Adjusted Classification System Requires Re-Registration of Medical Devices in China

Since 2000, China’s State Food and Drug Administration (SFDA) classified registered medical devices into Classes I, II, and III according to the intended use of the medical device and the risks associated with its use. The SFDA recently adjusted their medical device classification criteria and will require all affected parties to re-register their medical devices as outlined in its public notice regarding these changes (SFDA 2012, No. 70).

For medical devices that were downgraded after the classification adjustment (i.e. medical devices that were originally classified at a high level), no immediate registration certificate changes will be necessary. The existing registration license will remain valid until expiry, after which the medical device manufacturer will need to re-register the medical device under its new, lower classification grade.

For medical devices that are now subject to a higher-class grade than which it was originally registered, the medical device manufacturer will be required to re-register within six months with the appropriate, higher-level classification.  The existing registration certificate will remain valid until the new license is approved. This new public notice (2012) follows Article 35 of SFDA’s Order 16 Measures for the Administration of Medical Devices Registration.