Iindaba

Okwangoku, ubhubhane omtsha we-coronavirus (COVID-19) usasazeka. Ukusasazeka kwehlabathi kuvavanya amandla elizwe ngalinye okulwa nobhubhane. Emva kweziphumo ezilungileyo zokuthintela nokulawula ubhubhane eTshayina, amashishini amaninzi asekhaya aceba ukuthengisa iimveliso zawo ukunceda amanye amazwe kunye nemimandla ukuba ixhathise ubhubhane ngokudibeneyo. Ngomhla wama-31 kuMatshi 2020, uMphathiswa wezoRhwebo, uLawulo oluPhezulu lwezeMithetho kunye noLawulo lweMithi yeSizwe yaseTshayina bakhuphe isibhengezo esidibeneyo malunga nezixhobo zonyango ezinxulumene nokuthintela ubhubhane we-coronavirus (ezifana nezixhobo zokufumanisa, iimaski zonyango, impahla yokukhusela yezonyango, ii-ventilators kunye ne-infrared thermometers), nto leyo echaza ukuba ukususela nge-1 ka-Epreli, abathumeli ngaphandle ezo mveliso kufuneka babonakalise ukuba bafumene isatifikethi sobhaliso lwezixhobo zonyango eTshayina Kwaye bahlangabezane nemigangatho yomgangatho yamazwe okanye imimandla ethumela ngaphandle. I-custom inokukhulula iimpahla kuphela emva kokuba ziqinisekisiwe njengezifanelekileyo.

Isibhengezo esidibeneyo sibonisa ukuba iTshayina iwubona ubaluleke kakhulu umgangatho wezixhobo zonyango ezithunyelwa kwamanye amazwe. Oku kulandelayo sisishwankathelo seengxaki ezilula ukudideka xa zithunyelwa kwiManyano yaseYurophu nase-United States.

udibano lwaseyurophu

（1） Malunga nophawu lwe-CE

I-CE luluntu lwaseYurophu. Uphawu lwe-CE luyimodeli yolawulo ye-EU yeemveliso ezidweliswe kwi-EU. Kwimarike ye-EU, isatifikethi se-CE sisesesiqinisekiso somthetho esinyanzelekileyo. Nokuba iimveliso eziveliswe ngamashishini ngaphakathi kwe-EU okanye iimveliso eziveliswe kwamanye amazwe zifuna ukujikeleza ngokukhululekileyo kwimarike ye-EU, uphawu lwe-CE kufuneka luncamathiselwe ukubonisa ukuba iimveliso ziyahambelana neemfuno ezisisiseko zendlela entsha yokuvumelanisa ubuchwepheshe kunye nokulinganisa. Ngokweemfuno ze-PPE kunye ne-MDD / MDR, iimveliso ezithunyelwa kwi-EU kufuneka ziphawulwe ngophawu lwe-CE.

（2） Malunga neeSatifikethi

Ukuncamathisela uphawu lwe-CE linyathelo lokugqibela ngaphambi kokuba imveliso ingene kwimarike, nto leyo ebonisa ukuba zonke iinkqubo zigqityiwe. Ngokweemfuno ze-PPE kunye ne-MDD / MDR, izixhobo zokuzikhusela zobuqu (ezifana nemaski yokuzikhusela yodidi lwesithathu) okanye izixhobo zonyango (ezifana nokucoca imaski yonyango yodidi lokuqala) kufuneka zihlolwe yiqumrhu elinolwazi (NB) elivunyiweyo yi-European Union. Isatifikethi se-CE sesixhobo sonyango kufuneka sikhutshwe yiqumrhu elinolwazi, kwaye isatifikethi kufuneka sibe nenombolo yequmrhu elinolwazi, oko kukuthi, ikhowudi eneenombolo ezine ezikhethekileyo.

（3） Imizekelo yeemfuno zeemveliso zokuthintela ubhubhane

1. Iimaski zahlulwe zibe ziimaski zonyango kunye neemaski zokuzikhusela zomntu.

Ngokwe-en14683, iimaski zahlulwe zibe ziindidi ezimbini: uhlobo I kunye nohlobo II / IIR. Imaski yohlobo I ifanelekela kuphela izigulana kunye nabanye abantu ukunciphisa umngcipheko wokosuleleka kunye nokudluliselwa, ingakumbi kwimeko yezifo ezosulelayo okanye ubhubhane. Imaski yohlobo II isetyenziswa kakhulu ziingcali zonyango kwigumbi lotyando okanye kwenye indawo yezonyango eneemfuno ezifanayo.

2. Impahla yokukhusela: impahla yokukhusela yahlulwe yaba yimpahla yokukhusela yezonyango kunye nempahla yokukhusela yomntu, kwaye iimfuno zayo zolawulo ziyafana nezo zeemaski. Umgangatho waseYurophu wempahla yokukhusela yezonyango yi-en14126.

(4) Iindaba zamva nje

I-EU 2017/745 (MDR) ngumgaqo omtsha wezixhobo zonyango ze-EU. Njengenguqulelo ephuculweyo ye-93/42 / EEC (MDD), lo mgaqo uza kuqala ukusebenza kwaye uqaliswe ngokupheleleyo ngoMeyi 26, 2020. Ngomhla wama-25 kuMatshi, iKhomishini yaseYurophu yabhengeza isindululo sokuhlehlisa ukuphunyezwa kwe-MDR ngonyaka omnye, esangeniswa ekuqaleni kuka-Epreli ukuze sivunywe yiPalamente yaseYurophu kunye neBhunga ngaphambi kokuphela kukaMeyi. Zombini i-MDD kunye ne-MDR zichaza ukusebenza kwemveliso ukuqinisekisa impilo nokhuseleko lwabasebenzisi.