Tumizani Ku United States
Bungwe la US Food and Drug Administration (FDA) limati zida zachipatala, chakudya, mowa, mankhwala ndi mafakitale ena kunja kwa United States ziyenera kulembetsedwa ndipo nthumwi ya US iyenera kusankhidwa asanalembedwe ku United States.
21CFR Gawo 807.40 (A) imanena kuti wopanga aliyense waku America yemwe akuchita nawo ntchito yopanga, kukonza, kuphatikiza kapena kukonza zida zomalizidwa ndi kutumiza zinthu ku United States akuyenera kuchita Kulembetsa Kukhazikitsa ndi Mndandanda wa Zida Zachipatala.Polembetsa fakitale, wopanga amayenera kufotokoza zambiri za wothandizila waku US ku FDA mu fomu yamagetsi mu kaundula ndi ndandanda (FURLS system), kuphatikiza dzina, adilesi, foni, fax ndi imelo ya wothandizila waku US.
Pazogulitsa zilizonse, mabizinesi amayenera kulembetsa ndikulemba mndandanda wazogulitsa.
Pazinthu za Class I (zowerengera pafupifupi 47%), General Control imayikidwa.Zambiri mwazogulitsa zimatha kulowa mumsika waku US pongolembetsa, kulembetsa ndikukhazikitsa zomwe GMP (ochepa mwa iwo samasulidwa ku GMP, ndipo zochepa mwazogulitsa zomwe zasungidwa zimafunikira kutumiza mapulogalamu 510 (K) ku FDA, mwachitsanzo, PMN (Premarket Notification). ));
Tumizani Ku Japan
Makampani opanga zida zamankhwala omwe akufuna kuyika malonda awo pamsika waku Japan ayenera kukwaniritsa zofunikira za Japan Pharmaceutical And Medical Device Act (PMD Act).
Ngati Makampani Azida Zachipatala Akufuna Kuyika Zogulitsa Zawo Pamsika Waku Japan, Ayenera Kukwaniritsa Zofunikira za Pharmaceutical And Medical Device Act (PMD Act) yaku Japan.
Pharmaceutical and Medical Devices Agency (PMDA), dipatimenti yocheperako ya Ministry of Health, Labor And Welfare (MHLW), yafalitsanso malamulo ochepa mu Chingerezi.Komabe, zovuta za zilankhulo ndi njira zovuta zoperekera ziphaso zikadali zovuta pakulembetsa zida zachipatala ku Japan.
Mogwirizana ndi lamulo la PMD, kalembera wa TOROKU amafuna kuti opanga zinthu zapakhomo alembetse zidziwitso zafakitale ndi akuluakulu aboma omwe ali ndi chilolezo ndi boma, kuphatikiza kapangidwe kazinthu, kupanga ndi chidziwitso chofunikira;Opanga akunja ayenera kulembetsa zambiri za opanga ndi PMDA.
Pa Pempho la PMD Act, Toroku Registration System Imafuna Opanga Pakhomo Kuti Alembetse Zidziwitso Zamafakitale Ndi Akuluakulu Akuluakulu Ololedwa ndi Boma, Kuphatikizira Kapangidwe Kazogulitsa, Kupanga Ndi Chidziwitso Chofunikira;Opanga Akunja Ayenera Kulembetsa Zambiri Zopanga Ndi PMDA.
Kutumiza Ku South Korea
Unduna wa Zaumoyo (MHW) ku South Korea, womwe umatchedwa Unduna wa Zaumoyo mwachidule, ndiwo makamaka umayang'anira kayendetsedwe kazakudya, mankhwala, zodzoladzola ndi zida zamankhwala, ndipo ndi gawo lalikulu lazaumoyo.Malinga ndi Medical Device Law, Ministry of Food and Drug Safety (MFDS) yomwe ili pansi pa Unduna wa Zaumoyo ndi Welfare ku South Korea ndi yomwe imayang'anira zida zamankhwala.
The Korea Medical Device Law imayika zida zamankhwala m'magulu anayi (I, II, III, IV), omwe ali ofanana kwambiri ndi gulu la European Union la zida zamankhwala.
Lamulo la Zida Zachipatala zaku Korea Limagawa Zida Zachipatala M'magulu Anayi (I, II, III ndi IV), Zomwe Zili Zofanana Kwambiri ndi Gulu la European Union la Zida Zachipatala.
Kalasi I: zida zamankhwala zokhala ndi zoopsa zochepa;
Kalasi II: zida zamankhwala zokhala ndi chiopsezo chochepa;
Kalasi yachitatu: zida zamankhwala zokhala ndi zoopsa zochepa;
Kalasi IV: Zida zamankhwala zowopsa kwambiri.
Kuyika maziko a zida zamankhwala: digiri yowopsa, malo olumikizirana ndi nthawi ndi thupi la munthu, chitetezo ndi magwiridwe antchito azinthu.
Zida za Class I ndi II zidzatsimikiziridwa ndi "Medical Device Information Technology Support Center (MDITAC)", ndipo zida zina za Class II (zida zatsopano), Class III ndi Class IV zidzavomerezedwa ndi Korea Food and Drug Safety Administration.
Zida zonse zamankhwala zomwe zimatumizidwa ku Australia ziyenera kulembetsa kulembetsa kwa TGA.TGA ndiye chidule cha Therapeutic Goods Administration.Dzina lake lonse ndi Therapeutic Goods Administration.Ndilo bungwe loyang'anira zinthu zochizira (kuphatikiza mankhwala, zida zamankhwala, ukadaulo wa majini ndi zinthu zamagazi) ku Australia.
Tanthauzo la zida zamankhwala ku Australia ndi pafupi ndi CE of EU, ndipo gululi limagwirizana.Mosiyana ndi US FDA, mitundu ya nyama siyoyendetsedwa ndi TGA.Zofanana ndi FDA, muyenera kufotokoza m'badwo
Zofunika Mask
NIOSH (National Institute of Occupational Safety And Health) Imagawa Zopumira Zake Zotsimikizika M'magulu 9 Molingana ndi Malamulo a HHS.Satifiketi Yotsimikizika Imayendetsedwa ndi Npptl Laboratory Pansi pa NIOSH.
Ku United States, Molingana ndi Kuchita Bwino Kochepa Kwa Sefa Zosefera, Masks Atha Kugawidwa M'magiredi Atatu - N, R, P.
Masks a M'kalasi N Amatha Kusefa Tinthu Zopanda Mafuta, Monga Fumbi, Chifunga Cha Acid, Paint Mist, Microorganism, Etc. Tizigawo Zoyimitsidwa Pakuipitsa Mpweya Nthawi zambiri Sizikhala Mafuta.
R Chigoba Ndi Choyenera Kusefa Tizidutswa Za Mafuta Ndi Tinthu Zopanda Mafuta, Koma Nthawi Yochepa Yogwiritsa Ntchito Tizigawo Za Mafuta Sizidzapitirira Maola 8.
Masks a Class P Atha Kusefa Zonse Zopanda Mafuta Ndi Tinthu Zamafuta.Tizilombo ta Mafuta Monga Utsi Wa Mafuta, Nkhungu Ya Mafuta, Etc.
Malinga ndi Kusiyana Kwa kusefera Mwachangu, Pali Kusiyana kwa 90,95100, Motsatana, Zomwe Zimatanthawuza Kuchita Zochepa Zosefera Za 90%, 95%, 99.97% Pansi Pamayeso Ofotokozedwa Mu Muyeso.
N95 Si Dzina Lachindunji.Bola Zomwe Zimakumana ndi N95 Standard Ndikudutsa Ndemanga ya NIOSH, Ikhoza Kutchedwa "N95 Mask".
Australia:
Zofunikira (Zofunikira)
Bill of Lading, Packing List, Invoice
Zofunika Mask
Monga / NZS 1716:2012 Ndi Chida Chotetezera Kupuma Ku Australia Ndi New Zealand.Njira Yopangira Ndi Kuyesa Kwazinthu Zofunikira Ziyenera Kutsatira Izi.
Mulingo Uwu Umafotokoza Njira Ndi Zida Zomwe Zikuyenera Kugwiritsidwa Ntchito Popanga Ma Particle Respirators, Komanso Mayeso Otsimikizika Ndi Zotsatira Zamagwiridwe Kuti Atsimikizire Kugwiritsa Ntchito Kwawo Chitetezo.
Kutumiza Kwawekha:
Panopa, Cross-Border E-Commerce Simalamulira Kutumiza Kwazinthu Zotsutsana ndi Mliri Monga Masks.Ngati Chiwerengero Cha Masks Chili M'njira Yoyenera, Masks Atha Kutumizidwa Kumayiko Akunja Ndi Post Yanu.Ngakhale Maiko Ambiri Amasiya Kutumiza Maimelo ku China, Sasiya Kulandira Maimelo ndi Kutumiza Kwa Express Kuchokera ku China.Komabe, Zofunikira Payekha Payekha Payekha Padziko Lonse Ndi Zosiyana, Chifukwa chake Chonde Onani Zofunikira Zadziko Lonse Musanatumize.
Ndemanga za Mkonzi:
1. Popeza Zofunikira za Dziko Lililonse Pa Masks Ochokera Kumayiko Ena Ndi Zosiyana, Muyenera Kuwonana ndi Kampani Yamaofesi Yapafupi Kapena Kampani Yolandira Musanayambe Kutumiza Kupewa Vuto Lazinthu Zoletsedwa Kapena Kubwezeredwa.
2. Chiwerengero cha Masks Odzigwiritsa Ntchito Pawekha Ndi Kutumiza Kumayiko Akunja Ayenera Kukhala M'kati Mwazokwanira.Ngati Nambalayo Ndi Yaikulu, Itha Kugwidwa Ndi Miyambo Yachilendo.
3. Panopa, The Air ndi Nyanja Transportation Mphamvu Sizinabwezeretsedwe, Choncho Current Transportation Time Ndi yaitali.Aliyense Ayenera Kulabadira Kusintha Kwa Nambala Ya Waybill Pambuyo Pakutumizidwa, Komanso Khalani Oleza Mtima.Malingana Ngati Palibe Kuphwanya, Sidzamangidwa Kapena Kubwezeredwa.
Kusindikizidwanso Kwa Nkhaniyi.Ngati Pali Cholakwa Chilichonse Kapena Kuphwanya, Chonde Lumikizanani Nafe Kuti Mukonze
Nthawi yotumiza: Mar-16-2020
