registration of products in existing markets.
Biosil manufacture a variety of implants and medical devices that have received CE certification by examination against the requirements of the Medical Devices Directive (93/42/EEC). Further to the Commission Directive 2003/12/EC, Biosil also manufacture a range of gel-filled and saline-fill breast implants that are certified and approved as Class III medical devices in the European Community.
Globally, Biosil have demonstrated compliance with stringent regulatory requirements by successfully achieving registration with authorities in highly controlled markets including the USA (FDA), Australia (TGA), South America (ANMAT & SSA) and Asia (KFDA & SDA).