Izindaba

Njengamanje, ubhubhane olusha lwe-coronavirus (COVID-19) luyasakazeka. Ukusabalala komhlaba wonke kuhlola ikhono lawo wonke amazwe lokulwa nalolu bhubhane. Ngemuva kwemiphumela emihle yokuvimbela nokulawula ubhubhane eShayina, amabhizinisi amaningi asekhaya ahlose ukukhuthaza imikhiqizo yawo ukusiza amanye amazwe nezifunda ngokubambisana ukumelana nalolu bhubhane. NgoMashi 31, 2020, uMnyango Wezohwebo, Ukuphathwa Okujwayelekile Kwezentela kanye Nokuphathwa Kwezidakamizwa Kahulumeni waseShayina bakhiphe isimemezelo esihlangene ngamadivayisi ezokwelapha ahlobene nokuvimbela ubhubhane lwe-coronavirus (njengezinto zokuthola, imaski yezokwelapha, izingubo zokuzivikela zezokwelapha, ama-ventilator kanye nama-thermometer e-infrared), okuchaza ukuthi kusukela ngo-Ephreli 1, abathumeli bemikhiqizo enjalo kumele bafakazele ukuthi bathole isitifiketi sokubhalisa samadivayisi ezokwelapha eShayina Futhi bahlangabezane nezindinganiso zekhwalithi zamazwe noma izifunda ezithumela ngaphandle. Amasiko angakhulula izimpahla kuphela ngemuva kokuthi ziqinisekiswe njengezifanelekile.

Isimemezelo esihlanganyelwe sibonisa ukuthi iShayina ibheka kakhulu ikhwalithi yezinto zokwelapha ezithunyelwa kwamanye amazwe. Okulandelayo ukufingqwa kwezinye izinkinga okulula ukuzidida uma zithunyelwa kwamanye amazwe e-European Union nase-United States.

iyuniyani yase-Europe

（1） Mayelana nophawu lwe-CE

I-CE umphakathi waseYurophu. Uphawu lwe-CE luyimodeli yokulawula ye-EU yemikhiqizo ebhalwe ku-EU. Emakethe ye-EU, isitifiketi se-CE singesesitifiketi somthetho esiphoqelelwe. Kungakhathaliseki ukuthi imikhiqizo ekhiqizwa amabhizinisi ngaphakathi kwe-EU noma imikhiqizo ekhiqizwa kwamanye amazwe ifuna ukusabalala ngokukhululeka emakethe ye-EU, uphawu lwe-CE kumele lunamathiselwe ukuze kuboniswe ukuthi imikhiqizo iyahambisana nezidingo eziyisisekelo zendlela entsha yokuvumelanisa ubuchwepheshe kanye nokulinganisa. Ngokwezidingo ze-PPE kanye ne-MDD / MDR, imikhiqizo ethunyelwa e-EU kufanele ibhalwe uphawu lwe-CE.

（2） Mayelana Nezitifiketi

Ukunamathisela uphawu lwe-CE kuyisinyathelo sokugcina ngaphambi kokuba umkhiqizo ungene emakethe, okubonisa ukuthi zonke izinqubo seziqediwe. Ngokwezidingo ze-PPE kanye ne-MDD / MDR, imishini yokuzivikela yomuntu siqu (njengemaski yokuzivikela yomuntu siqu yekilasi III) noma imishini yezokwelapha (njengokuhlanza imaski yezokwelapha yekilasi I) kufanele ihlolwe yinhlangano enolwazi (NB) eqashelwa yi-European Union. Isitifiketi se-CE sedivayisi yezokwelapha kufanele sikhishwe yinhlangano enolwazi, futhi isitifiketi kufanele sibe nenombolo yomzimba onolwazi, okungukuthi, ikhodi eyingqayizivele yezinombolo ezine.

（3） Izibonelo zezimfuneko zemikhiqizo yokuvimbela ubhubhane

1. Amamaski ahlukaniswe ngamamaski ezokwelapha kanye namamaski okuzivikela.

Ngokusho kwe-en14683, imaski ihlukaniswe ngezigaba ezimbili: uhlobo I kanye nohlobo II / IIR. Imaski yohlobo I ifanelekela kuphela iziguli kanye nabanye abantu ukunciphisa ingozi yokutheleleka kanye nokudluliselwa, ikakhulukazi uma kunezifo ezithelelanayo noma ubhubhane. Imaski yohlobo II isetshenziswa kakhulu odokotela egunjini lokuhlinza noma kwenye indawo yezokwelapha enezidingo ezifanayo.

2. Izingubo zokuzivikela: izingubo zokuzivikela zihlukaniswe ngezingubo zokuzivikela zezokwelapha kanye nezingubo zokuzivikela zomuntu siqu, futhi izidingo zokuphatha kwazo zifana kakhulu nezemaski. Izinga laseYurophu lezingubo zokuzivikela zezokwelapha lingu-en14126.

(4) Izindaba zakamuva

I-EU 2017 / 745 (MDR) iwumthetho omusha wedivayisi yezokwelapha ye-EU. Njengenguqulo ethuthukisiwe ye-93 / 42 / EEC (MDD), lo mthetho uzoqala ukusebenza futhi uqaliswe ngokugcwele ngoMeyi 26, 2020. NgoMashi 25, iKhomishini yaseYurophu yamemezela isiphakamiso sokuhlehlisa ukusetshenziswa kwe-MDR ngonyaka owodwa, esathunyelwa ekuqaleni kuka-Ephreli ukuze sivunywe yiPhalamende laseYurophu kanye noMkhandlu ngaphambi kokuphela kukaMeyi. Zombili i-MDD kanye ne-MDR zichaza ukusebenza komkhiqizo ukuqinisekisa impilo nokuphepha kwabasebenzisi.