News

Circular of the State Food and Drug Administration on Issuing 7 guiding principles for registration technology review, including the guiding principles for registration technology review of household

2021-02-02 11:27:35 vcc 14

In order to strengthen the supervision and guidance of the registration of medical devices, and further improve the quality of the registration examination, the State Drug Administration has formulated the guiding principles for the technical examination of the registration of household in vitro diagnostic medical devices, the guiding principles for the technical examination of the registration of specific protein immune analyzer, the guiding principles for the technical examination of the registration of prolactin detection reagents, and the guiding principles for the technical examination of total triiodothyronine The guidelines for the technical review of the registration of amino acid test reagents, the guidelines for the technical review of the registration of 25 hydroxyvitamin D test reagents, the guidelines for the technical review of the registration of serum amyloid a test reagents and the guidelines for the technical review of the registration of rheumatoid factor test reagents are hereby released.

Notice is hereby given.

Annex: 1. Guiding principles for technical examination of household in vitro diagnostic medical device registration

            2. Guidelines for technical review of registration of specific protein immunoassay analyzer

            3. Guidelines for technical review of prolactin test reagent registration

            4. Guidelines for technical review of total triiodothyronine test reagent registration

            5.Guidelines for technical review of 5.25-hydroxyvitamin D test reagent registration

            6. Guidelines for technical review of serum amyloid a test reagent registration

            7. Guidelines for technical review of rheumatoid factor test reagent registration

                                                                                                                                                     State Food and Drug Administration

                                                                                                                                                                                       December 1, 2020

Annex 1.doc of circular No.80 of State Drug Administration in 2020

Annex 2.doc of circular No.80 of State Drug Administration in 2020

Annex 3.doc of circular No.80 of State Drug Administration in 2020

Annex 4.doc of circular No.80 of State Drug Administration in 2020

Annex 5.doc of circular No.80 of State Drug Administration in 2020

Annex 6.doc of circular No.80 of State Drug Administration in 2020

Annex 7.doc of circular No.80 of State Drug Administration in 2020