The Drug Administration adjusts part of the Sub-Catalog of 6840 In-body Diagnostic Reagents Classification (2013 Edition).

First, the adjustment content of the "6840 in-body diagnostic reagent classification sub-catalog" product category III-7 and tumor marker-related reagents part of the in-body diagnostic reagent management category and expected use of adjustment, the specific adjustment content is attached.
II. Implementation requirements (1) From the date of this announcement, the drug regulatory department shall, in accordance with the Measures for the Administration of the Registration of In-body Diagnostic Reagents, the Amendments to the Measures for the Registration and Administration of In-body Diagnostic Reagents, and the Announcement on the Publication of the Information requirements for the Registration and Declaration of In-body Diagnostic Reagents and the Approval of the Form of The Supporting Documents, accept the registration of in-body diagnostic reagents in accordance with the adjusted categories for review and approval.
(2) For in-body diagnostic reagents that have not yet been approved for registration, the drug regulatory department shall continue to approve the registration in accordance with the original acceptance category, issue the medical device registration certificate, and indicate the adjusted product management category in the registration certificate comments column.
(iii) For registered in-body diagnostic reagents whose management category is adjusted from high to low, the medical device registration certificate shall remain in effect for the duration of the validity period.
If renewal is required, the registrar shall, six months before the expiration of the validity period of the medical device registration certificate, apply to the corresponding drug regulatory department for renewal of registration in accordance with the changed category, and grant the renewal of the registration, issue the medical device registration certificate in accordance with the adjusted product management category.
change of registration occurs within the validity period of the medical device registration certificate, the registrar shall apply to the original registration department for a change of registration.
(5) Provincial drug supervision and administration departments should strengthen the "6840 in vitro diagnostic reagent classification sub-catalogue (2013 edition)" category adjustment of the public training, and effectively do a good job in the relevant product review and approval and post-market supervision.
this announcement shall be implemented from the date of publication.
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