At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force (GHTF)) a...
An online system for the reporting of problems associated medical devices (adverse event reports) is now available to industry and consumers. The Therapeutic Goods Administration’s (TGA) new reporting system consists...
The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The document is aimed at ensuring the...
Brazil’s regulatory agency, Anvisa, has introduced reforms to simplify classification processes for IVD products. From the 18th of May 2012 IVD manufacturers will be subject to new regulations which are...
The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, released on 1 July 2010....
The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and...
On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a...
The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers. The regulatory bodies ANMAT (Argentina),...
The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. The reforms are...
IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 60601 group...