Nkhani

Pakadali pano, mliri watsopano wa coronavirus (COVID-19) ukufalikira. Kufalikira kwa dziko lonse lapansi kukuyesa kuthekera kwa dziko lililonse kulimbana ndi mliriwu. Pambuyo pa zotsatira zabwino zopewera ndi kuwongolera mliri ku China, mabizinesi ambiri akunyumba akufuna kutsatsa malonda awo kuti athandize mayiko ena ndi madera ena kuthana ndi mliriwu. Pa Marichi 31, 2020, Unduna wa Zamalonda, General Administration of Customs ndi State Drug Administration of China adapereka chilengezo chogwirizana pazida zachipatala zokhudzana ndi kupewa mliri wa coronavirus (monga zida zodziwira, zigoba zachipatala, zovala zodzitetezera kuchipatala, ma ventilator ndi ma thermometer a infrared), zomwe zimati kuyambira pa Epulo 1, ogulitsa zinthu zotere ayenera kutsimikizira kuti apeza satifiketi yolembetsa ya zida zachipatala ku China Ndipo akwaniritsa miyezo yaukadaulo ya mayiko kapena madera omwe akutumiza kunja. Makampani amatha kutulutsa katunduyo pokhapokha atatsimikiziridwa kuti ndi oyenerera.

Chilengezo chogwirizana chikusonyeza kuti China imayang'ana kwambiri ubwino wa zinthu zachipatala zomwe zimatumizidwa kunja. Izi ndi chidule cha mavuto ena omwe ndi osavuta kusokoneza akatumizidwa kunja ku European Union ndi ku United States.

mgwirizano wamayiko aku Ulaya

（1） Zokhudza chizindikiro cha CE

CE ndi gulu la anthu aku Europe. Chizindikiro cha CE ndi chitsanzo cha malamulo a EU pazinthu zomwe zalembedwa mu EU. Mu msika wa EU, satifiketi ya CE ndi ya satifiketi yokakamiza ya malamulo. Kaya zinthu zopangidwa ndi mabizinesi mkati mwa EU kapena zinthu zopangidwa m'maiko ena zikufuna kufalikira momasuka pamsika wa EU, chizindikiro cha CE chiyenera kupakidwa kuti chiwonetse kuti zinthuzo zikugwirizana ndi zofunikira zoyambira za njira yatsopano yolumikizirana ndi kukhazikika. Malinga ndi zofunikira za PPE ndi MDD / MDR, zinthu zomwe zimatumizidwa ku EU ziyenera kukhala ndi chizindikiro cha CE.

（2） Zokhudza Ziphaso

Kumata chizindikiro cha CE ndi gawo lomaliza malonda asanafike pamsika, zomwe zikusonyeza kuti njira zonse zatha. Malinga ndi zofunikira za PPE ndi MDD / MDR, zida zodzitetezera (monga chigoba chodzitetezera cha kalasi III) kapena zida zachipatala (monga kuyeretsa chigoba chachipatala cha kalasi I) ziyenera kuyesedwa ndi bungwe lodziwitsidwa (NB) lovomerezedwa ndi European Union. Satifiketi ya CE ya chipangizo chachipatala iyenera kuperekedwa ndi bungwe lodziwitsidwa, ndipo satifiketiyo iyenera kukhala ndi nambala ya bungwe lodziwitsidwa, ndiko kuti, nambala yapadera ya manambala anayi.

（3） Zitsanzo za zofunikira pa zinthu zopewera mliri

1. Zophimba nkhope zimagawidwa m'magulu awiri: zophimba nkhope zachipatala ndi zophimba nkhope zodzitetezera.

Malinga ndi en14683, masks amagawidwa m'magulu awiri: mtundu woyamba ndi wachiwiri / IIR. Chigoba cha mtundu woyamba ndi choyenera odwala ndi anthu ena okha kuti achepetse chiopsezo cha matenda ndi kufalikira, makamaka pankhani ya matenda opatsirana kapena miliri. Chigoba cha mtundu wachiwiri chimagwiritsidwa ntchito makamaka ndi akatswiri azachipatala m'chipinda chochitira opaleshoni kapena malo ena azachipatala omwe ali ndi zofunikira zofanana.

2. Zovala zodzitetezera: Zovala zodzitetezera zimagawidwa m'magulu awiri: zovala zodzitetezera zachipatala ndi zovala zodzitetezera, ndipo zofunikira pa kasamalidwe kake ndizofanana ndi za masks. Muyezo wa ku Ulaya wa zovala zodzitetezera zachipatala ndi en14126.

(4) Nkhani zaposachedwa

EU 2017 / 745 (MDR) ndi lamulo latsopano la zida zachipatala la EU. Monga mtundu wosinthidwa wa 93 / 42 / EEC (MDD), lamuloli lidzayamba kugwira ntchito ndipo lidzayamba kugwiritsidwa ntchito mokwanira pa Meyi 26, 2020. Pa Marichi 25, European Commission idalengeza lingaliro loti MDR iyambe kugwiritsidwa ntchito chaka chimodzi, lomwe lidaperekedwa koyambirira kwa Epulo kuti livomerezedwe ndi Nyumba Yamalamulo ya ku Europe ndi Bungwe lisanafike kumapeto kwa Meyi. MDD ndi MDR zonse ziwiri zimafotokoza momwe mankhwalawa amagwirira ntchito kuti zitsimikizire thanzi ndi chitetezo cha ogwiritsa ntchito.