In vitro diagnostic reagent kulembetsa/bungwe lolemba
Mtundu woyamba wa in vitro diagnostic reagents uyenera kuyang'aniridwa ndi kasamalidwe kazinthu.Class II ndi Class Ill in vitro diagnostic reagents aziyang'aniridwa ndi kasamalidwe ka kalembera wazinthu.
Lowetsani mtundu woyamba wa in vitro diagnostic reagents kuti mulembe, ndipo wofayiloyo azipereka zolembera ku National Medical Products Administration.Kalasi Yachiwiri Yam'mwamba ndi Class 111 in vitro diagnostic reagents aziwunikiridwa ndi National Medical Products Administration, ndipo pambuyo pa chivomerezo, satifiketi yolembetsa chipangizo chachipatala idzaperekedwa.

Centralized management department
National Medical Products Administration imayang'anira kalembera ndi kasamalidwe ka ma in vitro diagnostic reagents m'dziko lonselo, imakonza zowunikira ndi kuvomereza mitundu yachiwiri ndi yachitatu ya in vitro diagnostic reagents, ndikulemba mbiri ndi kuyang'anira ndi kuyang'anira mitundu yoyamba ya in. vitro diagnostic reagents malinga ndi lamulo;
National Medical Products Administration Medical Device Technical Evaluation Center ndiyomwe imayang'anira ntchito yowunikira ntchito yolembetsa, kusintha kalembera, kukonzanso kalembera, ndi zina za Class Ill ku China komanso zotengera Class II ndi Class Ill in vitro diagnostic reagents.

Gulu loyang'anira la "Administrative Measures"
Munthawi yolosera za matenda, kupewa, kuzindikira, kuyang'anira chithandizo, kuwunika kwanthawi yayitali komanso kuwunika kwaumoyo, ma reagents, zida, ma calibrator, zinthu zowongolera bwino ndi zinthu zina zomwe zimagwiritsidwa ntchito pozindikira zitsanzo za anthu mu m'galasi zitha kugwiritsidwa ntchito zokha kapena kuphatikiza zida. , zida, zida kapena machitidwe.Zowunikira mu vitro zowunikira gwero la magazi ndi zowunikira mu m'galasi zolembedwa ndi ma radionuclides sizili m'gulu la njira zoyendetsera.