Dr Arthur Brandwood to speak at China’s CIMDR in Xi’An, and AdvaMed Conference in Washington DC this September.
Archives for August 2013
CFDA has recently published an exposure draft of volume (II) medical devices exempted from clinical trial. This draft proposes addition of a further group of devices for exemption from requirements for local clinical trials.
Korea’s Ministry of Food and Drug Safety (MDFS, former KFDA), announced some important changes to the Medical Device Act early in July. Specifically, the Act highlights amendments to the “Regulations on Classification and Grades”, “General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipments”, and “Regulations on Review, Approvals and Register Notice”.
China’s Centre for Medical Device Evaluation (CMDE) recently revised the requirements for submitting supplementary information in support of registration applications for domestic Class III and imported medical devices.