I-China yokutya kunye noLawulo lweeDrug ikhuphe ingxelo entsha ye "Ikhathalogu yokuHanjiswa kwezixhobo zezoNyango" ukuqala nge-1 Agasti 2018

Nge-4 kaSeptemba, i-2017, i-State Food and Drug Administration (ekuthiwa yi “General Administration”) yabamba inkomfa noonondaba ukukhulula ngokusesikweni “Ikhathalogu yokuHlulwa kweZixhobo zezoNyango” (apha ekuthiwa yi “Catalogue Classification” entsha ”). Ukuqala ngo-Agasti 1, 2018.

Ulawulo lokuhlelwa kwezixhobo zonyango yindlela eyamkelweyo yolawulo eyamkelwa kwilizwe liphela, kwaye ulwahlulo lwezixhobo zonyango kunye nolwazelelekileyo sisiseko esibalulekileyo sokujonga yonke inkqubo yobhaliso lwezixhobo zonyango, imveliso, ukusebenza kunye nokusetyenziswa.

Okwangoku, kukho malunga nezatifikethi zobhaliso lwezixhobo zonyango ezingama-77,000 kunye nezatifikethi zobhaliso ezingaphezulu kwama-37,000 e-China. Ngophuhliso olukhawulezileyo lweshishini lezixhobo zonyango kunye nokuvela okuqhubekekayo kobuchwephesha obutsha kunye neemveliso ezintsha, inkqubo yokuhlelwa kwezixhobo zonyango khange ikwazi ukuhlangabezana neemfuno zophuhliso lwamashishini kunye nomsebenzi wolawulo. Inguqulelo ka-2002 “yoLwahlulo lwezixhobo zoNyango lwezixhobo zezoNyango” (apha ekuza kuthiwa yi-“Classification Catalog” yoqobo) Iziphene zolu shishino ziye zaqaqamba ngakumbi: Okokuqala, “iKhathalogu yoHlelo” yoqobo ayichazwanga ngokwaneleyo, kwaye Inkqubo-sikhokelo iyonke kunye nokumiselwa kwenqanaba akunakuhlangabezana nemeko yangoku yeshishini kunye neemfuno zolawulo. Okwesibini, "iKhathalogu" yoqobo yayingenalo ulwazi oluphambili olufana nenkcazo yemveliso kunye nokusetyenziswa okujolise kuko, okuchaphazele ukufana kunye nokubekwa emgangathweni kwemvume yobhaliso. Okwesithathu, "iCandelo lekhathalogu" yoqobo yayinzima ukugubungela iimveliso ezintsha kunye neendidi ezintsha. Ngenxa yokunqongophala kohlengahlengiso lwamandla, umxholo wekhathalogu awunakuhlaziywa ngexesha, kwaye icandelo lodidi lweemveliso aluzange lube sengqiqweni.

Ukulungiselela ukumiliselwa kwe "Migaqo yoLawulo noLawulo lwezixhobo zezoNyango" ehlaziyiweyo yabhengezwa liBhunga likaRhulumente kunye "neZimvo zeBhunga likaRhulumente ngokuHlaziya ukuHlola nokuVunywa kwenkqubo yeziyobisi kunye nezixhobo zonyango", Ukutya kukaRhulumente kunye neziyobisi Ulawulo luzishwankathele kwaye luhlalutye izixhobo zonyango ezikhutshwe kwiminyaka edlulileyo ngokungqinelana nokuhanjiswa kohlaziyo lolawulo lwezixhobo zonyango. Ukuhlelwa kwesixhobo kunye neefayile zenkcazo, ukuhlela ulwazi lweemveliso zobhaliso lwezixhobo ezisemthethweni, kunye nokuphanda kulawulo lwezixhobo zonyango ezifanayo zangaphandle. Umsebenzi wokuhlaziya usungulwe ngoJulayi 2015, kwaye ukwenziwa ngokupheleleyo kunye nokulungiswa kwesakhelo, ubume kunye nomxholo "weKhathalogu yoHlelo" lwenziwa. Misela iKomiti yobuGcisa yokuHlela isiXhobo sezoNyango kunye neqela layo lobuchwephesha, ibonakalise inkqubo kunye nobungqiqo beziqulatho ze "Ikhathalogu yokuHlola", kwaye yahlaziya "iKhathalogu yokuHlola" entsha.

"Ikhathalogu yeCandelo" entsha yahlulwe yangamacandelo angama-22 ngokweempawu zetekhnoloji yezixhobo zonyango kunye nokusetyenziswa kweklinikhi. Amacandelo angaphantsi aqulathwe kwinqanaba lokuqala lemveliso, iindidi zemveliso yenqanaba lesibini, iinkcazo zemveliso, ukusetyenziswa okujolisiweyo, imizekelo yamagama emveliso, kunye neendidi zolawulo. Xa kumiselwa udidi lwemveliso, kufuneka kwenziwe isigqibo esibanzi ngokusekwe kwimeko yokwenene yemveliso, idityaniswe nenkcazo yemveliso, ukusetyenziswa okujoliswe kuyo kunye nemizekelo yamagama emveliso kwiKhathalogu entsha yoHlelo. Ezona mpawu ziphambili zoluhlu “lweKhathalogu yoHlelo” zezi zilandelayo: Okokuqala, olu lwakhiwo lunobunzululwazi ngakumbi kwaye luhambelana ngakumbi nonyango. Ukuzoba izifundo ezivela kwinkqubo yeklinikhi yokujolisa ekusetyenzisweni e-United States, kubhekiswa kulwakhiwo lwe- "Framework Catalogue yamaZiko aManyelwayo eManyano yaseYurophu", iindidi ezingama-43 zekhathalogu yangoku "yoLwahlulo lweKhathalogu" zidityanisiwe zaba ngama-22 amacandelwana, kunye nama-260 iindidi zemveliso ziye zahlanjululwa zaze zahlengahlengiswa kwiindidi zemveliso zenqanaba lokuqala ezingama-206 kunye neendidi zemveliso zenqanaba lesibini ezili-1157 ezenza uluhlu lwemigangatho emithathu yekhathalogu. Okwesibini, ukugubungela kubanzi, kuyafundisa ngakumbi kwaye kuyasebenza. Zingaphezulu kwe-2,000 iimveliso ezintsha ezongezwe ukusetyenziswa okulindelekileyo kunye neenkcazo zemveliso, kwaye ngoku "Ikhathalogu yokuHlola" yandisiwe yaba yimizekelo engama-6 609 yamagama emveliso ayi-1008. Okwesithathu kukulungelelanisa ngokusesikweni iindidi zolawulo lweemveliso, ukuphucula ukulungelelaniswa kwemeko ekuyiyo kushishino kunye nolawulo olululo, kunye nokubonelela ngesiseko sokwaba ulwabiwo lwezixhobo zolawulo. Ngokwenqanaba lomngcipheko wemveliso kunye nolawulo olululo, icandelo lolawulo lweemveliso zonyango ezingama-40 ezinexesha elide lokuthengisa, ukukhula okuphezulu kwemveliso kunye nemingcipheko elawulwayo iyancitshiswa.

The framework and content of the new “Classification Catalog” have been greatly adjusted, which will have an impact on all aspects of medical device registration, production, operation, and use. In order to ensure a unified understanding of all parties, a smooth transition, and orderly implementation, the State Food and Drug Administration simultaneously issued and implemented the “Notice on the Implementation of the Newly Revised <Medical Device Classification Catalog>”, giving nearly a year of implementation transition time. To guide the regulatory authorities and related enterprises to implement. Regarding registration management, fully considering the status quo of the medical device industry, adopting a natural transition channel to implement the new “Classification Catalog”; for post-marketing supervision, production and operation supervision can adopt the new and old classification coding systems in parallel. The State Food and Drug Administration will organize all-round system training on the new “Classification Catalog” and guide local regulatory authorities and manufacturing companies to implement the new “Classification Catalog.”

Ikhathalogu entsha yokwahlula isixhobo sonyango se2018 Umthombo womxholo: China Food and Drug Administration, http://www.sda.gov.cn/WS01/CL0051/177088.html


Ixesha lokuposa: Mar-02-2021