Ngomhla zizi-4 kuJulayi, 2019, i-Antarctic Bear Discovery, i-National Food and Drug Administration kanye neKhomishana Kazwelonke Yezempilo Nezempilo bakhiphe "Isimemezelo Semithetho Yokuqondisa Nokuphatha Yamadivayisi Ezokwelapha Angokwezifiso (Isivivinyo) (2019 No. 53)".

Umuntu ophrinta i-3D yezokwelapha wabubula, "Ucingo luyaphuma! Kusukela ngomhla ka-28 Novemba 2016 ukuya ku-State Food and Drug Administration okokuqala ngqa ukubamba iqhaza kusemina yezokwelapha eyenziwe ngokwezifiso kuze kube namuhla, sekuphele izinsuku ezingama-948, izinwele zami seziphelele. NS emhlophe!"

Ngempela, lesi isenzakalo esihle emkhakheni wokuphrinta we-3D wezokwelapha waseChina! Izicubu nezitho ezithile zesiguli ngasinye zihlukile. Imishini yezokwelapha yendabuko ngokuvamile ilinganiswe ngokuma nangosayizi, engakwazi ukuhlangabezana nezidingo zesiguli ngasinye; kuyilapho ukuphrinta kwe-3D kunganikeza ukukhiqizwa kwedivayisi okusheshayo futhi okungabizi kakhulu. , Ifaneleka kakhulu isicelo ekwenzeni ngokwezifiso zezokwelapha. Izidingo ezibanzi neziqinile zingenza imishini yezokwelapha eyenziwe ngokwezifiso ye-3D isebenze ukuze kuzuze abantu baseShayina. Kodwa-ke, ngenxa yokuntuleka kwemithetho nemithethonqubo efanelekile ngaphambili, ukusetshenziswa kokuphrinta kwe-3D yezokwelapha kuqhubeke kancane. Ukufakelwa kokuqala okuphrintiwe kwensimbi kwe-3D okuvunyelwe eShayina kuphinde kwavunyelwa yilayisensi yokubhalisa ye-CFDA Class III kuphela ngesinqumo sabaholi abamaphakathi.

"Imithethonqubo Yokuqondisa Nokuphathwa Kwamadivayisi Ezokwelapha Angokwezifiso (Isivivinyo)" ikhishwe ngokusemthethweni

Ukuze kuhlangatshezwane nezidingo ezingavamile nezikhethekile eziqondene nomuntu ekusebenzeni komtholampilo, qinisa ukugadwa nokuphathwa kwemishini yezokwelapha eyenziwe ngokwezifiso, futhi uqinisekise ukuphepha nokusebenza kahle kwemishini yezokwelapha eyenziwe ngokwezifiso, i-State Food and Drug Administration kanye neKhomishini Yezempilo Kazwelonke ikhiphe ngokuhlanganyela " Mayelana Nokukhishwa (ngemuva kwalokhu okubizwa ngokuthi “Imithethonqubo”) izosetshenziswa ngokusemthethweni ngoJanuwari 1, 2020.

"Imithethonqubo" ihlukaniswe yaba izahluko eziyisithupha, okuhlanganisa izinhlinzeko ezijwayelekile, ukuphathwa kwamafayela, ukuklama nokucubungula, ukuphathwa kokusetshenziswa, ukugada nokuphatha, nezinhlinzeko ezengeziwe, okuhlanganisa izihloko ezingama-35, ezicacisa incazelo, ukufakwa, ukuklama, ukucubungula, ukusetshenziswa, ukugada. kanye nokuphathwa kwemishini yezokwelapha eyenziwe ngokwezifiso. . Imishini yezokwelapha eyenziwe ngokwezifiso iklanywa futhi ikhiqizwa abakhiqizi bemishini yezokwelapha ngokusekelwe ezidingweni ezikhethekile zomtholampilo zezikhungo zezokwelapha ukuze kuhlangatshezwane nezimo zezifo ezingavamile nezikhethekile zeziguli eziqokiwe. Imishini yezokwelapha yomuntu siqu yesiguli okulindeleke ukuba ithuthukise ukusebenza kokuxilongwa nokwelashwa. Uma kucatshangelwa ukuthi imishini yezokwelapha eyenziwe ngokwezifiso isetshenziselwa iziguli ezithile kuphela, inombolo incane kakhulu, futhi kunzima ukubhalisa ngemodeli yokuphatha ukubhaliswa kwamanje. "Izimiso" zisebenzisa ngokusobala ukuphathwa kokufakwa kwefayela kwemishini yezokwelapha eyenziwe ngokwezifiso, futhi abakhiqizi bemishini yezokwelapha abangokwezifiso kanye nezikhungo zezokwelapha zizosebenza ngokuhlanganyela njengabantu abafaka izicelo. Ukuze kulawulwe ubungozi ngendlela ephusile, "Imithetho" ibeka phambili izimfuneko ezicacile zabakhiqizi nezikhungo zezokwelapha ezikhiqiza futhi zisebenzise imishini yezokwelapha eyenziwe ngokwezifiso, futhi kusobala ukuthi imishini yezokwelapha eyenziwe ngokwezifiso ngeke ithunyelwe ukuthi ikhiqizwe.

"Imithetho" iphinda icacise ukuthi uma inani lezimo zokusetshenziswa komtholampilo kanye nezifundo zokuqala zemishini yezokwelapha eyenziwe ngokwezifiso zingahlangabezana nezimfuneko zokugunyazwa kusengaphambili kwemakethe, kufanele bafake isicelo sokubhaliswa noma ukufakwa kwefayela ngokuvumelana "Nezinyathelo Zokulawula Ukubhaliswa Kwedivayisi Yezokwelapha" kanye "Nezinyathelo Zokulawula Ukubhaliswa Kwe-In Vitro Diagnostic Reagent". . Idatha yokusetshenziswa komtholampilo evumelana nezindinganiso zokuziphatha futhi iyiqiniso, inembile, iphelele, futhi iyalandeleka ingasetshenziswa njengedatha yokuhlolwa komtholampilo yezicelo zokubhalisa.

Ukukhishwa kanye nokuqaliswa kwe "Regulations" kuzophinde kukhuthaze ucwaningo olusha kanye nokuthuthukiswa kwemishini yezokwelapha eyenziwe ngokwezifiso, imise futhi ikhuthaze ukuthuthukiswa okunempilo kwemboni, ukuhlangabezana nezidingo ezingavamile nezikhethekile zomtholampilo, futhi uqinisekise ngempumelelo ukuphepha komtholampilo. ukusetshenziswa komphakathi kwezinto zokusebenza.

Ukuhunyushwa "Kwemithethonqubo Yokugadwa Nokuphathwa Kwamadivayisi Ezokwelapha Angokwezifiso (Isivivinyo)"

1. Mayelana nencazelo. Imishini yezokwelapha yomuntu siqu ibhekisela kumathuluzi ezokwelapha aklanywe futhi akhiqizwa abakhiqizi bemishini yezokwelapha ngokusekelwe ezidingweni zomtholampilo zabasebenzi bezokwelapha abagunyaziwe bezikhungo zezokwelapha ukuze bahlangabezane nezimfuneko eziqondene nawe zeziguli. Ahlukaniswe abe yimishini yezokwelapha eyenziwe ngokwezifiso kanye nemishini yezokwelapha efaniswa nesiguli.

Imishini yezokwelapha eyenziwe ngokwezifiso iklanywa futhi ikhiqizwa abakhiqizi bemishini yezokwelapha ngokusekelwe ezidingweni ezikhethekile zomtholampilo zezikhungo zezokwelapha ukuze kuhlangatshezwane nezimo zezifo ezingavamile nezikhethekile zeziguli eziqokiwe. Lapho imikhiqizo esemakethe ezweni lami inzima ukuhlangabezana nezidingo zomtholampilo, iklanywa futhi ikhiqizwe abakhiqizi bemishini yezokwelapha ezigulini eziqokiwe. Imishini yezokwelapha eyenzelwe wena uqobo okulindeleke ukuthi ithuthukise ukusebenza kokuxilongwa nokwelashwa. Ngakho-ke, imishini yezokwelapha eyenziwe ngokwezifiso inezici ezilandelayo: Okokuqala, isetshenziselwa ukuxilongwa nokwelashwa kwezilonda ezingavamile nezikhethekile, futhi inani elilindelekile labasebenzisi lincane kakhulu, futhi awekho amasampula esibalo esanele sokwenza ukuhlolwa kwemitholampilo; Okwesibili, imikhiqizo esemakethe ezweni lami inzima ukuhlangabezana nezidingo zomtholampilo; Okwesithathu, Kuhlongozwa odokotela ukuba baklame futhi bakhiqize ukuze bahlangabezane nezidingo ezikhethekile zomtholampilo; okwesine, isetshenziselwa isiguli esithile futhi kulindeleke ukuthi ithuthukise ukuxilongwa kanye nomphumela wokwelapha.

Imishini yezokwelapha efaniswa nesiguli ibhekisela emishinini yezokwelapha yomuntu siqu eklanywe futhi ekhiqizwa abakhiqizi bemishini yezokwelapha ngokusekelwe ekukhiqizeni ngobuningi kwemikhiqizo yemishini yezokwelapha ngokuvumelana nezicaciso ezijwayelekile futhi ngokusekelwe ezidingweni zomtholampilo ngokuhambisana nenqubo eqinisekisiwe. Imishini yezokwelapha efaniswe nesiguli inalezi zimpawu ezilandelayo: Okokuqala, iklanywa futhi yakhiqizwa ngesisekelo sokukhiqizwa ngobuningi bemikhiqizo yensiza yezokwelapha ngokuya ngemininingwane evamile futhi ifaniswe nezici zomuntu ngamunye zeziguli, ezingathathwa njengezicaciso ezithile namamodeli. kwemikhiqizo esezingeni; okwesibili, ukuklama nokukhiqizwa kwazo kufanele kugcinwe Ngaphakathi kobubanzi bokuqinisekisa nokuqinisekiswa; eyesithathu ingeyesiguli esingase sisetshenziselwe ucwaningo lomtholampilo. Njengamazinyo okufakelwa enziwe ngokwezifiso, amalensi okuxhumana aqinile angakwazi ukungena emoyeni e-orthokeratology, iziqondiso zokuhlinza amathambo, njll. Imishini yezokwelapha efaniswa nesiguli kufanele ibhaliswe noma ifayilishwe ngokuvumelana "Nezinyathelo Zokulawula Zokubhaliswa Kwamadivayisi Ezokwelapha" kanye "Nezinyathelo Zokuphatha Ze- Ukubhaliswa Kwama-In Vitro Diagnostic Reagents", kanye nokucaciswa komkhiqizo namamodeli okubhaliswa/ukubhaliswa kuzoba yibanga labo bonke osayizi abangaba khona bokukhiqiza.

2. Mayelana nezindlela zokuqondisa. Ngokucabangela izici zemikhiqizo, kunzima ukuthi imishini yezokwelapha eyenziwe ngokwezifiso ibhaliswe ngemodeli yokuphatha ukubhaliswa kwamanje. Ngakho-ke, ukuphathwa kokufakwa kwe-pre-market kwenziwa kumadivayisi ezokwelapha angokwezifiso. Amabhizinisi angokwezifiso akhiqiza imishini yezokwelapha kanye nezikhungo zezokwelapha ngokuhlanganyela zisebenza njengamarekhodi. Ngaphambi kokukhiqiza nokusebenzisa amathuluzi ezokwelapha angokwezifiso, kufanele bagcwalise isiphathimandla esilawula izidakamizwa sesifundazwe, isifunda esizimele, kanye nomasipala lapho inkampani ekhiqiza izinto zezokwelapha ikhona (umkhiqizo ongenisiwe yilapho i-ejenti ikhona). Ngokombono wokulawula ubungozi, izisetshenziswa zezokwelapha ezenziwe ngokwezifiso ngeke zithunyelwe ukuthi zikhiqizwe, futhi umuntu ofake isicelo uzoba nezimo ezihambisanayo. Uma umkhiqizi wedivayisi yezokwelapha eyenziwe ngokwezifiso bengenalo uhlobo olufanayo lwesitifiketi sokubhaliswa esivumelekile noma ilayisensi yokukhiqiza yemikhiqizo yedivayisi yezokwelapha ekhiqizwe ngobuningi ngokuya ngokucaciswa okujwayelekile, noma izinto zokusetshenziswa eziyinhloko, izimiso zobuchwepheshe, ukwakheka kwesakhiwo, izinkomba zokusebenza ezibalulekile kanye nobubanzi bohlelo lokusebenza. ziyafana Uma umkhiqizo ugunyazelwe ukubhaliswa, ukufakwa kwefayela kuzoba okungavumelekile ngokuzenzakalela. Umuntu ofaka isicelo uzothatha isinyathelo sokukhansela ukufakwa kwefayela.

Ukuthuthukiswa nokukhiqizwa kwemishini yezokwelapha eyenziwe ngokwezifiso ngeke nje ihlangabezane nezimfuneko zokucaciswa kwekhwalithi yokukhiqiza idivayisi yezokwelapha kanye nezithasiselo ezihlobene, kodwa futhi kuhlangabezane nezimfuneko ezikhethekile, okuhlanganisa nezimfuneko zabasebenzi bokusebenzelana kwezokwelapha nezimboni, ukuklama nokuthuthukiswa, ukulawulwa kwekhwalithi nokuphathwa kokulandeleka.

Ilebula yeziqondiso zedivayisi yezokwelapha eyenziwe ngokwezifiso kufanele ibonise izici zokwenza ngokwezifiso futhi ingalandelelwa esigulini esithile. Ukuze kuqiniswe ukugadwa kwangemva kokumakethwa, ukukhiqizwa nokusetshenziswa kwemishini yezokwelapha eyenziwe ngokwezifiso isebenzisa uhlelo lokubika lonyaka; izidingo ezihambisanayo nazo zibekwe phambili ukuze kusetshenziswe amathuluzi ezokwelapha angokwezifiso, ukukhangisa, kanye nokuvikelwa kolwazi lwesiguli.

Lapho inani lezimo zokusetshenziswa emtholampilo kanye nocwaningo lokuqala lwemishini yezokwelapha eyenziwe ngendlela oyifisayo ingahlangabezana nezimfuneko zokugunyazwa kusengaphambili kwemakethe, amabhizinisi afanele akhiqizayo azofaka isicelo sokubhaliswa noma ukugcwaliswa kwefayela ngokuvumelana "Nezinyathelo Zokulawula Zokubhaliswa Kwedivayisi Yezokwelapha" kanye "Nezokuphatha". Izinyathelo Zokubhaliswa Kwe-In Vitro Diagnostic Reagents". Idatha yokusetshenziswa komtholampilo evumelana nezindinganiso zokuziphatha futhi iyiqiniso, inembile, iphelele, futhi iyalandeleka ingasetshenziswa njengedatha yokuhlolwa komtholampilo yezicelo zokubhalisa. Isibonelo, umzimba wensimbi ophrintiwe we-3D wangokwezifiso wokuhlanganiswa komlomo wesibeletho ungabhaliswa njengedivayisi yezokwelapha efaniswa nesiguli ngemva kwenombolo ethile yezinhlelo zokusebenza zomtholampilo kanye nomklamo oyisisekelo womkhiqizo.

3. Izimo ezingasebenzi. Imishini yezokwelapha efaniswa nesiguli, izinto zezokwelapha ezithobelana nezinhlinzeko ezifanele "Zenqubo Yokuvunyelwa Kwesimo Esiphuthumayo Sedivayisi", kanye nemishini yezokwelapha eyenziwe ngokwezifiso equkethe izithako zokwenza imithi noma izithako ezisebenza ngebhayoloji njengamaseli nezicubu azisebenzi kule Mithetho.

"I-3D Printing Medical Device Kick-off Meeting" obubanjelwe e-Shanghai kusukela ngoJulayi 20 kuya ku-21, 2019. Uhlu oluqine kakhulu lochwepheshe emkhakheni wokuphrinta i-3D yezokwelapha lenze umbiko: I-Academician Lu Bingheng, Academician Dai Kerong, Academician Wang Yingjun, Unobhala u-Shen Guofang weSibhedlela Sesishiyagalolunye sase-Shanghai, iPhini likaMongameli u-Tan Jun weSibhedlela sase-Dongfang, uMqondisi u-Liu Bin weSikhungo Sokuhlola Ubuchwepheshe Bemishini Yezokwelapha se-National Medical Products Administration, uSolwazi wase-Shanghai u-Wang Chengtao wase-Jiaotong University, uSolwazi Ai Songtao we-Shanghai Ninth Hospital, Wang Yiping, uMqondisi we-Yingwei Medical Technology, uSolwazi Liu Zhongjun weSibhedlela Sesithathu saseBeijing, uSolwazi Guo Zheng waseSibhedlela iXijing, Umcwaningi uHan Qianqian we-China Inspection Institute of State Drug Administration, uSolwazi Shen Guofang we-Shanghai Ninth Hospital, Uzokwenza umbiko okhethekile. ekuphrinteni kwe-3D yezokwelapha.

Intatheli ikholelwa ukuthi ukukhishwa kwalo mthethonqubo kuzothuthukisa kakhulu ukuthuthukiswa kwemboni yokunyathelisa yezokwelapha yaseChina ye-3D, ikakhulukazi ukukhiqizwa okwenziwe ngokwezifiso kokunyathelisa kwe-3D emikhakheni yensimbi (njenge-titanium alloy) kanye ne-non-metal (njenge-PEEK), okuyinto izoqhubeka nokugunyazwa esikhathini esizayo Kamuva kuzokwazi ukukhiqiza izicelo ezinkulu.

Xhumanisa nale ndatshana: Intwasahlobo yokuphrinta kwe-3D yezokwelapha isifikile!

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