Txij li thaum lub ntsej muag kho mob tau sau npe lossis tswj raws li cov cuab yeej kho mob hauv ntau lub tebchaws lossis cheeb tsam, cov neeg siv khoom tuaj yeem paub qhov txawv ntawm lawv los ntawm cov ntaub ntawv sau npe thiab kev tswj xyuas.Hauv qab no yog ib qho piv txwv ntawm Tuam Tshoj, Tebchaws Asmeskas thiab Europe.
Tuam Tshoj
Cov qhov ncauj qhov ntswg kho mob yog nyob rau hauv chav kawm thib ob ntawm cov cuab yeej kho mob hauv Suav teb, uas tau sau npe thiab tswj hwm los ntawm lub xeev cov cai tswj hwm tshuaj, thiab tuaj yeem nug los ntawm cov cuab yeej siv kho mob kom nug cov cuab yeej siv kho mob.Qhov txuas yog:
http://www.nmpa.gov.cn/WS04/CL2590/.
Tebchaws Meskas
Cov khoom siv npog ntsej muag uas tau pom zoo los ntawm US FDA tuaj yeem nug los ntawm nws lub vev xaib official los kuaj xyuas daim ntawv pov thawj tus lej, qhov txuas yog:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Tsis tas li ntawd, raws li txoj cai tshiab ntawm FDA, tam sim no tau lees paub tias yog Daim npog ntsej muag ntawm Suav Cov Qauv raws li qee qhov xwm txheej, thiab qhov txuas ntawm nws cov chaw lag luam tso cai yog:
https://www.fda.gov/media/136663/download.
European Union
Kev xa tawm ntawm EU lub qhov ncauj qhov ntswg kho mob tuaj yeem ua tau los ntawm kev tso cai Cov Ntawv Ceeb Toom, ntawm qhov Kev Ceeb Toom Lub Cev tau tso cai los ntawm EU Medical Device Directive 93/42 / EEC (MDD) yog:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13.
Daim ntawv ceeb toom lub cev nug qhov chaw nyob tau tso cai los ntawm EU Kev Tswj Xyuas Khoom Siv Kho Mob EU 2017/745 (MDR) yog:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.
Post lub sij hawm: Apr-17-2022