Jul 24, 2018

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have added additional Class II and III medical devices as well as some Class III IVD devices to their list of products exempted from clinical trial requirements.
  • Devices in the latest batch of exemptions include lancets, anesthesia needles and incubators.

China FDA adds to medical device and IVD clinical trial exemption list 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.

More Chinese medical device regulatory resources:

  • China CFDA medical device registration and approval consulting
  • CFDA clinical and testing requirements assessment