Export KuUnited States
Sangano reUS Food and Drug Administration (FDA) rinoti midziyo yekurapa, chikafu, doro, zvinodhaka nezvimwe zviri kunze kweUnited States zvinofanirwa kunyoreswa uye mumiriri weUS anofanirwa kugadzwa zvisati zvanyorwa muUnited States.
21CFR Chikamu 807.40 (A) inotaura kuti chero mugadziri weAmerica mhiri kwemakungwa ane chekuita nekugadzira, kugadzirira, musanganiswa kana kugadzirisa zvigadzirwa zvekurapa zvakapedzwa uye zvigadzirwa zvekunze kuUnited States zvinofanirwa kuita Kunyoreswa Kwekumisikidzwa uye Kunyoreswa Kwemidziyo Yekurapa.Paunenge uchinyoresa fekitori, mugadziri anofanirwa kuudza ruzivo rwemumiriri weUS kuFDA nenzira yemagetsi mukunyoresa uye kunyora system (FURLS system), kusanganisira zita, kero, runhare, fax uye email yemumiriri weUS.
Kune chero chigadzirwa, mabhizinesi anofanirwa kunyoresa uye kunyora zvigadzirwa.
Kune zvigadzirwa zveKirasi I (accounting ye47%), General Control inoiswa.Zvizhinji zvezvigadzirwa zvinogona kupinda mumusika weUS chete nekunyoresa, kunyora uye kuita zvakatemwa zveGMP (vashoma vacho vanoburitswa kubva kuGMP, uye zvishoma zvezvakachengetwa zvigadzirwa zvinofanirwa kuendesa 510 (K) zvikumbiro kuFDA, kureva PMN (Premarket Notification. ));
Export KuJapan
Makambani emidziyo yekurapa anoda kuisa zvigadzirwa pamusika weJapan anofanirwa kuzadzisa zvinodiwa neJapan Pharmaceutical And Medical Device Act (PMD Act).
Kana Makambani eMichina Yezvokurapa Vachida Kuisa Zvigadzirwa Zvavo Mumusika weJapan, Vanofanirwa Kuzadzisa Zvinodikanwa zveMishonga Uye Chirwere Chishandiso Mutemo (PMD Act) weJapan.
Pharmaceutical and Medical Devices Agency (PMDA), dhipatimendi riri pasi reMinistry of Health, Labor And Welfare (MHLW), rakaburitsawo nhamba diki yemirairo muChirungu.Nekudaro, matambudziko emutauro uye akaomesesa certification maitiro achiri chinhu chakaoma pakunyoreswa kwemidziyo yekurapa muJapan.
Pasi pezvinodiwa zvePMD Act, chirongwa chekunyoresa cheTOROKU chinoda kuti vagadziri vedzimba vanyore ruzivo rwefekitori nevane masimba venzvimbo vakatenderwa nehurumende, kusanganisira magadzirirwo echigadzirwa, kugadzira uye ruzivo rwakakosha;Vagadziri vekunze vanofanirwa kunyoresa ruzivo rwemugadziri nePMDA.
Pachikumbiro chePMD Act, Toroku Registration System Inoda Vagadziri Vemumba Kunyoresa Ruzivo rweFekitori NeVakuru Venzvimbo Vakatenderwa neHurumende, Kusanganisira Chigadzirwa Dhizaini, Kugadzira Uye Ruzivo Rwakakosha;Vagadziri Vekunze Vanofanirwa Kunyoresa Ruzivo rweVagadziri nePMDA.
Export KuSouth Korea
Ministry of Health Welfare (MHW) muSouth Korea, inodaidzwa sekuti Ministry of Health kwenguva pfupi, inonyanya kuita basa rekutonga kwechikafu, zvinodhaka, zvekuzora nemidziyo yekurapa, uye ndiro chikamu chikuru chehutano.Sekureva kweMedical Device Law, Ministry of Food and Drug Safety (MFDS) iri pasi peBazi reHutano neWelfare yeSouth Korea ine basa rekutariswa kwemidziyo yekurapa.
Mutemo weKorea Medical Device unoisa midziyo yekurapa muzvikamu zvina (I, II, III, IV), izvo zvakada kufanana neEuropean Union kupatsanurwa kwemidziyo yekurapa.
Korean Medical Devices Mutemo Unokamura Zvishandiso Zvekurapa Muzvikamu zvina (I, II, III uye IV), Izvo Zvakanyanya Kufanana Nekurongwa kweEuropean Union Kwemichina Yekurapa.
Kirasi I: zvishandiso zvekurapa zvine njodzi shoma inogona kuitika;
Kirasi II: zvishandiso zvekurapa zvine njodzi yakaderera;
Kirasi III: midziyo yekurapa ine mwero inogona kuva nengozi;
Kirasi IV: Zvishandiso zvekurapa zvine njodzi.
Classification hwaro hwezvishandiso zvekurapa: dhigirii renjodzi, nzvimbo yekuonana uye nguva nemuviri wemunhu, kuchengetedza uye kushanda kwezvigadzirwa.
Kirasi I uye II michina ichasimbiswa ne "Medical Device Information Technology Support Center (MDITAC)", uye imwe Kirasi II (michina mitsva), Kirasi III uye Kirasi IV michina ichabvumidzwa neKorea Chikafu uye Drug Safety Administration.
Zvese zvishandiso zvekurapa zvinotumirwa kuAustralia zvinoda kunyorera kunyoresa kweTGA.TGA ndiyo chidimbu cheTherapeutic Goods Administration.Zita rayo rakazara ndiro Therapeutic Goods Administration.Isangano rinoona nezvekurapa (kusanganisira zvinodhaka, midziyo yekurapa, genetic tekinoroji uye zvigadzirwa zveropa) muAustralia.
Tsanangudzo yezvishandiso zvekurapa muAustralia iri padyo neEC yeEU, uye kupatsanurwa kunoenderana.Yakasiyana neUS FDA, mhando dzemhuka hadzidzorwe neTGA.Zvakafanana neFDA, unofanirwa kutsanangura chizvarwa
Mask Zvinodiwa
NIOSH (National Institute Of Occupational Safety And Health) Inoisa Mafemero Ayo Akasimbiswa Muzvikamu 9 Zvinoenderana neHHS Regulations.Iyo Yakasarudzika Certification Inoitwa neNpptl Laboratory Pasi peNIOSH.
MuUnited States, Zvinoenderana Neiyo Minimum Filtration Kushanda Kwesefa Material, Masks Anogona Kukamurwa MuMagiredhi Matatu - N, R, P.
Masiki eKirasi N Anogona Chete Kusefa Zvisiri Zvisina Mafuta, Zvakaita Seguruva, Asidhi Mhute, Pendi Mhute, Microorganism, Etc. MaPaleki Akambomiswa MuKusvibiswa Kwemhepo Haanyanye Kusina Mafuta.
R Mask Inongokodzera Kusefa Mafuta uye Masiri Maorivhi, asi Iyo Yakaganhurirwa Yekushandisa Nguva YeMafuta Haapfuure Maawa masere.
Kirasi P Masks Anogona kusefa ese ari maviri Asiri Maorivhi Particles uye Oiri Particles.Zvimedu zvine Mafuta zvakadai seOiri Utsi, Oiri Mhute, Etc.
Zvinoenderana NeMusiyano Wekusefa Kubudirira, Kune 90,95100 Misiyano, zvichiteerana, Iyo Inoreva Iyo Yakaderera Filtration Kushanda Kwe90%, 95%, 99.97% Pasi Peiyo Yebvunzo Mamiriro Akatsanangurwa Muiyo Standard.
N95 Haisi Yakananga Chigadzirwa Zita.Chero bedzi Chigadzirwa Chinosangana NeN95 Yakajairwa Uye Yakapfuura Iyo NIOSH Ongororo, Inogona Kunzi "N95 Mask".
Ositireriya:
Ruzivo runodiwa (Kufanirwa)
Bhiri rekutakura, Rondedzero yekurongedza, invoice
Mask Zvinodiwa
Sezvo / NZS 1716: 2012 Iri Kufuridzira Kudzivirira Chishandiso Chiyero muAustralia neNew Zealand.Iyo Yekugadzira Maitiro uye Kuedzwa Kwezvishandiso Zvakakodzera Zvinofanirwa Kuenderana Neiyi Yakatsanangurwa.
Iyi nhanho Inotsanangura Maitiro uye Zvishandiso Zvinofanirwa Kushandiswa Mukugadzira Maitiro eParticle Respirators, pamwe neyakatemerwa Muedzo uye Maitiro ekuita kuti ave nechokwadi chekushandisa kwavo kuchengetedza.
Tsamba Yako
Parizvino, Cross-Border E-Commerce Haidzore Kutengeswa KweAnti Epidemic Zvishandiso SeMasks.Kana Huwandu hweMasks huri mukati meiyo inonzwisisika Range, Masks anogona kutumirwa kune dzimwe nyika nekutumira.Kunyangwe Nyika Dzakawanda Dzinomira Kutumira Tsamba kuChina, Ivo havaregi Kugamuchira Tsamba uye Express Delivery Kubva kuChina.Zvisineyi, Zvinodiwa Zvekupinza Munyika Yega Yega zvakasiyana, saka Ndokumbira utarise Izvo Zvinodiwa Nenyika Usati Watumira.
Chiziviso cheMupepeti:
1. Sezvo Zvinodiwa Zvenyika Yese Kune Masks Anotengeswa Kunze Zvakasiyana, Unofanira Kubvunza Kambani Yemumiririri Wenzvimbo Kana Kambani Inotambira Usati Watumira kunze Kuti Udzivise Dambudziko Rezvinhu Kunyimwa Kana Kudzorerwa.
2. Nhamba yeMasks Yekuzvishandisa uye Export Inofanirwa Kuve Mukati Inonzwisisika Range.Kana Nhamba yacho Yakakura, Inogona Kubatwa Netsika dzeKune dzimwe nyika.
3. Parizvino, Kukwanisa Kwekufambisa Kwemhepo Nemugungwa Hakusati Kwadzorerwa, Saka Nguva Yazvino Yekufambisa Yakareba.Wese Munhu Anofanirwa Kuteerera Kuchinja KweNhamba yeWaybill Mushure meKuendeswa, Uye zvakare Iva nemoyo murefu.Chero Pakange Pasisina Kutyora, Hachizosungwa Kana Kudzorerwa.
Kudhindwazve Kwechinyorwa ichi.Kana Pane Chero Chikanganiso Kana Kukanganisa, Ndokumbira Tibate Kuti Tigadzirise
Nguva yekutumira: Mar-16-2020
