Newsletter

Notice on Implementation of Provisions for Medical Device Registration and Registration of In-Vitro Diagnostic Reagents by China Food and Drug Administration SYJXG [2015] No. 247

Updated: 2017/9/8

To the food and drug administrations of provinces, autonomous regions and municipalities directly under the central government:

The newly revised Provisions for Medical Device Registration (CFDA Order No. 4) and Provisions for Registration of In-Vitro Diagnostic Reagents (CFDA Order No. 5) have been implemented as of October 1, 2014. To further improve the transition of the rules and regulations, the relevant issues are hereby notified as follows:

I.     Issues concerning the review of product registration application accepted prior to the implementation of new mandatory standards

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