Details on China’s New Regulation for IVDs

In late 2014, the China Food and Drug Administration (CFDA)’s Order No. 5 regarding administrative measures for the registration of in vitro diagnostic (IVD) reagents went into effect.

The new administrative measures brought about several changes to the regulation of IVDs. For example, certificate validation now lasts for 5 years rather than 4 years. In addition, country of origin requirements have been eased to accept approval in the country of the manufacturing site in addition to approval in the country of the legal manufacturer.

Several efforts were made to simplify and speed up the registration process. Class I IVDs only require filing; registration is no longer required. If an applicant is uncertain of whether a product should be registered as a Class II or Class III IVD product, they are now given the option to register right away under the highest Class III classification rather than applying and waiting for a classification approval first. Special registration for innovative IVDs has also been opened to allow an expedited pathway for innovative IVD products.

However, additional documents are now required, including the Risk Analysis Report. The Product Registration Standard is no longer requested, but technical documents regarding the raw materials and production process have to be submitted in its place.

Under the previous regulation, type testing and local clinical trials could be conducted simultaneously, but now under the new regulation, type testing must be completed first prior to starting clinical trials. Also, the time limit for submitting supplementary materials has been extended to 1 year from the previous 120 days.

There are now two separate re-registration pathways, consisting of extension registrations and re-registrations with change. Previously, all products — even products with changes — could make one single submission, combining the registration for an extension along with the change registration. Now, all products with any major changes must apply for the re-registration with change review. Only products without any major changes may apply for the simpler extension process.

The CFDA no longer needs to be notified of a change from a higher classification to a lower classification, although a registration change is still required immediately if the classification is changed from lower to higher.