Feb 15, 2017


  • The China FDA has modified its classification requirements for IVD devices with immediate effect.
  • The rule changes are intended to provide more maneuverability to the CFDA in terms of overseeing IVD safety in China.

Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk levels.

CFDA Order No. 30 (link in Chinese) modifies the regulator’s Order No. 5 on IVD registration with immediate effect. The order states that IVD classification rules will be used as guidance for developing and adjusting the CFDA’s IVD classification catalog, and for determining whether to create new IVD device categories.

Furthermore, Order No. 30 establishes that the CFDA has the authority to adjust classification rules for an IVD depending on changes to the device’s risk levels.

Key takeaway: Due to rapid development of IVD technologies and widespread application of these products in Chinese healthcare settings, the CFDA’s existing classification rules may not have accuratley reflected actual risk levels posed by some IVD devices. Through this modification, Chinese regulators have more leewayt to adjust IVD classification rules based on industry changes.


  • Stewart Eisenhart