Amakuru

Muri iki gihe, icyorezo gishya cya coronavirus (COVID-19) kirimo gukwirakwira. Ikwirakwira ku isi yose ririmo kugerageza ubushobozi bwa buri gihugu mu kurwanya icyorezo. Nyuma y'umusaruro mwiza wo gukumira no kurwanya icyorezo mu Bushinwa, ibigo byinshi byo mu gihugu bigamije kwamamaza ibicuruzwa byabyo kugira ngo bifashe ibindi bihugu n'uturere kurwanya icyorezo hamwe. Ku ya 31 Werurwe 2020, Minisiteri y'Ubucuruzi, Ubuyobozi Bukuru bwa Gasutamo n'Ikigo cya Leta gishinzwe imiti mu Bushinwa basohoye itangazo rihuriweho ku bikoresho by'ubuvuzi bijyanye no gukumira icyorezo cya coronavirus (nk'ibikoresho byo gutahura, udupfukamunwa two kwa muganga, imyenda yo kwirinda indwara, imashini zihumeka n'ibipimo bya infrared), bivuga ko guhera ku ya 1 Mata, abohereza ibicuruzwa nk'ibyo mu mahanga bagomba kwerekana ko babonye icyemezo cyo kwiyandikisha cy'ibikoresho by'ubuvuzi mu Bushinwa kandi bujuje ibisabwa mu bihugu cyangwa uturere byohereza ibicuruzwa. Gasutamo ishobora kurekura ibicuruzwa gusa nyuma yo kwemezwa ko byujuje ibisabwa.

Itangazo ryatanzwe ku bufatanye rigaragaza ko Ubushinwa buha agaciro gakomeye ubuziranenge bw'ibikoresho by'ubuvuzi byoherezwa mu mahanga. Ibi bikurikira ni incamake y'ibibazo bimwe na bimwe byoroshye kwitiranya iyo byoherejwe mu Muryango w'Ubumwe bw'u Burayi na Leta Zunze Ubumwe za Amerika.

umuryango w'ibihugu by'i Burayi

（1） Ku bijyanye n'ikimenyetso cya CE

CE ni umuryango w’i Burayi. Ikimenyetso cya CE ni icyitegererezo cy’amategeko agenga ibicuruzwa biri mu muryango w’ubumwe bw’ibihugu by’Uburayi. Ku isoko ry’ubumwe bw’ibihugu by’Uburayi, icyemezo cya CE ni icyemezo cy’amategeko agenga ibicuruzwa. Byaba ibicuruzwa bikorerwa mu muryango w’ubumwe bw’ibihugu by’Uburayi cyangwa ibicuruzwa bikorerwa mu bindi bihugu bishaka kuzenguruka mu buryo bw’ubwisanzure ku isoko ry’ubumwe bw’ibihugu by’Uburayi, ikimenyetso cya CE kigomba gushyirwaho kugira ngo kigaragaze ko ibicuruzwa byujuje ibisabwa by’ibanze by’uburyo bushya bwo guhuza tekiniki no gushyiraho ibipimo. Dukurikije ibisabwa na PPE na MDD / MDR, ibicuruzwa byoherejwe muri EU bigomba kuba byanditseho ikimenyetso cya CE.

（2） Ku bijyanye n'Impamyabumenyi

Gushyiraho ikimenyetso cya CE ni intambwe ya nyuma mbere yuko ibicuruzwa byinjira ku isoko, bigaragaza ko ibikorwa byose byarangiye. Dukurikije ibisabwa na PPE na MDD / MDR, ibikoresho byo kwirinda umuntu ku giti cye (nk'agapfukamunwa k'umubiri ko mu rwego rwa gatatu) cyangwa ibikoresho byo kwa muganga (nk'uburyo bwo koza udupfukamunwa two kwa muganga two mu rwego rwa mbere) bigomba gusuzumwa n'ikigo cyabimenyesheje (NB) cyemewe n'Umuryango w'Ubumwe bw'u Burayi. Icyemezo cya CE cy'ibikoresho byo kwa muganga kigomba gutangwa n'ikigo cyabimenyesheje, kandi icyemezo kigomba kuba gifite inomero y'ikigo cyabimenyesheje, ni ukuvuga kode yihariye y'imibare ine.

（3） Ingero z'ibisabwa ku bikoresho byo kwirinda icyorezo

1. Udupfukamunwa tugabanyijemo udupfukamunwa two kwa muganga n'udupfukamunwa two kwirinda.

Dukurikije en14683, udupfukamunwa tugabanyijemo ibyiciro bibiri: ubwoko bwa I n'ubwoko bwa II / IIR. Agapfukamunwa k'ubwoko bwa I kabereye gusa abarwayi n'abandi bantu kugira ngo bagabanye ibyago byo kwandura no kwandura, cyane cyane mu gihe cy'indwara zandura cyangwa ibyorezo. Agapfukamunwa k'ubwoko bwa II gakoreshwa cyane cyane n'abaganga mu cyumba cyo kubaga cyangwa ahandi hantu ho kwa muganga hafite ibisabwa nk'ibyo.

2. Imyenda irinda: Imyenda irinda igabanyijemo imyenda irinda kwa muganga n'imyenda irinda umuntu ku giti cye, kandi ibisabwa mu kuyicunga bisa n'iby'udupfukamunwa. Igipimo cy'i Burayi cy'imyenda irinda kwa muganga ni en14126.

(4) Amakuru agezweho

EU 2017 / 745 (MDR) ni itegeko rishya ry’ibikoresho by’ubuvuzi by’Umuryango w’Ubumwe bw’u Burayi. Nk’uko byavuguruwe na verisiyo ya 93 / 42 / EEC (MDD), iri tegeko rizatangira gukurikizwa kandi rigashyirwa mu bikorwa byuzuye ku ya 26 Gicurasi 2020. Ku ya 25 Werurwe, Komisiyo y’Ubumwe bw’u Burayi yatangaje icyifuzo cyo gusubika ishyirwa mu bikorwa rya MDR umwaka umwe, cyatanzwe mu ntangiriro za Mata kugira ngo cyemezwe n’Inteko Ishinga Amategeko y’u Burayi n’Inama Njyanama mbere y’uko Gicurasi irangira. MDD na MDR byombi bivuga imikorere y’icyo gicuruzwa kugira ngo habeho ubuzima n’umutekano by’abagikoresha.