Jul 24, 2018
EMERGO SUMMARY OF KEY POINTS:
The China Food and Drug Administration (CFDA) has drafted a new batch of medium- and high-risk medical devices and IVDs slated for exemption from clinical trial requirements in the country.
CFDA’s latest draft publication (link in Chinese) includes a fourth batch of Class II and III medical devices such as arteriovenous lancets, aneurysm clips, anesthesia needles and incubators; the draft also includes a third batch of Class II IVDs, as well as the first batch of Class III IVDs to potentially be exempt from clinical trials.
In addition, CFDA has issued a draft compilation catalogue covering the first three batches of Class II and III device exemption lists that incorporate revisions laid out in the regulator’s new classification catalogue published in late 2017.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: