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On October 21, the State Drug Administration issued a notice on the adjustment of the sub-catalogue of 6840 in-body diagnostic reagents (2013 edition) (No. 112 of 2020).
. The contents of the adjustment are adjusted to the management category and intended use of some in-body diagnostic reagents in the Product Category III-7 reagents related to tumor markers in the Sub-Catalog of 6840 In-body Diagnostic Reagents, as detailed in the annex.
II. Implementation requirements (1) From the date of the issuance 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 Requirements for the Publication of the Registration and Declaration of In-body Diagnostic Reagents and the Approval of the Document Format, 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 medical device 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, if the 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 apply to the corresponding drug regulatory department for renewal of registration in accordance with the changed category six months before the expiration of the validity period of the medical device registration certificate, and if the renewal registration is granted, the medical device registration certificate shall be issued 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 in registration.
(5) The provincial drug supervision and administration departments shall strengthen the publicity training for the adjustment of the category adjustment of the sub-catalogue of 6840 in vitro diagnostic reagents (2013 edition) and effectively do a good job in the review and approval of relevant products and post-market supervision.
this announcement shall be implemented from the date of publication.
: 6840 in-body diagnostic reagent classification sub-catalog part of the adjustment table source: State Drug Administration