Following a significant revision of its framework medical device regulation (see our alert, here),
the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), which is the primary regulation for medical device adverse events. The proposed Measures contain the requirements for reporting, evaluating, and remediating adverse events and serious adverse events for both imported and domestically manufactured devices in China. The comment period closed on December 20th. We describe some of the key points of the proposed Measures below.
The proposed Measures are a revision of a 2008 rule of the same name. The proposed Measures contain a number of changes to the medical device adverse event reporting system, including
- the addition of a new definition of serious adverse event (SAE),
- a system of enhanced monitoring for certain devices,
- a set of detailed requirements and timelines for government agencies, manufacturers, distributors, and healthcare institutions to monitor, report on, and analyze adverse events.
To read the article by John Balzano