Regulatory services are a critical supplier – so you should treat them as such and do your vendor assessment and due diligence. What are the key questions you should ask of a potential regulatory adviser?
Archives for May 2013
Arthur Brandwood will be speaking about the regulatory reforms in China at the upcoming AusMedtech Conference on 16th May 2013. The regulatory sessions will also cover the changes in Australian, European, US and ASEAN regulations.
The International Medical Device Regulators Forum (IMDRF) held its third meeting in France on the 19th March 2013. Rapid progress has been made with the UDI and Single Audit program system, while other work items are still a ‘work-in-progress’. China has now taken up full IMDRF membership.
Since the second meeting of the International Medical Device Regulators Forum (IMDRF) in September 2012, the status of the Asian Harmonization Working Party (AHWP) changed from an observer to an affiliate organisation. But the Chair of AHWP, Saudi FDA’s Dr Saleh Al Tayyar, says this is not enough as he continues to argue for a full partnership between IMDRF and AHWP.
TGA proposals for premarket reform include removing the long standing requirement for Australian manufacturers to seek Conformity Assessment directly from TGA, when importers are able to obtain Australian approval based on third party CE certification. TGA also proposes an expansion of the Application Audit program for Class III implantables and Active Implants and publication of regulatory decisions following the AusPAR model used in drug regulation.
The long awaited revision of the Australia-Europe Mutual Recognition Agreement (MRA) sees a relaxation of the Rules of Origin, allowing significant manufacturing steps in third countries. There are also big changes in scope: on one hand lower risk class radioactive devices are now included, and on the other the range of high risk and excluded medical devices has grown substantially. Are you still covered?