1, Chii Chinosiyanisa Kuzivikanwa Kwemidziyo Yekurapa?
Iyo Yakasarudzika Kuzivikanwa Kwezvokurapa Zvishandiso Inosanganisira Chigadzirwa Kuzivikanwa uye Kuzivikanwa Kwekugadzira.Iyo Chigadzirwa Kuzivikanwa Ndiyo Yakasarudzika kodhi Kuziva Akanyoresa / Filer, Modhi, Matsanangudzo uye Package Yezvokurapa Zvishandiso.Ndiro "Keyword" Kuti Uwane Ruzivo rwakakodzera rweMadhivhisi ekurapa kubva kuDatabase, uye ndicho chikamu chinodiwa cheiyo Yakasarudzika Kuzivikanwa.Iyo Kuzivikanwa Kwekugadzira Kunosanganisira Ruzivo rwakanangana neKugadzira Maitiro, Kusanganisira Chigadzirwa Batch Nhamba, Nhamba Yeseri Uye Zuva Rokugadzira Nguva Uye Kupera Kwemazuva, Etc., Inogona Kushandiswa Mukubatana Nechigadzirwa Chiziviso Kuzadzisa Zvinodiwa Zvekuzivikanwa Kwakanaka Uye Rekodha Mukutenderera Uye Kushandisa Zvishandiso Zvekurapa.
Nheyo Yekusiyana, Kugadzikana uye Scalability.Kusiyana Ndiyo Yekutanga Nheyo, hwaro hwekuva nechokwadi chekuzivikanwa chaiko kweZvigadzirwa, uye Iyo yakakosha Musimboti weBasa reKuzivikanwa Kwakasarudzika.Nekuda kwekuoma kweMichina Yezvokurapa, Iyo Yakasarudzika Ichaenderana Nezvinodikanwa Zvechigadzirwa Kuzivikanwa.Kune Midziyo Yezvokurapa Ine Hunhu Hwakafanana, Iyo Yakasiyana Ichanongedza kune Imwe Yakatsanangurwa Uye Muenzanisi Chigadzirwa;Kune Zvigadzirwa Zvinodzorwa NeBatch Production, Iyo Yakasiyana Ichanongedza kune Iyo Same Batch Yezvigadzirwa;Kune Zvishandiso Zvekurapa Zvinodzorwa NeSerial Nhamba Kugadzirwa, Iyo Yakasarudzika Inonongedzera kune Chimwe Chigadzirwa.
Kugadzikana Kunoreva Kuti Kana Iyo Yakasarudzika Identification Yakapihwa kune Chigadzirwa Chishandiso Chekurapa, Chero bedzi Hunhu Hwayo Husina Kuchinja, Kuzivikanwa Kwechigadzirwa Kunofanira Kuramba Kusina Kuchinja.Kana Kutengeswa uye Kushandiswa Kwemidziyo Yekurapa Kwamiswa, Chigadzirwa Chiziviso Hachizoshandiswe Kune Zvimwe Zvishandiso Zvekurapa;Kana Kutengesa uye Kushandiswa Kwatangazve, Iyo Yekutanga Chigadzirwa Kuzivikanwa Inogona Kushandiswa.
Extensibility Inoreva Kuti Iyo Yakasarudzika Kuzivikanwa Inofanirwa Kuchinjika kune Izvo Zvinotarisirwa Zvinodiwa uye Kuenderera Kunoenderera Kwekuvandudza Kunoshanda Zvishandiso.Izwi rekuti "Yakasarudzika" hazvireve kuti Iyo Serial Nhamba Management Yechimwe Chigadzirwa Inoitwa.MuIyo Yakasarudzika Kuzivikanwa, Iyo Yekugadzira Identification Inogona Kushandiswa Mukubatana Neiyo Chigadzirwa Kuzivikanwa Kuti Uwane Kusiyana Kwematanho Matatu: Kutsanangurwa, Modhi, Batch uye Imwe Chigadzirwa, Kuti Sangana Nezvazvino uye Zveramangwana Zvinodiwa Zvekurapa Zvishandiso Ziva Zvinodiwa.
2, Sei Kuvaka Yakasiyana Identification System Yezvokurapa Zvishandiso?
Medical Tekinoroji, Zvinodhaka Uye Zvishandiso Zvekurapa Ndidzo Mbiru Matatu eiyo Medical Service System.Midziyo Yezvokurapa Inosanganisira Ruzha, Chiedza, Magnetism, Mufananidzo, Zvishandiso, Mechanics Uye Dzinoda kusvika Mazana Inyanzvi Dzidziso.Iwo Anocherechedzwa Pasi Pose Maindasitiri Epamusoro-Tekinoroji, Ane Hunhu Hwepamusoro-Tech Intensive, Interdisciplinary, Technology Integration uye Kubatanidzwa, Uye Anomiririra Kusimba Kwakazara Kwenyika Yepamusoro-Tech.Mumakore Achangopfuura, NeKukurumidzira Kubudirira Kweindasitiri Yechishandiso Chishandiso, Tekinoroji Hutsva Uye Zvigadzirwa Zvinobuda Murukova Rusingaperi, Uye Kusiyana Kwechigadzirwa Uye Kuoma kuri Kugara Kuvandudza.Iko hakuna kodhi kana chinhu chimwe chine akawanda makodhi mukutenderera uye kushandiswa kwemidziyo yekurapa, iyo inokanganisa zvakanyanya kuzivikanwa kwezvishandiso zvekurapa mukugadzira, kutenderera uye kushandiswa kwezvishandiso zvekurapa, uye zvinonetsa kuwana.
Yakasarudzika Device Identification (UDI) Iyo ID Kadhi Yemidziyo Yekurapa.Iyo Yakasarudzika Identification System Yezvokurapa Zvishandiso Inosanganisira Yakasiyana Kuzivikanwa, Data Carrier uye Database.Kupa Chishandiso Chese Chekurapa Kadhi, Kuona Kujeka uye Kuonekwa Kwekugadzira, Kushanda uye Kushandisa, uye Kuvandudza Kuteedzera Kwezvigadzirwa Ndiwo Kiyi yekuvandudzwa kweMedhiyo Yekutarisira Chishandiso Zvinoreva uye Kuvandudzwa Kwekutarisisa Kushanda.Ichatamba Basa Rakanaka Mukunyatsoteerera Nepazasi Mutsetse Wekuchengetedzwa Kwechishandiso Chekurapa Uye Kubatsira Iyo Yepamusoro-Unhu Kukudziridzwa kweIndasitiri Yemidziyo Yekurapa.Naizvozvo, Iko Kuvakwa Kweiyo Yakasarudzika Identification System Yezvokurapa Zvishandiso muChina Iri Kuchimbidza Kudiwa.
Iyo Yakasiyana Kuzivikanwa Yezvokurapa Zvishandiso Ndiyo Inotarisisa Uye Inopisa Spot Munda weInternational Medical Device Regulation.Muna 2013, The International Medical Device Regulatory Body Forum (Imdrf) Yakapa Nhungamiro Yeiyo Unique Identification System Yezvokurapa Zvishandiso.Mugore rimwe chetero, United States Yakapa Mitemo Paiyo Yakasarudzika Identification System Yezvokurapa Zvishandiso, Inoda Kuitwa Kwakazara Kweiyo Yakasarudzika Identification System Yezvokurapa Zvishandiso Mukati Makore 7.Muna 2017, EU Mitemo Inodiwa Kuitwa Kweiyo Yakasiyana Kuzivikanwa Kwemidziyo Yekurapa.Japan, Australia, Argentina uye Dzimwe Nyika Dzakaitawo Basa Rakakodzera, Uye Kuzivikanwa Kwepasi Pose Kwezvishandiso Zvekurapa Kwave Kuchisimudzirwa.
Muna 2012, The State Council Yakapa The National Drug Safety Plan Yechigumi nemaviri Chirongwa cheMakore mashanu, Iyo Yaidana "Kutangisa Iyo National Unified Coding yeHigh-Risk Medical Devices".Muna 2016, The State Council Yakapa The 13th Five Year Plan YeNational Drug Safety, Inoda "Kuvaka A Medical Device Coding System uye Kugadzira Mitemo Yekurapa Chishandiso Coding".Muna 2019, Iyo General Hofisi yeThe State Council Yakapa Mabasa Akakosha Ekudzika Shanduko yeChiremba uye Hutano System muna 2019, Inoda "Kugadzira Iyo Mitemo Yeiyo Yakasarudzika Identification System yeMichina Yezvokurapa", Iyo Yakarongwa Uye Yakatenderwa Ne. Musangano wechisere weCentral Comprehensive Deepening Reform Committee.Mu "Chirongwa cheReform yeKurapwa Kwepamusoro-Kukosha Kwemishonga Consumables" Yakapihwa neGeneral Hofisi yeHurumende Council, Inoisa Pamberi Mberi "Kugadzira Iyo Yakasiyana Identification System Yezvokurapa Zvishandiso" Mitemo Yakabatana ". Muna Chikunguru 2019, Iyo State Chikafu. Uye Drug Administration, pamwe neNational Health and Health Commission, Vakabatana Vakaburitsa Chirongwa cheBasa rePilot Yeiyo Yakasarudzika Kuzivikanwa Sisitimu Yemidziyo Yekurapa, ichicherekedza Kutanga Kwekuvaka Kweiyo Yakasiyana Identification System yeMichina Yekurapa muChina.
3, Chii Chakakosha Kwekuvaka Yakasiyana Identification System Yemichina Yekurapa?
Kuburikidza nekugadzwa kweiyo yakasarudzika yekuzivikanwa sisitimu yezvishandiso zvekurapa, inokodzera kubatanidzwa uye nekugovaniswa kweiyo dhata, iyo Innovation yeRegulatory Model, Kuvandudzwa kweKushanda Kwemitemo, Kusimbiswa kweHupenyu Kutenderera Kwematanho eMidziyo Yekurapa, Kucheneswa kwe. Musika, Kukwidziridzwa kweBusiness Environment, Iko kusanganiswa kweHurumende Regulation uye Social Governance, Kuumbwa Kwenzvimbo yeSocial Governance, Kusimudzira Shanduko Yemaindasitiri, Kukwidziridza uye Hutano Hutano, Uye Kupihwa Kwezvimwe Tichawedzera Akachengeteka Uye Anoshanda Masevhisi Ekurapa. Uye Kuwedzera Pfungwa Yevanhu Yekusvika.
Kubva kuIndasitiri Yekuona, YeVagadziri veDhidhiyo Yezvokurapa, Iko Kushandiswa Kweiyo Yakasarudzika Logo Inobatsira Kuvandudza Iyo Yenhanho Yebhizinesi Ruzivo Management, Kumisikidza A Chigadzirwa Traceability System, Kusimbisa Indasitiri Kuzvibata, Kuvandudza Bhizinesi Management Kubudirira, Uye Kusimudzira Iyo Yepamusoro- Kuvandudzwa Kwemhando Yeindasitiri Yemidziyo Yekurapa.Kune Medical Device Bhizinesi Mabhizinesi, Iko Kushandiswa Kwekuzivikanwa Kwakasarudzika Kunogona Kugadzira Yemazuva Ano Logistics Sisitimu, Uye Kuziva Kujeka, Kuona uye Hungwaru Kweiyo Medical Device Supply Chain.Kune Masangano Ekurapa, Kushandiswa Kwekuzivikanwa Kwakasarudzika Kunobatsira Kudzikisa Zvikanganiso Zvechishandiso, Kuvandudza Chikamu Chekutonga Kwezvinobatika Muchipatara, Uye Kuchengetedza Kuchengetedzeka Kwevarwere.
Kubva paMaonero eHurumende manejimendi, Yekutariswa Kwemichina Yekurapa, Iko Kushandiswa Kwekuzivikanwa Kwakasarudzika Kunogona Kuvaka Yakakura Dhata Yekutariswa Kwemichina Yekurapa, Ziva Kwainobva Michina Yekurapa Inogona Kutariswa, Kwainoenda Inogona Kuteverwa, Basa Rinogona Kuve. Kuongororwa, Uye Kuziva Hungwaru Kutarisira.KuDhipatimendi Rehutano Hwehutano, Kushandiswa Kwekuzivikanwa Kwakasarudzika Kunogona Kusimbisa Iyo Yakamisikidzwa Management Yezvokurapa Equipment Behavior, Kusimudzira Kugadzwa Kwehutano Hwehutano Huru Data, Kuvandudza Kuita Kwehutano Management, Uye Kubatsira Hutano China Strategy.Kune Dhipatimendi reInishuwarenzi Yezvokurapa, Inobatsira Kunyatso Kuziva Zvishandiso Zvekurapa Mukutenga Kwekutenga, Kusimudzira Kujeka Kwekugadzirisa, Uye Kurwisa Hutsotsi uye Kushungurudzwa.
Kubva paMaonero Eruzhinji, Kuburikidza Nekuburitswa Kweruzivo uye Kugovaniswa Kwedata, Vatengi Vanogona Kushandisa uye Kunzwisisa Kushandiswa Kwakareruka, Uye Nekuchengetedzeka Kuchengetedza Kodzero Zviri pamutemo Uye Zvido zveVatengi.
4, Ndeapi Mamisimboti Ekuita Kwekuzivikanwa Kwakasarudzika Kwemichina Yekurapa?
Iyo Mitemo Yeiyo Yakasarudzika Kuzivikanwa Sistimu Yemidziyo Yezvokurapa (Pano Inozotaurwa SeMitemo) Inoda Kuti Kuvakwa Kweiyo Yakasarudzika Kuzivikanwa Sistimu Inofanirwa Kudzidza Kubva Kunyika Dzepasi Pose uye Kutevedzera Nheyo dzeKutungamira kweHurumende, Kuitwa kweBhizinesi, Kukurudzira Kwese uye Kuparadzira Kuitwa.Kuti Kusimudzire Zvirinani Kuchinjana Nekutengeserana Kwenyika Dzepasi Pose, Uye Kukwidziridza Nzvimbo YeBhizinesi, Kuvaka KweChina Yakasiyana Kuzivikanwa System Kunotora Zvidzidzo Kubva Kunyika Dzakagamuchirwa Misimboti Nemaitiro.Gadzira Yakasarudzika Yekuzivikanwa Sisitimu, Hurumende Inotamba Basa Rinotungamira, Iye Akanyoresa / Rekodhi SeMunhu Wekutanga Ane Mutoro Wekuita, Uye Shandisa Nesimba Kuzivikanwa Kwakasarudzika Kuvandudza Chigadzirwa Hunhu Uye Bhizinesi Management Level.Nekuda kweKusiyana-siyana uye Kuomarara Kwemichina Yekurapa, Kuitwa Kwekuzivikanwa Kwakasarudzika Nhanho Nenhanho Kuita Inogamuchirwa Pasi Pose.Zvishandiso zvekuChina zvekurapa zvinotungamirwa zvinoenderana neNzvimbo Yenjodzi.Kubva pane Chiitiko Chinoshanda cheiyo Yepasirese Yakasiyana Kuzivikanwa, Yakasanganiswa neChaicho Mamiriro eChina Medical Chishandiso Indasitiri uye Tarisiro, Nhanho-Ne-Nhanho Yekuita Porisi Yakagadzirwa.Kuenzaniswa neUnited States neEurope, Kuitwa Kwekuzivikanwa Kwakasarudzika muChina Kwakawedzera Iyo Pilot Link, Kunyanya Mamwe-Yakanyanya-Njodzi Kudyara / Inopindira Midziyo Yekurapa, Ine Diki Kuvharwa, Kuve nechokwadi Kufambira mberi Kwakasimba Kwemitemo.
5, Maitiro Ekuziva Iyo Aggregation uye Kugovana YeYakasarudzika Identification Data?
Iko Kuunganidzwa kweData uye Kugovaniswa Kweiyo Yakasarudzika Kuzivikanwa Kwezvishandiso Zvekurapa Zvinoitika Kuburikidza Neiyo Yakasarudzika Kuzivikanwa Dhatabhesi Yemidziyo Yekurapa, Iyo Yakarongwa uye Yakagadzirwa neHurumende Drug Administration.Iye Registrant / Recorder Inoisa Iyo Chigadzirwa Identification uye Ruzivo rwakabatana rweiyo Yakasarudzika Identification kuDatabase Zvinoenderana Neakakodzera Mayero uye Matsanangudzo, uye ane basa rekurongeka uye kusiyanisa kweiyo data.Medical Device Business Enterprises, Medical Institutions, Akakodzera Madhipatimendi eHurumende Uye Veruzhinji Vanogona Kugovera Yakasiyana Kuzivikanwa Dhata Kuburikidza neData Query, Dhawunirodha, Data Docking Uye Dzimwe Nzira.
6, Ko Izvo Zvigadzirwa Zvakanyorwa Pasati Paitwa Mitemo Inoda Kupihwa Yakasiyana Identification?
Kubva paZuva Rekuita KweMitemo, Iye Akanyoresa / Filer Achaendesa Chigadzirwa Chayo MuKunyoresa / Kuisa Management System PaKunyorera Kunyoreswa, Kunyoreswa Shanduko Kana Kufaya Kweakakodzera Zvishandiso Zvekurapa.Izvo Zvakakodzera Zvokurapa Zvigadzirwa Zvichapihwa Yakasarudzika Kuzivikanwa Panguva Yekugadzira Maitiro, Uye Kukwidzwa Kweiyo Yakasarudzika Identification Chigadzirwa Kuzivikanwa uye Inoenderana Dhata Yechishandiso Chekurapa Ichapedzwa Zvigadzirwa Zvisati Zviiswa Pamusika.
Midziyo Yezvokurapa Yakagadzirwa Uye Yakatengeswa Zuva Rekuita ReMitemo risati raitwa zvinogona kunge Zvisina Kuzivikanwa Kwakasiyana Kwemichina Yekurapa.
7, Maitiro Ekusarudza Iyo Yakasarudzika Identification Dhata Inotakura YeMidziyo Yekurapa?
Parizvino, Iyo Yakajairwa Dhata Inotakura Pamusika Inosanganisira Imwe-Dimensional Code, Mbiri-Dhimensional Code Uye Radio Frequency Tag (RFID).
Imwe Dimensional Kodhi iBarcode Symbol Inongomiririra Ruzivo Mune Imwe Dimensional Direction.Yakashandiswa Kwemakore Akawanda Uye Iine Mutengo Wakaderera.Inogona kunyatso kuenderana neiyo iripo kodhi yekuongorora Equipment Pamusika, asi Imwe-Nzira kodhi Inotora Nzvimbo Yakakura uye Iine Hurombo Kugadzirisa Kukuvadza.
Maviri Dimensional Kodhi Ibha Kodhi Chiratidzo chinomiririra Ruzivo mune Maviri-Dimensional Direction.Kuenzaniswa neOne-Dimensional kodhi, Iyo Imwechete Nzvimbo Inogona Kugarisa Yakawanda Dhata, Iyo Inogona Kutamba Basa Rakanaka Kana Iyo Packaging Saizi Yechishandiso Yakaganhurirwa.Iyo Iine Imwe Mhosho Kururamisa Kugona, Asi Zvinodiwa Zvekuverenga Equipment Zvakakwirira Kupfuura One-Dimensional Code.
Iyo RFID Tag Ine Basa reKuchengeta Ruzivo, Iyo inogona Kugamuchira Iyo Electromagnetic Modulation Signal yeMuverengi uye wodzokera kune Iyo Data Inotakura yeInoenderana Signal.Kuenzaniswa neOne-Dimensional kodhi uye maviri-dimensional kodhi, Mutakuri Mutengo uye Zvekuverenga Equipment Mutengo weRFID Tag wakakwira, asi RFID Yekuverenga Yekumhanya Inokurumidza, Inogona Kuwana Batch Kuverenga, uye Inogona Kuita Basa Mune Mamwe Manongedzo Neminda.
Iye Akanyoresa / Rekodha Anogona Kusarudza Iyo Yakakodzera Yakasarudzika Kuzivikanwa Dhata Inotakura Yechishandiso Chekurapa Zvinoenderana Nehunhu, Kukosha, Mamiriro Ekushandisa Makuru uye Zvimwe Zvinhu zveChigadzirwa.
Iye Akanyoresa / Rekodha Anogona Kusarudza Iyo Yakakodzera Yakasarudzika Kuzivikanwa Dhata Inotakura Yechishandiso Chekurapa Zvinoenderana Nehunhu, Kukosha, Mamiriro Ekushandisa Makuru uye Zvimwe Zvinhu zveChigadzirwa.
8, Ndeupi Rudzi Rwekufanirwa runodiwa neCode Issuing Agency, Uye Ndeapi Mabasa Ayo Uye Zvisungo?
Iyo Code Inoburitsa Institution Yeiyo Yakasarudzika Kuzivikanwa Kwechishandiso Chichave Chibvumirano Chemutemo Mukati Yenharaunda yeChina, Iine Yakakwana Management System uye Operation System, Kuti ive nechokwadi chekusiyana kweiyo Yakasarudzika Kuzivikanwa kweChishandiso Chekurapa Yakagadzirwa Mukuenderana neMitemo Yayo, Uye Sangana Nezvinodikanwa Zvinodiwa Zvekuchengetedza Dhata muChina.
Iyo Code Inoburitsa Institution Ichapa Iye Akanyoresa / Rekodhi Mubati Nemaitirwo Ekuita Iyo Standard uye Inotungamira Kuita.Kuti Ufambise Munyoreri / Rekodhi Anobata Kuti Atore Iyo Code Standard yeCode Inoburitsa Institution Kune Mapato Akakodzera Kusarudza kana Kunyorera, Iyo Code Inoburitsa Institution Ichaisa Yayo Code Standard kune Yakasarudzika Identification Dhatabheti Yezvokurapa Zvishandiso Uye Nesimba Kuichengeta.Pamberi paNdira 31 Wegore rega rega, Sangano Rinoburitsa Rinoendesa kuSDA Chirevo Chegore Rapfuura PaKuzivikanwa Kwakasarudzika Yakagadzirwa Zvinoenderana Nemaitiro Ayo.
9, Chii Chiri Maitiro Kune Akanyoresa / Filer Kuti Aite Yakasarudzika Kuzivikanwa?
Iyo Maitirwo Eanonyoresa / Filer Kuti Aite Iyo Yakasarudzika Chiziviso Ndeyokutevera:
Nhanho 1: Iye Akanyoresa / Filer Achasarudza Iyo Code Inoburitsa Institution Zvinoenderana neMitemo uye Hunoenderana Maitiro uye Iyo chaiyo Mamiriro eBhizinesi.
Nhanho yechipiri: Iye Akanyoresa / Anofaya Munhu Anogadzira Iyo Chigadzirwa Chiziviso Zvinoenderana Nemayero Esangano Rinoburitsa Uye Inosarudza Kuumbwa Kwechigadzirwa Kuzivikanwa Kuzivikanwa.
Nhanho 3: Kubva PaZuva Rekuita KweMitemo, Kana Kunyorera Kunyoreswa, Kunyoreswa Shanduko Kana Kufaya Kwemichina Yekurapa, Iye Akanyoresa / Anonyora Munhu Anoendesa Chigadzirwa Chiziviso MuKunyoresa / Kuisa Management System.
Nhanho 4: Iye Akanyoresa / Rekodha Achasarudza Yakakodzera Dhata Inotakura Zvinoenderana neMayero eiyo Coding Institution, Uye Ipe Chishandiso Chekurapa Iyo Yakasarudzika Identification Dhata Inotakura kune Iyo Minimum Sales Unit uye Yepamusoro-Level Packaging Kana Medical Chishandiso Chigadzirwa.
Nhanho yechishanu: Iye Akanyoresa / Rekodha Achaisa Iyo Chigadzirwa Identification uye Ruzivo rwakakodzera kune Yakasarudzika Kuzivikanwa Dhatabhesi Yemidziyo Yekurapa Chigadzirwa Chisati Chaiswa Pamusika.
Nhanho 6: Kana Iyo Chigadzirwa Kuzivikanwa Uye Inoenderana Neruzivo Ruzivo Runochinja, Iye Akanyoresa / Rekodha Achavandudza Iyo Yakasarudzika Kuzivikanwa Dhatabhesi Yemidziyo Yekurapa Nenguva.
Nguva yekutumira: Aug-27-2019
