China FDA Proposes Revisions to Medical Device Adverse Event Regulations

In December 2015, the China Food and Drug Administration (CFDA) proposed a number of revisions that would modify existing rules regarding medical device adverse event reporting. While the rules have yet to be implemented, the proposals represent significant changes to existing laws. The proposed changes include:

  • Dividing all adverse events into two categories. One category containing all “normal” adverse events and another category containing serious adverse events (SAEs).
  • SAEs are classified as events that cause death or permanent damage to the human body, endanger human life, or cause circumstances that lead to an injury or death.
  • Healthcare providers or device manufacturers must report a SAE within 15 days of its occurrence. If the SAE results in death, it must be reported within 5 days. Normal adverse events must be reported within 30 days.
  • Chinese manufacturers and foreign device companies that manufacture within China must also report SAEs that occur abroad. They have 15 days to report such events.
  • Devices that frequently cause adverse events will be monitored more closely by China’s regulatory authorities.