The China Food and Drug Administration (CFDA) released a draft guidance on September 2, 2016 regarding the medical device recall process. These new measures significantly expand on the current regulations released by the CFDA in 2011. The original regulations defined defective devices as ones that may endanger human health, and focused on establishing a system to keep Chinese processes in line with international conventions. Revisions released in the new draft aim to align recall standards with new provisions in the Medical Device Supervision and Administration Regulation (MDSAR), issued by the State Council in 2014.
The draft highlights key points leading to a recall: the medical device poses hazardous risks, the medical device does not meet regulation standards, violations of current medical device regulations occur during manufacturing/distribution, or if any other adverse events occur. In addition, the draft provides guidelines for recall management. Within China, this includes monitoring safety, communication with the CFDA, organization of the process, and compensation and penalties. If finalized, the new rules would also increase the obligation of distributors and other entities to report defective devices. Information on recalls must subsequently be published on the CFDA database.