Amendment to Provisions for In Vitro Diagnostic Reagent Registration (Decree No. 30 of China Food and Drug Administration)

Issued on February 8, 2017

Decree of China Food and Drug Administration

No.30

The Amendment to Provisions for In Vitro Diagnostic Reagent Registration adopted at the executive meeting of China Food and Drug Administration on January 5, 2017, is hereby promulgated and shall be effective as of the date of promulgation.

Minister: Bi Jingquan

January 25, 2017

Amendment to Provisions for In Vitro Diagnostic Reagent Registration

Paragraph 1 under Article 20 is amended as: "The classification rules of invitro diagnostic reagents as described in Articles 17, 18 and 19 of these Provisions shall be used to guide the compilation and adjustment of the classification catalogue of invitro diagnostic reagents and to determine the classification of new invitro diagnostic reagents. CFDA may adjust the classification rules in accordance with any change in the risks of invitro diagnostic reagents.”

This amendment shall be effective as of the date of promulgation.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.