The World Health Organization's inaugural Global Forum on Medical Devices, which began on 9 September in Bangkok, Thailand, promises a breakthrough in improving access to medical technology globally...
The UK Medicines and Healthcare products Regulatory Agency has reported that the preliminary tests it has conducted on the silicone filler used in banned breast implants made by Poly Implant Prothèse...
Orthopaedics firm DePuy has voluntarily recalled two of its hip replacement products, after post-market surveillance data showed a high risk of revision rates for patients implanted with the devices...
The International Organization for Standardization has published a new technical report that provides a comprehensive, globally harmonised methodology for classifying nanomaterials 1 ,2 . The...
The H1N1 influenza pandemic that was declared by the World Health Organization last year has officially "moved into a post-pandemic phase" 1 ,2 . The WHO's director general, Margaret Chan, made the...
The US-based ECRI institute says its Universal Medical Device Nomenclature System will be expanded to include "many additional terms" for software used with medical devices by the end of 2010 1 . The...
The Global Harmonization Task Force has adopted a procedure that will open up membership of the group’s steering committee to representation from outside the European Union, the US, Japan, Canada and...
Sharon Williams discusses the regulatory hurdles for IVDs. The in vitro diagnostics industry represents one of the most lucrative segments in the global healthcare industry 1 . The global IVD market...
A group of medical technology industry associations has become a formalised organisation that aims to ensure the industry’s views are reflected at the global level, among other objectives. The Global...
German health technology assessment institute IQWiG has renewed its call for legislation to make the prospective registration of clinical trials mandatory and to compel trial sponsors to publish the...
The World Health Organization plans to convene the first global forum on medical devices on 9-11 September, in Bangkok, Thailand 1 . The forum is being organised as part of an overall strategy to...
The World Health Professions Alliance is calling for stronger action to be taken to stem the counterfeiting of medical products under a new campaign called “Be aware, take action” aimed at the...
Participants at the 2010 International Medical Device Industry Compliance Conference examined this hot issue from all angles, reports Karen Finn . Medtech companies are aware that they need to...
Critical biocompatibility tests that French regulatory agency Afssaps is conducting on the unauthorised silicone filler that was used in thousands of breast implants made by Poly Implant Prothèse...
The heightened emphasis on global compliance in the medtech industry has reached such a fever pitch that compliance officers are now referring to themselves as the company’s “designated felon”....
