Labarai

A halin yanzu, cutar sankara ta coronavirus (COVID-19) tana yaduwa. Yaduwar duniya tana gwada karfin kowace kasa don yakar cutar. Bayan da aka samu sakamako mai kyau na rigakafin kamuwa da cutar a kasar Sin, kamfanoni da yawa na cikin gida sun yi niyyar tallata kayayyakinsu don taimakawa sauran kasashe da yankuna tare da yin rigakafin cutar. A ranar 31 ga Maris, 2020, Ma'aikatar Kasuwanci, Babban Hukumar Kwastam da Hukumar Kula da Magunguna ta kasar Sin, sun ba da sanarwar hadin gwiwa kan na'urorin likitanci da suka shafi rigakafin kamuwa da cutar coronavirus (kamar na'urorin ganowa, abin rufe fuska na likitanci, tufafin kariya na likitanci, na'urorin hura iska da sauransu). Infrared thermometers), wanda ya kayyade cewa daga ranar 1 ga Afrilu, masu fitar da irin waɗannan kayayyaki dole ne su tabbatar da cewa sun sami takardar shaidar rajistar na'urorin kiwon lafiya a kasar Sin kuma sun cika ka'idodin ƙasashe ko yankuna masu fitar da kayayyaki. Hukumar kwastam za ta iya sakin kayan ne kawai bayan an tabbatar da cewa sun cancanta.

Sanarwar hadin gwiwa ta nuna cewa, kasar Sin na mai da hankali sosai kan ingancin kayayyakin jinya da ake fitarwa zuwa kasashen waje. Mai zuwa shine taƙaitawar wasu matsalolin da ke da sauƙin ruɗewa yayin fitar da kayayyaki zuwa Tarayyar Turai da Amurka.

Tarayyar Turai

(1) Game da alamar CE

CE ita ce al'ummar Turai. Alamar CE ita ce samfurin ƙa'ida ta EU don samfuran da aka jera a cikin EU. A cikin kasuwar EU, takardar shedar CE tana cikin takaddun ƙa'ida ta tilas. Ko samfuran da kamfanoni ke samarwa a cikin EU ko samfuran da aka samar a wasu ƙasashe suna son yaduwa cikin yardar kaina a cikin kasuwar EU, alamar CE dole ne a liƙa don nuna cewa samfuran sun cika ka'idodin sabuwar hanyar daidaita fasaha da daidaitawa. Dangane da buƙatun PPE da MDD / MDR, samfuran da aka fitar zuwa EU yakamata a yiwa alama CE.

(2) Game da Takaddun shaida

Manna alamar CE shine mataki na ƙarshe kafin samfurin ya shiga kasuwa, wanda ke nuna cewa an kammala duk hanyoyin. Dangane da buƙatun PPE da MDD / MDR, kayan kariya na sirri (kamar abin rufe fuska na aji III) ko kayan aikin likita (kamar cutar da abin rufe fuska na aji I) yakamata ƙungiyar da aka sanar (NB) ta amince da Tarayyar Turai. . Hukumar da aka sanar da ita ce ta ba da takardar shaidar CE ta na'urar likitanci, kuma takardar shaidar ta kasance tana da lambar jikin da aka sanar, wato lambar lambobi huɗu na musamman.

(3) Misalai na buƙatun samfuran rigakafin annoba

1. Masks sun kasu kashi kashi na likita da abin rufe fuska na sirri.

Dangane da en14683, masks sun kasu kashi biyu: nau'in I da nau'in II / IIR. Nau'in nau'in abin rufe fuska kawai ya dace da marasa lafiya da sauran mutane don rage haɗarin kamuwa da cuta da yaduwa, musamman a yanayin cututtukan cututtuka ko annoba. Nau'in nau'in abin rufe fuska na II ana amfani da shi ne ta likitocin likita a cikin dakin aiki ko wani wurin likita tare da buƙatu iri ɗaya.

2. Tufafin kariya: Tufafin kariya sun kasu kashi biyu na kayan kariya na likita da kuma tufafin kariya na sirri, kuma abubuwan da ake buƙata na sarrafa su suna kama da na abin rufe fuska. Matsayin Turai na tufafin kariya na likita shine en14126.

(4) Sabbin labarai

EU 2017/745 (MDR) sabon tsarin na'urar likitancin EU ne. A matsayin ingantacciyar sigar 93 / 42 / EEC (MDD), dokar za ta fara aiki kuma za a aiwatar da ita sosai a ranar 26 ga Mayu, 2020. A ranar 25 ga Maris, Hukumar Tarayyar Turai ta ba da sanarwar jinkirta aiwatar da MDR da shekara guda. wanda aka gabatar a farkon watan Afrilu don amincewa da Majalisar Turai da Majalisar Tarayyar Turai kafin karshen watan Mayu. Dukansu MDD da MDR sun ƙayyade aikin samfurin don tabbatar da lafiya da amincin masu amfani.