The State Food and Drug Administration issued 14 guidelines for registration review including fluorescence immunochromatography analyzers

On December 28, the State Food and Drug Administration issued an announcement stating that in order to strengthen the supervision and guidance of the registration of medical device products and further improve the quality of registration review, in accordance with the "Administrative Measures for Medical Device Registration and Filing" (Order No.
47) and the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order No.
48 of the State Administration for Market Regulation), the State Drug Administration organized and formulated 14 guiding principles for registration and review of fluorescence immunochromatography analyzers (see attachments).
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Now published
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The details are as follows: 1.
Guidelines for the registration and review of fluorescence immunochromatography analyzers 2.
Guidelines for the registration and review of mesh nebulizers 3.
Guidelines for the registration and review of medical diagnostic X-ray equipment with pediatric applications 4.
Ultrasound transcranial Doppler blood Guidelines for the registration and review of flow analyzers 5.
Guidelines for registration and review of hydrogen peroxide sterilizers 6.
Guidelines for registration and review of neonatal blue light therapy devices 7.
Guidelines for registration and review of root canal preparation machines 8.
Guidelines for registration and review of blood cell analyzers9 .
Guidelines for the registration review of gait training equipment Principle 12.
Guidelines for Registration Review of Retinol Binding Protein Assay Kit (Immunoturbidimetric Method) 13.
Guidelines for Registration Review of Folic Acid Assay Reagent 14.
Guidelines for Registration Review of Anti-Mullerian Hormone Assay Reagent