Ngomhla we-4 kuSeptemba, i-2017, i-State Food and Drug Administration (emva koku ebizwa ngokuba yi-"General Administration") ibambe inkomfa yenkomfa ukuze ikhuphe ngokusemthethweni i-"Classification Catalog for Medical Devices" esanda kuhlaziywa (emva koku kuthiwa yiNew "Classification Catalog". ”).Isebenza ukusuka nge-1 ka-Agasti ka-2018.
Ulawulo lokuhlelwa kwesixhobo sonyango luyimodeli yolawulo olwamkelwe kumazwe ngamazwe, kwaye ulwahlulo lwezixhobo zonyango lwenzululwazi nolunengqiqo lusisiseko esibalulekileyo solawulo lwenkqubo yonke yokubhaliswa, ukuveliswa, ukusebenza nokusetyenziswa kwesixhobo zonyango.
Okwangoku, kukho malunga nama-77,000 izatifikethi zobhaliso lwezixhobo zonyango kunye nezatifikethi ezingaphezulu kwama-37,000 zobhaliso lwezixhobo zonyango e-China.Ngophuhliso olukhawulezayo loshishino lwezixhobo zonyango kunye nokuvela okuqhubekayo kobuchwepheshe obutsha kunye neemveliso ezintsha, inkqubo yokuhlelwa kwezixhobo zonyango ayikwazanga ukuhlangabezana neemfuno zophuhliso lwamashishini kunye nomsebenzi wokulawula.Inguqulo ka-2002 ye "Ikhathalogu yoHlelo lweSixhobo soNyango" (emva koku kubhekiselwa kuyo njenge "Ikhathalogu yoHlelo" lwangaphambili) Iintsilelo zeshishini ziye zabonakala ngakumbi nangakumbi: Okokuqala, i-original "Ikhathalogu yoHlelo" alunankcukacha ngokwaneleyo, kwaye Isicwangciso-nkqubo esipheleleyo kunye nokumiselwa kwenqanaba akunako ukuhlangabezana nemo yangoku yoshishino kunye neemfuno zolawulo.Okwesibini, "i-Catalogue" yasekuqaleni yayingenalo ulwazi oluphambili olufana nenkcazo yemveliso kunye nokusetyenziswa okujoliswe kuyo, okuchaphazela ukufana kunye nokulinganisa ukuvunywa kokubhaliswa.Okwesithathu, i-original "Catalog Catalog" kwakunzima ukugubungela iimveliso ezintsha kunye neendidi ezintsha.Ngenxa yokungabikho kwendlela yohlengahlengiso oluguquguqukayo, umxholo wekhathalogu awukwazanga ukuhlaziywa ngexesha, kwaye ulwahlulo lodidi lwemveliso lwalungenangqiqo.
Ukuze kuphunyezwe "iMimiselo yoLawulo kunye noLawulo lweZixhobo zoNyango" ihlaziywe kwaye yabhengezwa liBhunga likaRhulumente kunye "Iimbono zeBhunga leSizwe malunga noHlaziyo lokuHlola kunye nokuVunywa kweNkqubo yeZiyobisi kunye neZixhobo zoNyango", uKutya kukaRhulumente kunye neziyobisi. Ulawulo lushwankathele ngokubanzi kwaye lwahlalutya izixhobo zonyango ezikhutshwe kwiminyaka edlulileyo ngokuhambelana nokusasazwa kohlaziyo lolawulo lwezixhobo zonyango.Ukuhlelwa kwesixhobo kunye neefayile zenkcazo, ukuhlela ulwazi lweemveliso ezisebenzayo zobhaliso lwesixhobo sonyango, kunye nokuphanda ulawulo lwezixhobo zonyango ezifanayo zangaphandle.Umsebenzi wokuhlaziya waphehlelelwa ngoJulayi 2015, kwaye ukwenziwa ngokupheleleyo kunye nohlengahlengiso lwesakhelo, ulwakhiwo kunye nomxholo "weKhathalogi yoHlelo" lwenziwa.Misela iKomidi yezobuGcisa yoHlelo lweSixhobo sezoNyango kunye neqela layo lobuchwephesha, libonise ngokucwangcisiweyo inzululwazi kunye nengqiqo yeziqulatho ze "Ikhathalogu yoHlelo", kwaye ihlaziywe "iKhathalogi yoHlelo" entsha.
I-"Catalog Catalog" entsha yahlulahlulwe yaba ngamacandelwana angama-22 ngokweempawu zobuchwepheshe besixhobo sonyango kunye nokusetyenziswa kweklinikhi.Uluhlu olungaphantsi luqulunqwe ngamacandelo emveliso yenqanaba lokuqala, iindidi zemveliso yenqanaba lesibini, inkcazo yemveliso, ukusetyenziswa okujoliswe kuyo, imizekelo yamagama emveliso, kunye neendidi zolawulo.Xa umisela udidi lwemveliso, ukuzimisela okubanzi kufuneka kwenziwe ngokusekelwe kwimeko yangempela yemveliso, idibaniswe nenkcazo yemveliso, ukusetyenziswa okujoliswe kuyo kunye nemizekelo yegama lemveliso kwi "Ikhathalogu yoHlelo" entsha.Iimpawu eziphambili ze "Ikhathalogu yoHlelo" olutsha zilandelayo: Okokuqala, isakhiwo sinobunzululwazi ngakumbi kwaye sihambelana nokusebenza kweklinikhi.Ukudweba izifundo ezivela kwinkqubo yokuhlelwa kokusetyenziswa kwekliniki e-United States, ebhekiselele kwisakhiwo se-"Framework Catalog for Notified Bodies of the European Union", i-43 sub-catalog ye-"Classification Catalog" yangoku iye yadityaniswa kwi-22. izintlu ezingaphantsi, kunye neendidi zeemveliso ezingama-260 ziye zacokiswa kwaye zahlengahlengiswa ukuya kwiindidi zemveliso zomgangatho wokuqala ezingama-206 kunye neendidi zeemveliso zomgangatho wesibini ezili-1157 zenza uluhlu lwemigangatho emithathu yekhathalogu.Okwesibini, i-coverage ibanzi, iyafundisa ngakumbi kwaye iyasebenza.Ngaphezulu kweemveliso ezitsha ze-2,000 zongezwa kusetyenziso olulindelekileyo kunye neenkcazo zemveliso, kwaye "Ikhathalogu yoHlelo" lwangoku lwandiswe kwimizekelo ye-6,609 yamagama emveliso ye-1008.Okwesithathu kukulungelelanisa ngokwengqiqo iindidi zolawulo lwemveliso, ukuphucula ukuguquguquka kwemeko yeshishini elikhoyo kunye nolona liliso lokwenene, kunye nokubonelela ngesiseko sokwandisa ulwabiwo lwezibonelelo zokongamela.Ngokwenqanaba lomngcipheko wemveliso kunye nolongamelo olululo, udidi lolawulo lweemveliso zezixhobo zonyango ezingama-40 ezinexesha elide lokuthengisa, ukuvuthwa okuphezulu kwemveliso kunye nemingcipheko elawulekayo iyancitshiswa.
Isakhelo kunye nomxholo omtsha we "Ikhathalogu yoHlelo" iye yahlengahlengiswa kakhulu, eya kuba nefuthe kuzo zonke iinkalo zokubhaliswa kwesixhobo sonyango, ukuveliswa, ukusebenza kunye nokusetyenziswa.Ukuqinisekisa ukuqonda okumanyeneyo kwawo onke amaqela, inguqu egudileyo, kunye nokuphunyezwa ngocwangco, uLawulo lokuTya kukaRhulumente kunye noLawulo lweZiyobisi ngaxeshanye lukhuphe kwaye luphumeze “Isaziso sokuPhunyezwa koHlaziyo olutsha.”, enika phantse unyaka wokuphunyezwa kwexesha lenguqu.Ukukhokela iziphathamandla zolawulo kunye namashishini anxulumeneyo ukuba aphumeze.Ngokuphathelele ulawulo lobhaliso, ngokuqwalasela ngokupheleleyo imeko ye-quo yoshishino lwezixhobo zonyango, ukwamkela umjelo wenguqu yendalo ukuphumeza i-"Classification Catalog" entsha;ukwenzela ukubeka iliso emva kokuthengisa, ukubeka iliso kwimveliso kunye nokusebenza kunokwamkela iinkqubo zokuhlelwa kweekhowudi ezintsha nezindala ngokunxuseneyo.I-State Food and Drug Administration iya kuququzelela uqeqesho lwenkqubo ejikelezayo kwi-"Classification Catalog" entsha kwaye ikhokele iziphathamandla zolawulo lwasekhaya kunye neenkampani zokuvelisa ukuphumeza i-"Classification Catalog" entsha.
Ngo-2018 ikhathalogu entsha yokuhlelwa kwesixhobo sonyango
Ixesha lokuposa: Mar-02-2021