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Iindaba

Okwangoku, iNovel Coronavirus (Covid-19) Ubhubhane uyasasazeka. Ukusasazeka kwehlabathi kuvavanya amandla alo lonke ilizwe ukulwa nobhubhane. Emva kweziphumo ezilungileyo zothintelo kunye nolawulo e-China, uninzi lwamashishini anomdla wokukhuthaza iimveliso zawo ukunceda amanye amazwe kunye nemimandla nje ixhathise ubhubhane. Ngo-Matshi 31, 2020, iSebe lezoRhwebo, uLawulo lweSiko Jikelele kunye noLawulo lweSiyobisi kwi-China wakhupha isibhengezo sezonyango esinxulumene nesixhobo sobhaliso kwizixhobo zonyango e-China kwaye sihlangabezana nemigangatho esemgangathweni ye Ukuthumela ilizwe okanye imimandla. Izithethe zinokukhulula iimpahla kuphela emva kokuba ziqinisekisiwe.

Isibhengezo esidibeneyo sibonisa ukuba i-china ibaluleke kakhulu kumgangatho wezinto zonyango ezithunyelwa ngaphandle. Oku kulandelayo sisishwankathelo sezinye iingxaki ekulula ukudideka xa ikhutshelwe ngaphandle i-European Union naseMelika.

udibano lwaseyurophu

(1) Malunga ne-CE SMA

I-CE ngabahlali baseYurophu. Imodeli ye-CE yimodeli yolawulo ka-EU yeemveliso ezidweliswe kwi-EU. Kwimarike ye-EU, iKrestices yeyokuqinisekiswa kommiselo onyanzelekileyo. Nokuba iimveliso ezenziwa ngamashishini ngaphakathi kwe-EU okanye iimveliso eziveliswe kwamanye amazwe zifuna ukujikeleza ngokukhululekileyo kwimarike ye-EU, iMakis kufuneka ichaphazeleke ukubonisa ukuba iimveliso zihambelana neemfuno ezisisiseko zendlela ehambelana nobugcisa kunye nokubekwa emgangathweni. Ngokweemfuno ze-PPE kunye ne-MDD / MDR, iimveliso ezithunyelwa ngaphandle kwi-EU kufuneka ifakwe i-COMark.

(2) Malunga nezatifikethi

Ukudlula kumanqaku e-CE linyathelo lokugqibela ngaphambi kokuba imveliso ingena kwimarike, ibonisa ukuba zonke iinkqubo zigqityiwe. Ngokweemfuno ze-PPE kunye ne-MDD / MDR, izixhobo zokukhusela (ezinjengeeklasi ze-III) okanye izixhobo zonyango (i-NB) ezamkelwe yi-European Union. Isatifikethi se-Ce sezonyango kufuneka sikhutshwe ngumzimba oqinisekisiweyo, kwaye isatifikethi kufuneka sibe nenani lomzimba oqinisekisiweyo, oko kukuthi, ikhowudi yamanani amane.

(3) Imizekelo yeemfuno zemveliso yokuthintela i-pile

I-1. Iimaski zahlulwe zaba zemaski zonyango kunye neemaski zakho ezikhuselayo.

 

Ngokuka-En14683, iimaski zahlulwe zangamacandelo amabini: Chwetheza mna kunye nohlobo lwe-II / irier. Chwetheza imaski ilungele izigulana kunye nabanye abantu ukuba banciphise umngcipheko wokosuleleka kunye nosulelo, ngakumbi kwimeko yezifo ezosulelayo okanye i-etidemics. Chwetheza ii-II IIK isetyenziswa ikakhulu ngabaSebenzisi begumbi lokusebenza okanye kwenye indawo yezonyango ezineemfuno ezifanayo.

2. Impahla ekhuselayo: Impahla ekhuselayo yahlulahlulwa yangena kwimpahla yokhuselo kwezonyango kunye nempahla yokhuselo, kwaye iimfuno zayo zolawulo ziyafana nezo zemaski. UMGAQO-NKQUBO WE-EUROPE YEMALI YOLUNGU SOKUKHANYA I-En14126.

(4) Iindaba zamva nje

I-EU ngo-2017/745 (MDR) ngummiselo wesixhobo esitsha se-EU. Njengombhalo ophuculweyo we-93/42 / i-EEC (MD), ummiselo uya kusebenza kwaye umiliselwe ngokupheleleyo ngoMeyi 26, iKhomishini yaseYurophu yazisa ekuqaleni kwePalamente yaseYurophu kunye neBhunga ngaphambi kokuphela kukaMeyi. Zombini i-MDR kunye ne-MDR ichaza intsebenzo yemveliso yokuqinisekisa impilo kunye nokhuseleko lwabasebenzisi.


IXESHA LOKUQALA: UJan-18-2021