Phakathi kochungechunge lwemisebenzi Yeviki Lokusungula Kwedivayisi Yezokwelapha, Iforamu Yokukhiqiza Okuhlakaniphile Nokulawulwa Okukhaliphile Kwamadivayisi Ezokwelapha yayibanjwe ngoSepthemba 11 eSuzhou.Lesi sithangami sasungula Igatsha Lokuqondisa Okuhlakaniphile Kwezokukhiqiza Nokuhlakanipha le-China Medical Device Industry Association, futhi sahlonishwa ngokumema ochwepheshe abaphezulu abayi-7 ukuze babelane ngamathrendi akamuva kanye nobuchwepheshe bokukhiqiza ngobuhlakani kanye nendlela yokufinyelela ngempumelelo uguquko lwedijithali.
Ukusabela esidingweni samabhizinisi amaningi, Igatsha Lezokukhiqiza Ezihlakaniphile Nezokuqapha Le-China Medical Device Industry Association lasungulwa ngokusemthethweni.Ngokuboniswa kwezandla, u-Wu Haoran, IMenenja Jikelele ye-Crown Information Technology (Suzhou) Co., Ltd. ekugcineni wakhethwa njengephini likamongameli weGatsha Lokuqala Elihlakaniphile Lokukhiqiza Nokuhlakanipha, kanye no-Yu Lin, Unjiniyela Omkhulu weNational Medical Medical. I-Devices Industry Technology Innovation Alliance, iqokwe njengonobhala-jikelele weGatsha Lokuqala Elihlakaniphile Lokukhiqiza Nokuqondisa Okukhaliphile.Ngemva kokusungulwa ngokusemthethweni kweGatsha LokuPhatha Okukhaliphile, lizoqhubeka nokunxenxa amalungu kuwo wonke amazinga, okuhlanganisa nochwepheshe namabhizinisi, futhi labo abanenhloso nabahlangabezana nemibandela bamukelekile ukuthi bafake izicelo.Inhloso yekomidi elincane ukusebenzela nokukhuthaza ukuthuthukiswa kokukhiqiza okuhlakaniphile nokuqondisa okukhaliphile embonini yemishini yezokwelapha, kanye nokubeka phambili iziphakamiso, izinyathelo kanye namazinga emboni yemikhiqizo yomsebenzi ohlobene.Emabhizinisini afuna ukwenza uguquko lwedijithali, ikomidi elincane lingahlinzeka ngazo zonke izinhlobo zezinsizakalo ezihlobene nokuphathwa kwe-supply chain kanye nenqubo yokukhiqiza.
Imodeli yokulawula yendabuko yokukhiqizwa kwezinkampani zamadivayisi wezokwelapha ngokuvamile idla isikhathi, njengokuhlola okuvamile endaweni kanye namasampula amasampula, futhi inqubo ayiguquguquki ngokwanele ukuphendula ngendlela efika ngesikhathi kubuchwepheshe obusha kanye nokuqanjwa kabusha imakethe.Ngakho-ke, ngokuthuthukiswa kwemboni yemishini yezokwelapha, amanye amazwe nezifunda kancane kancane bethula izindlela zokulawula eziguquguqukayo nezedijithali ukuze kuthuthukiswe ukusebenza kahle nokuvumelana nezimo.
UDkt. Cao Yun, unjiniyela omkhulu wezinga lomcwaningi we-Jiangsu Food and Drug Supervision and Information Center, wenze ukuhlaziya okuqhathanisayo: ukulawula okuhlakaniphile ikakhulukazi ngemikhiqizo enobungozi obukhulu, futhi esikhundleni sokuya kusayithi njengakumodeli yokulawula evamile, ingenziwa ukude nangokusakazwa bukhoma.Indlela enjalo inezinzuzo ezine:
1. umthwalo emabhizinisini ungancishiswa.
2. idatha ingabuyekezwa ngesikhathi, futhi ingaqinisekiswa ngokuya ngokunemba nokusebenza kahle.
3. Ukugadwa kwesilawuli kude kwenziwa ngokusebenzisa ukufakwa kwedijithali ku-inthanethi, futhi izinkinga ezitholakele zingakhunjuzwa engxenyeni yebhizinisi ngesikhathi.
4. Ukuphathwa kwentela okusekelwe ku-pre-calculus nakho kuyasiza.
I-UDI, njengokuhlonza okuyingqayizivele kwemishini yezokwelapha, futhi iyithuluzi elibalulekile ngaphakathi kwemithetho ehlakaniphile.Iningi lamabhizinisi seliwuqedile umsebenzi we-UDI ohlelweni lokulawula okuhlakaniphile.UMnu. Liu Liang, Unjiniyela Omkhulu Wesikhungo Solwazi Sokulawulwa Kwezidakamizwa Sikahulumeni, wabelane ngokusetshenziswa kwenkundla yedatha yedatha yedivayisi yezokwelapha kazwelonke esekelwe ku-UDI, engaqinisa ukubonakala, ukuphelela kanye nokufika ngesikhathi kwedatha yokulandeleka komkhiqizo ngemikhiqizo eyabelwe i-UDI, futhi kube lula. ukugadwa nokulandelwa kwemikhiqizo yiziphathimandla ezilawulayo.Uma ufuna ukwazi okwengeziwe nge-UDI, unganaka ikilasi eliku-inthanethi le-Medical Device Innovation Network, futhi okuqukethwe okuhlobene kokuthi 'I-Unique Identification of Medical Devices (UDI) Compliance and Implementation Training Session' izolayishwa esithangamini esihlobene. ividiyo ukuze ufunde.
Isidingo Sokuguqulwa Kwedijithali Kokukhiqiza Okuhlakaniphile Ezinkampanini Zedivayisi Yezokwelapha
Ukubuka kwezinga lenqubomgomo kazwelonke:
Njengamanje, inqubomgomo kazwelonke iqondisa zonke izimboni ekuguqulweni kwedijithali.2022 May 1, ukuqaliswa "kokuqondisa nokuphathwa kokukhiqizwa kwemishini yezokwelapha" okukhulunywe ngakho: ababhalisiwe bemishini yezokwelapha, amafayili, amabhizinisi okukhiqiza athunyelwe kufanele asungule uhlelo lokuphatha amarekhodi ukuze qinisekisa ukuthi amarekhodi ayiqiniso, anembile, aphelele futhi ayalandeleka.Khuthaza ababhalisile bemishini yezokwelapha, amafayili, amabhizinisi okukhiqiza aphathisiwe ukuthi asebenzise izindlela zobuchwepheshe ezithuthukile zokusungula uhlelo lokuphatha ulwazi ukuze kuqiniswe ukuphathwa kwenqubo yokukhiqiza.(Isahluko III, Isigaba 33)
Amabhizinisi ngokwawo abheka lesi simo:
Umkhuba owandayo wokuguga kwabantu e-China kancane kancane uqeda ukuhlukaniswa kwabantu okwake kwajatshulelwa imboni yezokukhiqiza, okuholela ekwenyukeni kwezindleko zokukhiqiza, ukwehlisa izindleko sekuwumsebenzi ophuthumayo wokusinda nokuthuthukiswa kwamabhizinisi.Ukuze kuhlangatshezwane nale nselelo, izinkampani zidinga ukuthatha izinyathelo ezisebenzayo zokuthuthukisa ukuncintisana kwazo ukuze ziqinisekise ukuthi ukukhiqiza kuyashesha futhi kuyavumelana nezimo.
Hongguan ukunakekela impilo yakho.
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Isikhathi sokuthumela: Sep-25-2023