Iindaba

Okwangoku, ubhubhani we-coronavirus (COVID-19) uyasasazeka.Ukusasazeka kwehlabathi kuvavanya amandla elizwe ngalinye ukulwa lo bhubhani.Emva kweziphumo ezilungileyo zothintelo kunye nolawulo lwendyikityha e-China, amashishini amaninzi asekhaya anenjongo yokukhuthaza iimveliso zawo ukunceda amanye amazwe kunye nemimandla ngokudibeneyo ukumelana nobhubhane.Ngomhla wama-31 kuMatshi ka-2020, i-Ofisi yoMphathiswa wezoRhwebo, i-General Administration of thecus and the State Drug Administration yase-China yakhupha isaziso esidityanelweyo kwizixhobo zonyango ezinxulumene nothintelo lwe-coronavirus (ezifana nezixhobo zokubona, iimaski zonyango, iimpahla ezikhuselayo zonyango, ii-ventilators kunye nezixhobo zokuphefumla kunye nezixhobo zonyango. I-thermometers ye-infrared), echaza ukuba ukususela ngo-Aprili 1, abathumeli beemveliso ezinjalo kufuneka babonise ukuba bafumene isatifikethi sokubhaliswa kwezixhobo zonyango e-China kwaye bahlangabezane nemigangatho yomgangatho wamazwe athumelayo okanye imimandla.Amasiko anokukhulula iimpahla kuphela emva kokuba ziqinisekisiwe ukuba zifanelekile.

Isibhengezo esidibeneyo sibonisa ukuba i-China ibona ukubaluleka okukhulu kumgangatho wezinto zonyango ezithunyelwa ngaphandle.Oku kulandelayo sisishwankathelo sezinye iingxaki ekulula ukubhidaniswa xa zithunyelwa kumazwe e-European Union nase-United States.

udibano lwaseyurophu

(1) Malunga nophawu CE

CE luluntu lwaseYurophu.Uphawu lwe-CE yimodeli yolawulo ye-EU kwiimveliso ezidweliswe kwi-EU.Kwimarike ye-EU, isatifikethi se-CE sesesatifikethi esisisinyanzelo sommiselo.Nokuba iimveliso eziveliswe ngamashishini angaphakathi kwe-EU okanye iimveliso eziveliswe kwamanye amazwe zifuna ukujikeleza ngokukhululekileyo kwimarike ye-EU, uphawu lwe-CE kufuneka luncanyatheliswe ukubonisa ukuba iimveliso zithobelana neemfuno ezisisiseko zendlela entsha yokudityaniswa kobugcisa kunye nomgangatho.Ngokweemfuno zePPE kunye neMDD / MDR, iimveliso ezithunyelwa ngaphandle kwe-EU kufuneka zibhalwe ngophawu lweCE.

(2) Malunga neZatifikethi

Ukuncamathisela uphawu lweCE linyathelo lokugqibela phambi kokuba imveliso ingene emarikeni, nto leyo ebonisa ukuba zonke iinkqubo zigqityiwe.Ngokweemfuno zePPE kunye ne-MDD / MDR, izixhobo zokukhusela zomntu (ezifana neklasi ye-III yokukhusela i-mask) okanye izixhobo zonyango (ezifana nodidi lokuqala lwe-mask sterilization) kufuneka zihlolwe ngumbutho owazisiweyo (NB) ovunyiweyo yi-European Union. .Isatifikethi seCE sesixhobo sonyango kufuneka sikhutshwe ngumzimba owazisiweyo, kwaye isatifikethi kufuneka sibe nenombolo yebhodi eyazisiweyo, oko kukuthi, ikhowudi enamanani amane awodwa.

(3) Imizekelo yeemfuno zeemveliso zokuthintela ubhubhane

1. Iimaski zohlulwe zibe ziimaski zonyango kunye neemaski zokuzikhusela.

Ngokutsho kwe-en14683, iimaski zohlulwe zibe ngamacandelo amabini: uhlobo I kunye nohlobo II / IIR.Imaski yohlobo lwe-I ilungele kuphela izigulane kunye nabanye abantu ukunciphisa umngcipheko wokosuleleka kunye nosulelo, ngakumbi kwimeko yezifo ezosulelayo okanye ubhubhane.Imaski yohlobo lwe-II isetyenziswa ikakhulu ngabasebenzi bezonyango kwigumbi lokusebenza okanye kwenye indawo yezonyango eneemfuno ezifanayo.

2. Impahla ekhuselayo: Impahla ekhuselayo yahlulwe yaba yimpahla yokhuselo lwezonyango kunye nempahla yokuzikhusela, kwaye iimfuno zayo zolawulo ziyafana nezeemaski.Umgangatho waseYurophu wempahla yokukhusela yonyango yi-en14126.

(4) Iindaba zamva nje

I-EU 2017 / 745 (MDR) ngummiselo omtsha we-EU wesixhobo sonyango.Njengenguqu ephuculweyo ye-93 / 42 / EEC (MDD), ummiselo uya kuqala ukusebenza kwaye uphunyezwe ngokupheleleyo ngoMeyi 26, 2020. Ngo-Matshi 25, iKhomishini yaseYurophu ibhengeze isiphakamiso sokuhlehlisa ukuphunyezwa kwe-MDR ngonyaka omnye. eyangeniswa ekuqaleni kuka-Epreli ukuze ivunywe yiPalamente yaseYurophu kunye neBhunga ngaphambi kokuphela kukaMeyi.Zombini i-MDD kunye ne-MDR zicacisa ukusebenza kwemveliso ukuqinisekisa impilo kunye nokhuseleko lwabasebenzisi.