1, Kodi Chidziwitso Chapadera Cha Zida Zachipatala Ndi Chiyani?
Chizindikiritso Chapadera Cha Zida Zachipatala Chimakhala ndi Kuzindikiritsa Zinthu Ndi Chizindikiritso Chopanga.Chidziwitso Chazogulitsa Ndi Khodi Yapadera Yozindikiritsa Wolembetsa / Filer, Model, Mafotokozedwe Ndi Phukusi La Zida Zachipatala.Ndilo "Mawu Ofunika Kwambiri" Kuti Mupeze Zambiri Zofunikira Zazida Zachipatala Kuchokera Pankhokwe, Ndipo Ndilo Gawo Lofunikira Lachidziwitso Chapadera.Chizindikiritso Chopanga Chimaphatikizapo Chidziwitso Chokhudzana ndi Njira Yopangira, Kuphatikizira Nambala ya Gulu Lazamalonda, Nambala Yachizindikiro Ndi Nthawi Yopanga Ndi Tsiku Lomaliza Ntchito, Ndi zina zotero, Zitha Kugwiritsidwa Ntchito Kuphatikizana Ndi Chizindikiritso Chazinthu Kuti Mukwaniritse Zofunikira Zodziwika Bwino Ndi Kulembetsa Pakuzungulira Ndipo Kugwiritsa Ntchito Zida Zachipatala.
Mfundo Yapadera, Kukhazikika Ndi Scalability.Kusiyanitsa Ndi Mfundo Yoyamba, Maziko Owonetsetsa Kuzindikiritsidwa Kolondola Kwa Zogulitsa, Ndipo Mfundo Yachikulu Yantchito Yachizindikiritso Chapadera.Chifukwa Chakuvuta Kwa Zida Zachipatala, Kuphatikizikako Kudzakhala Kugwirizana Ndi Zofunikira Pakuzindikiritsa Zamalonda.Kwa Zida Zachipatala Zomwe Zili ndi Makhalidwe Omwewo, Kusiyanitsa Kudzalozera ku Chidziwitso Chimodzi Ndi Mtundu Wachitsanzo;Kwa Zamgulu Zoyendetsedwa Ndi Kupanga Kwa Batch, Kuphatikizikako Kudzaloza Pagulu Limodzi Lazinthu;Pazida Zachipatala Zomwe Zimayendetsedwa Ndi Kupanga Nambala Ya Seri, Kuphatikizikako Kudzaloza Pakanthu Imodzi.
Kukhazikika Kumatanthauza Kuti Chidziwitso Chapadera Chikaperekedwa Ku Chida Chachipatala, Malingana Ngati Makhalidwe Ake Oyambirira Sanasinthidwe, Chizindikiritso Chazogulitsa Chiyenera Kukhala Chosasinthika.Pamene Kugulitsa ndi Kugwiritsa Ntchito Zida Zachipatala Kuyimitsidwa, Kuzindikiritsa Kwazinthu Sikuyenera Kugwiritsidwa Ntchito Pazida Zina Zachipatala;Kugulitsa ndi Kugwiritsa Ntchito Kukayambiranso, Chizindikiritso Choyambirira Chikhoza Kugwiritsidwa Ntchito.
Extensibility Imatanthauza Kuti Chizindikiritso Chapadera Chiyenera Kugwirizana ndi Zofunikira Zoyang'anira Ndi Kupititsa patsogolo Ntchito Zogwiritsa Ntchito.Mawu oti "Wapadera" Sakutanthauza Kuti Kuwongolera Nambala Yachingwe Kwachinthu Chimodzi Kumachitika.Mu Chizindikiritso Chapadera, Chizindikiritso Chopanga Chitha Kugwiritsidwa Ntchito Pophatikizana Ndi Chizindikiritso Chazogulitsa Kuti Mukwaniritse Kuphatikizika Kwa Magawo Atatu: Mafotokozedwe, Mtundu, Gulu ndi Chinthu Chimodzi, Kuti Mukwaniritse Zomwe Zaposachedwa Ndi Zamtsogolo Pazida Zachipatala Dziwani Zofunikira.
2, Chifukwa Chiyani Kumanga Dongosolo Lapadera Lozindikiritsa Zida Zachipatala?
Ukadaulo Wazachipatala, Mankhwala Ndi Zida Zachipatala Ndizipilala Zitatu Zadongosolo la Ntchito Zachipatala.Zipangizo Zachipatala Zimaphatikizapo Phokoso, Kuwala, Magetsi, Magnetism, Zithunzi, Zida, Makaniko Ndi Pafupifupi Maluso Aukatswiri A zana limodzi.Ndiwo Makampani Odziwika Padziko Lonse Apamwamba-Chatekinoloje Industries, Ndi Makhalidwe a High-Chatekinoloje kwambiri, Interdisciplinary, Technology Integration ndi Integration, Ndipo akuimira mphamvu zonse za High-Tech dziko.M'zaka zaposachedwa, ndi Kukula Kwachangu kwa Makampani Azipangizo Zamankhwala, Ukadaulo Watsopano Ndi Zogulitsa Zikuwonekera Pamtsinje Wosatha, Ndipo Kusiyanasiyana Kwazinthu Ndi Kusokonekera Zikuyenda Bwino Nthawi Zonse.Palibe Code Kapena Chinthu Chimodzi Chokhala Ndi Ma Code Angapo Pakuzungulira Ndi Kugwiritsa Ntchito Zida Zachipatala, Zomwe Zimakhudza Kwambiri Kuzindikiritsa Zolondola Zazida Zachipatala Pakupanga, Kuzungulira Ndi Kugwiritsa Ntchito Zida Zachipatala, Ndipo Ndikovuta Kukwaniritsa Kuyang'anira Ndi Kasamalidwe Moyenera.
Chizindikiritso Cha Chida Chapadera (UDI) Ndi Khadi la ID la Zida Zachipatala.Dongosolo Lachidziwitso Lapadera Lazida Zachipatala Limakhala Ndi Chizindikiritso Chapadera, Wonyamula Data Ndi Database.Kupatsa Chida Chilichonse Chachipatala Khadi la ID, Kuzindikira Kuwonekera Ndi Kuwoneka Kwa Kupanga, Kugwira Ntchito Ndi Kugwiritsiridwa Ntchito, Ndi Kuwongolera Kutsatiridwa Kwa Zogulitsa Ndiwo Mfungulo Pakukulitsa Njira Zoyang'anira Chipangizo Chachipatala Ndi Kupititsa patsogolo Kuyang'anira Bwino.Idzagwira Ntchito Yabwino Pakutsata Pansi Pansi pa Chitetezo cha Chipangizo Chachipatala Ndikuthandizira Kukula Kwapamwamba Kwambiri Pazida Zachipatala.Chifukwa chake, Kupanga Kwapadera Kwazidziwitso Zazida Zachipatala Ku China Kukufunika Mwachangu.
Chizindikiritso Chapadera cha Zida Zachipatala Ndiko Kuyikira Kwambiri Ndi Malo Otentha M'munda Wamalamulo a Zida Zamankhwala Padziko Lonse.Mu 2013, Bungwe la International Medical Device Regulatory Body Forum (Imdrf) Linapereka Chitsogozo cha Unique Identification System of Medical Devices.M'chaka chomwecho, United States Inapereka Malamulo Pa Njira Yapadera Yozindikiritsa Zida Zachipatala, Zomwe Zimafunika Kukwaniritsidwa Kwathunthu Kwa Njira Yapadera Yozindikiritsa Zida Zachipatala Pasanathe Zaka 7.Mu 2017, Malamulo a EU Anafunikira Kukhazikitsidwa Kwa Chizindikiritso Chapadera Cha Zida Zachipatala.Japan, Australia, Argentina Ndi Mayiko Enanso Agwira Ntchito Yoyenera, Ndipo Chidziwitso Chapadera Chapadziko Lonse cha Zida Zachipatala Chakwezedwa Mosalekeza.
Mu 2012, Bungwe la State Council linapereka ndondomeko ya National Drug Safety Plan ya 12th 5 Year Plan, yomwe inaitanitsa "Kukhazikitsa National Unified Coding Of High-Risk Medical Devices".Mu 2016, Bungwe la State Council linapereka 13th Year Plan for National Drug Safety, yomwe imafuna "Kupanga Medical Device Coding System ndi Kupanga Malamulo a Medical Device Coding".Mu 2019, Ofesi Yaikulu Ya State Council Inapereka Ntchito Zofunika Kwambiri Zokulitsa Kusintha Kwa Zachipatala ndi Zaumoyo Mu 2019, Zomwe Zimafuna "Kupanga Malamulo a Njira Yapadera Yozindikiritsa Zida Zachipatala", Zomwe zidaganiziridwa ndikuvomerezedwa ndi The Msonkhano Wachisanu ndi chitatu wa Central Comprehensive Deepening Reform Committee.Mu "Reform Plan for the treatment of High-Value Medical Consumables" Yoperekedwa ndi General Office of the State Council, Ikupititsa patsogolo "Kupanga Njira Yapadera Yozindikiritsa Zida Zachipatala" Malamulo Ogwirizana ". Mu July 2019, The State Food Ndipo Drug Administration, Pamodzi ndi National Health and Health Commission, Adapereka Mogwirizana Dongosolo Lantchito Yoyendetsa Njira Yozindikiritsa Zazida Zachipatala, zomwe zikuwonetsa kuyambika kwa Ntchito Yopanga Chidziwitso Chapadera cha Zida Zachipatala ku China.
3, Kodi Kufunika Kopanga Chidziwitso Chapadera Kwa Zida Zachipatala Ndi Chiyani?
Kudzera Kukhazikitsa Dongosolo Lapadera Lozindikiritsa Zida Zachipatala, Imathandizira Kuphatikizika Ndi Kugawana Zambiri Zowongoleredwa, Kupanga Kwachitsanzo Choyang'anira, Kupititsa patsogolo Kuchita Bwino Kwaulamuliro, Kulimbitsa Kayendetsedwe ka Moyo Wazida Zachipatala, Kuyeretsa Kwa Zida Zachipatala. Msika, Kukhathamiritsa Kwa Chilengedwe Cha Bizinesi, Kuphatikiza Malamulo A Boma Ndi Ulamuliro Wamakhalidwe, Kupanga Mkhalidwe Wa Ulamuliro Wachikhalidwe, Kukwezeleza Kusintha Kwamafakitale, Kukweza ndi Kutukuka Kwaumoyo, Ndi Kupereka Zina Tidzawonjezera Ntchito Zachipatala Zotetezedwa Ndi Zogwira Ntchito Komanso Kupititsa patsogolo Kufikira Kwa Anthu.
Kuchokera ku Industrial Point of View, Kwa Opanga Zida Zachipatala, Kugwiritsa Ntchito Chizindikiro Chapadera Kumathandiza Kupititsa patsogolo Mulingo Wa Kuwongolera Chidziwitso cha Enterprise, Kukhazikitsa Dongosolo Loyang'anira Zamalonda, Kulimbitsa Kudziletsa Kwa Makampani, Kuwongolera Bwino Lamabizinesi, Ndi Kupititsa patsogolo Ntchito Zapamwamba- Kukula Kwabwino Kwa Makampani Opangira Zida Zamankhwala.Kwa Makampani Abizinesi Yazida Zamankhwala, Kugwiritsa Ntchito Chizindikiritso Chapadera Kutha Kukhazikitsa Dongosolo Lamakono Lakuwongolera, Ndipo Kuzindikira Kuwonekera, Kuwona ndi Luntha la Chipangizo Chothandizira Zamankhwala.Kwa Mabungwe azachipatala, Kugwiritsa Ntchito Chizindikiritso Chapadera Kumathandiza Kuchepetsa Zolakwa Zazida, Kukweza Kasamalidwe Kazinthu Zogula M'chipatala, Ndi Kusunga Chitetezo Cha Odwala.
Kuchokera pa Kawonedwe ka Boma, Poyang'anira Zida Zachipatala, Kugwiritsa Ntchito Chizindikiritso Chapadera Kungathe Kumanga Zambiri Zazikulu Zoyang'anira Zida Zachipatala, Zindikirani Gwero la Zida Zachipatala Zitha Kuyang'aniridwa, Kopita Kukhoza Kutsatiridwa, Udindo Ukhoza Kukhala Kufufuzidwa, Ndi Kuzindikira Kuyang'anira Mwanzeru.Kwa Dipatimenti Yoyang'anira Zaumoyo, Kugwiritsa Ntchito Chizindikiritso Chapadera Kutha Kulimbitsa Kasamalidwe Kokhazikika Kwa Zida Zachipatala, Kulimbikitsa Kukhazikitsidwa Kwazidziwitso Zazidziwitso Zaumoyo, Kupititsa patsogolo Kuchita Bwino Kwa Kasamalidwe Kaumoyo, Ndikuthandizira Njira Yaumoyo ku China.Kwa Dipatimenti ya Inshuwaransi Yachipatala, Imathandiza Kuzindikiritsa Zida Zachipatala Molondola Pakugula Zogula, Kulimbikitsa Kuwonekera Kwa Kukhazikika, Ndi Kulimbana ndi Chinyengo ndi Nkhanza.
Kuchokera pa Mawonedwe a Anthu, Kupyolera mu Kuwulula Chidziwitso ndi Kugawana Zambiri, Ogwiritsa Ntchito Atha Kugwiritsa Ntchito Ndi Kumvetsetsa Kugwiritsa Ntchito Mosavuta, Ndipo Kuteteza Moyenera Ufulu Wovomerezeka Ndi Zokonda Za Ogwiritsa Ntchito.
4, Mfundo Zotani Zokhudza Kukhazikitsa Kwapadera Kuzindikiritsa Zida Zachipatala?
Malamulo a Dongosolo Lapadera Lozindikiritsa Zida Zachipatala (Zomwe Zatchulidwa Pano Monga Malamulo) Amafuna Kuti Kupanga Kwadongosolo Lapadera Lachizindikiritso Kuyenera Kuphunzira Mwachangu Kuchokera ku Miyezo Yapadziko Lonse Ndikutsatira Mfundo Zazitsogozo Zaboma, Kukhazikitsa Mabizinesi, Kukwezeleza Pazonse Ndi Kukhazikitsa Kugawa.Pofuna Kukweza Bwino Kusinthanitsa ndi Malonda Padziko Lonse, Ndi Kukulitsa Chilengedwe Cha Bizinesi, Kumanga kwa Chidziwitso Chapadera cha China Kumatengera Maphunziro ku Mfundo ndi Miyezo Yovomerezeka Padziko Lonse.Khazikitsani Dongosolo Lapadera Lachizindikiritso, Boma Limachita Udindo Wotsogola, Wolembetsa / Wojambulira Monga Munthu Woyamba Woyang'anira Ali Ndi Udindo Wokhazikitsa, Ndikugwiritsa Ntchito Chizindikiritso Chapadera Kuti Atukule Ubwino Wazinthu Ndi Kasamalidwe Kabizinesi.Chifukwa Chakusiyanasiyana Ndi Kuvuta Kwa Zida Zachipatala, Kukhazikitsidwa Kwa Chizindikiritso Chapadera Gawo Ndi Gawo Ndi Mchitidwe Wovomerezeka Padziko Lonse.Zida Zachipatala zaku China Zimayendetsedwa Molingana ndi Mulingo Wowopsa.Kutengera Zomwe Zachitika Pakuzindikiritsa Kwapadera Kwapadziko Lonse, Kuphatikizidwa ndi Mkhalidwe Weniweni Wamakampani a Zida Zachipatala ku China Ndi Kuyang'anira, Ndondomeko Yoyendetsera Gawo Ndi M'njira Imapangidwa.Poyerekeza ndi United States ndi Europe, Kukhazikitsidwa Kwa Chizindikiritso Chapadera Ku China Kwachulukitsa Ulalo Woyendetsa, Makamaka Zida Zachipatala Zomwe Zili Ndi Chiwopsezo Chambiri, Zokhala Ndi Zochepa Zing'onozing'ono, Kuonetsetsa Kuti Malamulowa Akuyenda Mokhazikika.
5, Momwe Mungadziwire Kuphatikizika Ndi Kugawana Kwa Chidziwitso Chapadera?
Kutoleredwa Kwa Deta Ndi Kugawana Kwa Chidziwitso Chapadera Cha Zida Zachipatala Zimazindikirika Kupyolera mu Chidziwitso Chapadera cha Zida Zachipatala, Zomwe Zimakonzedwa Ndi Kupangidwa Ndi State Drug Administration.Wolembetsa / Wojambulira Amakweza Chidziwitso Chazogulitsa Ndi Zambiri Zofananira Zachizindikiritso Chapadera Kumalo Osungirako Molingana ndi Miyezo Yoyenera Ndi Zomwe Zafotokozedwa, Ndipo Ali Ndi Udindo Wolondola Ndi Kusiyana Kwa Deta.Mabizinesi a Zida Zamankhwala, Mabungwe azachipatala, Madipatimenti Aboma Oyenera Ndipo Anthu Atha Kugawana Zambiri Zozindikiritsa Zapadera Kupyolera mu Kufunsa Kwa Data, Kutsitsa, Kuyika Deta ndi Njira Zina.
6, Kodi Zomwe Zatchulidwazi Zisanakhazikitsidwe Malamulo Ayenera Kupatsidwa Chizindikiritso Chapadera?
Kuyambira Patsiku Lokhazikitsa Malamulowo, Wolembetsa / Wolemba Fayilo Adzapereka Chidziwitso Chake Pakaundula / Kusunga Kasamalidwe ka Maofesi Akamafunsira Kulembetsa, Kusintha Kulembetsa Kapena Kusunga Zida Zachipatala Zoyenera.Zida Zofunikira Zachipatala Zidzapatsidwa Chizindikiritso Chapadera Panthawi Yopanga, Ndipo Kukweza Kwa Chidziwitso Chapadera Chozindikiritsa Chidziwitso Chachidziwitso Ndi Chidziwitso Choyenera cha Chipangizo Chachipatala Chidzamalizidwa Zogulitsa Zisanayikidwe Pamsika.
Zida Zachipatala Zomwe Zapangidwa Ndi Kugulitsidwa Tsiku Lisanafike Lakukhazikitsa Malamulowo Sizingakhale Ndi Chidziwitso Chapadera Cha Zida Zachipatala.
7, Momwe Mungasankhire Chonyamula Chidziwitso Chapadera cha Zida Zachipatala?
Pakali pano, Onyamula Data Pamsika Amaphatikizapo Khodi ya Dimensional Code, Two-Dimensional Code ndi Radio Frequency Tag (RFID).
Khodi Ya Dimensional Imodzi Ndi Chizindikiro Cha Bar Code Chomwe Chimangoyimira Chidziwitso Mumayendedwe Amodzi.Yakhala Ikugwiritsidwa Ntchito Kwa Zaka Zambiri Ndipo Ili ndi Mtengo Wotsika.Itha Kukhala Yogwirizana Ndi Zida Zomwe Zilipo Pamsika, Koma Njira Yanjira Imodzi Imakhala Ndi Malo Aakulu Ndipo Imatha Kuwonongeka Kowonongeka.
Awiri Dimensional Code Ndi Bar Code Chizindikiro Choyimira Chidziwitso Mumayendedwe Awiri.Poyerekeza ndi Khodi ya Dimensional Imodzi, Malo Omwewo Atha Kukhala ndi Zambiri, Zomwe Zitha Kuchita Bwino Pamene Kukula Kwapachipangizo Kwachipangizo Ndikochepa.Ili ndi Mphamvu Zina Zowongolera Zolakwika, Koma Zofunikira Pazida Zowerengera Ndi Zapamwamba Kuposa Khodi Ya Dimensional Imodzi.
RFID Tag Ili Ndi Ntchito Yosungira Zidziwitso, Yomwe Imatha Kulandila Chizindikiro cha Electromagnetic Modulation of the Reader ndikubwerera kwa Wonyamula Data wa Signal Yogwirizana.Poyerekeza ndi Khodi ya Dimensional Imodzi Ndi Khodi ya Dimensional, Mtengo Wonyamula ndi Zida Zowerengera Mtengo wa RFID Tag Ndiwokwera, Koma Kuthamanga kwa RFID Kumathamanga, Kumatha Kuwerenga Batch, Ndipo Imatha Kuchita Nawo Malumikizidwe Ena Ndi Minda.
Wolembetsa / Wojambulira Atha Kusankha Wonyamula Chidziwitso Chapadera Chazida Zachipatala Molingana ndi Makhalidwe, Mtengo, Zochitika Zazikulu Zogwiritsira Ntchito Ndi Zina Zazogulitsa.
Wolembetsa / Wojambulira Atha Kusankha Wonyamula Chidziwitso Chapadera Chazida Zachipatala Molingana ndi Makhalidwe, Mtengo, Zochitika Zazikulu Zogwiritsira Ntchito Ndi Zina Zazogulitsa.
8, Ndi Chiyeneretso Chotani Chimene Bungwe Lopereka Ma Code Limafunikira, Ndipo Udindo Wake Ndi Zofunika Zotani?
The Code Issuing Institution of the Unique Identification of the Chipangizo Lidzakhala Bungwe Lalamulo M'chigawo cha China, Ndi Njira Yabwino Yoyang'anira Ndi Njira Yogwirira Ntchito, Kuonetsetsa Kuphatikizika Kwa Chidziwitso Chapadera Cha Chipangizo Chachipatala Chopangidwa Mogwirizana ndi Miyezo Yake, Ndipo kwaniritsani Zofunikira Zachitetezo cha Data ku China.
Bungwe Lopereka Ma Code Lidzapereka Wolembetsa / Wosunga Zolemba Ndi Njira Yoyendetsera Mulingo Ndi Kuwongolera Kukhazikitsidwa.Kuti Mutsogolere Wolembetsa / Wosunga Zolemba Kuti Adziwe The Code Standard Of The Code Issuing Institution Kwa Maphwando Oyenera Kusankha Kapena Kuyika, The Code Issuing Institution Idzakweza Code Yake Yokhazikika ku Database Yapadera Yazidziwitso Zazida Zachipatala Ndi Kuzisunga Mwamphamvu.Pasanafike pa Januware 31 Chaka chilichonse, Bungwe Lotulutsa Lidzapereka Lipoti la Chaka Cham'mbuyo ku SDA Pa Chizindikiritso Chapadera Chopangidwa Mogwirizana ndi Miyezo Yake.
9, Kodi Njira Yoti Wolembetsa / Wofayira Akwaniritse Chidziwitso Chapadera Ndi Chiyani?
Njira Yoti Wolembetsa / Fayilo Akwaniritse Chizindikiritso Chapadera Ndi Motere:
Khwerero 1: Wolembetsa / Wolemba Fayilo Adzasankha Bungwe Lopereka Khodi Molingana ndi Malamulo Ndi Miyezo Yoyenera Ndi Mkhalidwe Weniweni wa Bizinesi.
Khwerero 2: Munthu Wolembetsa / Wolemba Mafayilo Amapanga Chidziwitso Chogulitsa Molingana ndi Miyezo ya Bungwe Lopereka Ndipo Amasankha Mapangidwe A Chidziwitso Chopanga Zinthu.
Khwerero 3: Kuyambira Patsiku Lokhazikitsa Malamulowo, Ngati Mukufunsira Kulembetsa, Kusintha Kulembetsa Kapena Kusunga Zida Zachipatala, Munthu Wolembetsa / Wosungitsa Adzapereka Chidziwitso Chake Muzolembetsa / Kusunga Kasamalidwe ka Maofesi.
Khwerero 4: Wolembetsa / Wojambulira Adzasankha Wonyamula Deta Yoyenera Molingana ndi Miyezo ya Coding Institution, Ndikupatsa Chipangizo Chachipatala Chidziwitso Chapadera Chonyamulira Zambiri Kugawo Lochepera Logulitsa Ndi Kupaka Kwapamwamba Kwambiri Kapena Zida Zachipatala.
Khwerero 5: Wolembetsa / Wojambulira Adzakweza Chizindikiritso Chazinthu Ndi Zambiri Zoyenera Kuzidziwitso Zapadera Zazida Zachipatala Zogulitsa Zisanayikidwe Pamsika.
Khwerero 6: Chidziwitso Chachidziwitso Ndi Chidziwitso Chokhudzana ndi Zambiri Zikasintha, Wolembetsa / Wojambulira Adzasinthanso Chidziwitso Chapadera Chazida Zachipatala Panthawi.
Nthawi yotumiza: Aug-27-2019
