Korea MFDS has flagged intentions to allow fast track access for 3D printed devices in humanitarian cases, and to expedite introduction of new regulations for 3D printed devices by November 2016.
Archives for May 2016
The European Union finally agreed late Wednesday Brussels time on a final text for the long awaited European Device regulations. Agreement of course is subject to approval by other players in the EU political process, but it does look as though we are reaching the end of the journey in the long awaited updates to the MDD/AIMD/IVDD Directives. The long telegraphed increases in rigour of inspection, post market monitoring and unannounced inspections are all included.
FDA has published a detailed draft guidance on regulation of 3D printed devices. Offering detailed advice on both design and manufacturing and on device testing, the guidance exposes the agencies “initial thinking” on regulatory controls for 3D printed devices. What is a “Leap Frog Guidance anyway? Read on…
The 2015 CFDA annual report suggests registrations are falling – but all is not what it seems…. Read More.
As regulations tighten – regulators get busier and backlogs and delays are increasing. In this environment, a single audit program not only reduces audit workload – it can offer speedier market access.
Regulators the World over have been toughening up on the requirements for clinical evidence of safety and performance of medical devices. More devices are required to have direct clinical trial data, and where literature based evidence is accepted, the standards are getting tougher. China’s CFDA strengthened clinical evidence requirements as it revamped regulations over the past two years and Australia’s TGA currently has a new Clinical Evidence guidance out for consultation. We take a look, the international similarities are striking.