Pa Seputembara 4, 2017, Boma la State Food and Drug Administration (lomwe tsopano likutchedwa “General Administration”) lidachita msonkhano wa atolankhani kuti litulutse mwalamulo “Classification Catalog for Medical Devices” (yomwe yatchedwa New “Classification Catalogue” yosinthidwa kumene. ”).Kuyambira pa Ogasiti 1, 2018.
Kasamalidwe ka kasamalidwe ka zida zamankhwala ndi njira yovomerezeka padziko lonse lapansi, ndipo gulu lasayansi komanso lololera la zida zamankhwala ndi maziko ofunikira kuyang'anira ntchito yonse yolembetsa, kupanga, kugwira ntchito ndi kugwiritsa ntchito zida zachipatala.
Pakadali pano, pali ziphaso zolembetsa za zida zachipatala pafupifupi 77,000 komanso ziphaso zopitilira 37,000 zolembetsa zida zachipatala ku China.Ndi chitukuko chofulumira cha mafakitale a zida zachipatala komanso kutuluka kosalekeza kwa matekinoloje atsopano ndi zinthu zatsopano, dongosolo lamagulu la zida zachipatala silinathe kukwaniritsa zofunikira za chitukuko cha mafakitale ndi ntchito yolamulira.Buku la 2002 la "Medical Device Classification Catalog" (lomwe limadziwika kuti "Classification Catalog" yoyambirira) Zofooka zamakampani zakhala zikudziwika kwambiri: Choyamba, "Classification Catalog" yoyambirira sinafotokozedwe mokwanira, ndipo dongosolo lonse ndi mlingo mlingo sangathe kukumana panopa makampani ndi malamulo zofunika.Chachiwiri, "Catalogue" yoyambirira inalibe chidziwitso chofunikira monga kufotokozera kwazinthu ndi zomwe akufuna kugwiritsa ntchito, zomwe zidakhudza kufanana ndi kukhazikika kwa chilolezo cholembetsa.Chachitatu, "Category Catalog" yoyambirira inali yovuta kuphimba zatsopano ndi magulu atsopano.Chifukwa chosowa njira yosinthira, zomwe zili m'kabukhuli sizinasinthidwe munthawi yake, ndipo kugawa kwamagulu sikunali koyenera.
Pofuna kukhazikitsa "Regulations on the Supervision and Administration of Medical Devices" yomwe yasinthidwa ndikulengezedwa ndi State Council ndi "Maganizo a State Council on Reforming the Review and Approval System for Drug and Medical Devices", State Food and Drug Oyang'anira afotokozera mwachidule ndi kusanthula zida zamankhwala zomwe zaperekedwa kwazaka zambiri molingana ndi kasamalidwe ka kasamalidwe ka zida zachipatala.Mafayilo amtundu wa zida ndi matanthauzidwe, kukonza zidziwitso zazinthu zovomerezeka zolembetsa zida zachipatala, ndikufufuza kasamalidwe ka zida zachipatala zofananira zakunja.Ntchito yokonzansoyi idakhazikitsidwa mu Julayi 2015, ndipo kukhathamiritsa ndi kusintha kwa chimango, kapangidwe kake ndi zomwe zili mu "Classification Catalog" zidachitika.Anakhazikitsa Medical Device Classification Technical Committee ndi gulu lake akatswiri, anasonyeza mwadongosolo sayansi ndi zomveka zomwe zili mu "Classification Catalog", ndi kukonzanso latsopano "Classification Catalog".
"Category Catalog" yatsopano imagawidwa m'magulu ang'onoang'ono a 22 malinga ndi mawonekedwe aukadaulo wa zida zamankhwala komanso kugwiritsa ntchito kuchipatala.Magawo ang'onoang'ono amapangidwa ndi magulu azinthu zoyambira, magawo achiwiri, mafotokozedwe azinthu, momwe angagwiritsire ntchito, zitsanzo za mayina azinthu, ndi magulu oyang'anira.Posankha gulu lazogulitsa, kutsimikiza kwatsatanetsatane kuyenera kupangidwa kutengera momwe zinthu zilili, kuphatikizidwa ndi kufotokozera kwazinthu, zomwe akufuna kugwiritsa ntchito komanso zitsanzo za mayina azinthu mu "Classification Catalog" yatsopano.Zomwe zili mu "Classification Catalog" yatsopano ndi izi: Choyamba, mapangidwe ake ndi asayansi komanso ogwirizana ndi zochitika zachipatala.Kujambula maphunziro kuchokera kumagulu okhudzana ndi kagwiritsidwe ntchito kachipatala ku United States, ponena za kapangidwe ka "Framework Catalog for Notified Bodies of the European Union", magawo 43 a "Classification Catalogue" yapano aphatikizidwa kukhala 22. magulu ang'onoang'ono, ndi magulu 260 azinthu adayengedwa ndikusinthidwa kukhala magulu 206 amtundu woyamba ndipo magulu 1157 amtundu wachiwiri amapanga mndandanda wamagulu atatu.Chachiwiri, kuphimba ndi kwakukulu, kophunzitsa komanso kugwira ntchito.Zogulitsa zatsopano za 2,000 zawonjezeredwa kuti zigwiritsidwe ntchito ndi mafotokozedwe azinthu zomwe zikuyembekezeredwa, ndipo "Classification Catalog" yamakono yawonjezeredwa ku zitsanzo za 6,609 za mayina a 1008.Chachitatu ndikusintha mwanzeru magulu a kasamalidwe kazinthu, kuwongolera momwe zinthu ziliri m'makampani komanso kuyang'anira kwenikweni, ndikupereka maziko owongolera kugawika kwazinthu zoyang'anira.Malinga ndi kuchuluka kwa chiwopsezo chazinthu komanso kuyang'anira kwenikweni, gulu la kasamalidwe ka zida zachipatala 40 zokhala ndi nthawi yayitali kuti zigulitse, kukhwima kwazinthu komanso zoopsa zomwe zimatha kuwongolera zimachepetsedwa.
Ndondomeko ndi zomwe zili mu "Classification Catalog" zatsopano zasinthidwa kwambiri, zomwe zidzakhudza mbali zonse za kulembetsa zipangizo zachipatala, kupanga, kugwira ntchito, ndi kugwiritsa ntchito.Pofuna kuwonetsetsa kuti maphwando onse amvetsetsana, kusintha kwabwino, ndikukhazikitsa mwadongosolo, State Food and Drug Administration nthawi yomweyo idapereka ndikukhazikitsa "Chidziwitso pa Kukwaniritsidwa kwa Zosinthidwa Zatsopano.”, kupereka pafupifupi chaka chimodzi chokhazikitsa nthawi yosinthira.Kuwongolera maulamuliro ndi mabizinesi okhudzana nawo kuti akwaniritse.Ponena za kasamalidwe ka kaundula, kuganizira mozama momwe makampani a zida zamankhwala alili, kutengera njira yosinthira zachilengedwe kuti agwiritse ntchito "Classification Catalog" yatsopano;kuyang'anira pambuyo pa malonda, kupanga ndi kuyang'anira ntchito kungathe kutengera machitidwe atsopano ndi akale a magulu a zolemba mofanana.Boma la State Food and Drug Administration likonza maphunziro amtundu uliwonse pa "Classification Catalog" yatsopano ndikuwongolera oyang'anira am'deralo ndi makampani opanga kuti akhazikitse "Classification Catalog" yatsopano.
Katundu watsopano wa zida zamankhwala wa 2018 Gwero la zinthu: China Food and Drug Administration, http://www.sda.gov.cn/WS01/CL0051/177088.html
Nthawi yotumiza: Mar-02-2021