Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. The window for applications closes on 22 July
India continues toward implementation of the new Medical Device Regulations with publication of a new classification catalogue for 250 devices and IVDs.
Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need. Is the pendulum starting to swing back?
There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR). We take a look at the lessons to learn from the Australian experience.
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.
On 17th May 2017, China FDA published a draft ‘Exemption List of Local Clinical Trial for Class II & Class III medical devices’. This is open for industry and user feedback with a deadline of 20th June 2017.
This will be the 3rd wave exemption list in China.