03 February 2012
The European Commission is looking at "immediate measures" to improve the surveillance of medical devices within the existing legal framework in light of the sub-standard PIP breast implants affair.
The commission will launch a discussion with all ...
03 February 2012
The European Commission has published a new EU Guideline for Authorised Representatives on its website. The guideline, MEDDEV 2.5/10 of January 2012 , represents the first single, collated document to shed light on the role of the authorised ...
02 February 2012
The French government has published a comprehensive report on the history, current situation and implications of the crisis involving fraudulent silicone breast implants made by the now-defunct Poly Implant Protheses (PIP).
Among the most ...
02 February 2012
US medtech industry association AdvaMed has reached a tentative user fee agreement with the FDA in which companies would pay the agency twice as much to have their products evaluated, in exchange for a faster and more predictable review process.
The ...
01 February 2012
The Kenyan Pharmacy and Poisons Board has issued guidance explaining the current minimum requirements for advertising and promoting drugs and medical devices in the country. The guideline stipulates, among other things, the procedures that ...
