Chang-Hong Whitney10.21.06
China’s State Food And Drug Administration (SFDA) has been working to strengthen the inspection and surveillance policies on products approved to market in China. The SFDA drafted a regulation in April 2002 on its postmarket surveillance program and conducted a trial inspection on some Class III products, such as cardiac stent catheters and heart valves in 2003.
With the positive feedback from this trial program, in January 2004 the SFDA published a draft version of Medical Device Adverse Incident Supervision Management Method, which specified the reporting mechanism and time requirements for adverse incident reporting and corrective actions as well as provided framework on product re-evaluations.
This policy designated China’s Drug Adverse Incident Reporting Center (CDR) as the top-level agency responsible for data collection, incident evaluation, training and other administrative functions. Each province set up its own adverse incident reporting center to respond to incidents within its own jurisdiction. This policy also gave the CDR and provincial centers the authority to determine punitive measures for companies that fail to report adverse events.
The reporting chain begins from the provincial center, which collects reports on “suspicious” adverse incidents that organizations (manufacturers, distribution companies and hospitals) submit each month. Reports on incidents that caused serious patient injury are required to be submitted within 10 business days after the occurrences. Incidents that caused death must be reported to the provincial center and CDR within 24 hours. The manufacturer of the product involved also is required to submit a follow-up report within 20 business days to provide additional product information, user manuals, an incident follow-up investigation report, patient information and possible causes of the incident. Corrective actions and information on other similar products produced by the manufacturer also should be included in the follow-up report.