Kuti tiwedzere kudzamisa shanduko yekuongorora nemvumo yemidziyo yekurapa, zvichibva pakuvandudzwa kweindasitiri yemidziyo yekurapa uye kutariswa chaiko uye manejimendi emidziyo yekurapa, zvinoenderana ne "Mitemo Yekutarisira uye Kutungamira kweMidziyo Yekurapa" , "Medical Devices Classification Catalog Dynamic Adjustment Work Procedures", Hurumende yeDrug Administration yakasarudza kugadzirisa zvimwe zviri mukati me "Classification Catalog of Medical Devices".Zviitiko zvakabatanidzwa zvinoziviswa sezvinotevera:
Kugadziriswa kwemakirasi makumi mashanu nemasere ezvigadzirwa zvekurapa zvine chekuita nezviri mu "Medical Device Classification Catalog", iyo chaiyo inogadziriswa inoratidzwa mune annex.
Zvinodiwa Pakuita
(I) Nezve zvigadziriso zviri muAnnex zvine chekuita ne01-01-03 "ultrasonic surgical equipment accessories" mu "ultrasonic cutting and hemostasis head, ultrasonic soft tissue surgical head, ultrasonic suction surgical head" uye 01-01-06 "zamu rotary excision biopsy system uye zvishongedzo” izvo zvinotungamirwa seKirasi III michina yekurapa, kubva pazuva rakaburitswa chiziviso ichi, dhipatimendi rekutonga zvinodhaka richaita, maererano ne “Medical Device Registration and Accessories”, “breast rotary excision puncture tsono uye accessories".Breast rotary excision biopsy system uye zvishongedzo ”mu “Breast rotary excision puncture tsono nezvimwe”, kubva pazuva rechiziviso ichi, madhipatimendi anoona nezvezvinodhaka uye manejimendi zvinoenderana ne “Medical Device Registration and Filing Management Measures” “Pakuzivisa Zvinodiwa Pakunyoreswa Kwemichina Yekurapa uye Mamiriro Egwaro Remvumo” zvichingodaro.Chiziviso paKuburitswa Kwezvinodikanwa Zvekunyoreswa Kwemushonga Wekurapa uye Format Yemvumo Gwaro”, nezvimwewo, bazi rinoona nezvezvinodhaka rinotambira chikumbiro chekunyoreswa kwemidziyo yekurapa zvinoenderana nechikamu chakagadziridzwa.
Nokuti chiziviso chakagamuchirwa kusati kwapera kupedzwa kwemvumo yekunyoresa (kusanganisira kunyoreswa kwekutanga uye kuenderera mberi kwekunyoresa) yezvishandiso zvekurapa, madhipatimendi anoona nezvezvinodhaka uye manejimendi anoramba achiongorora uye kubvumidzwa zvinoenderana nekugamuchirwa kwekutanga kwechikamu, kunyoreswa kunopihwa, kuburitswa kwechitupa chekunyoreswa kwechigadzirwa chekurapa, chakaganhurirwa kuchokwadi kwechitupa chekunyoreswa kwemidziyo yekurapa yenguva yekupedzisira yaZvita 31, 2025, uye mugwaro rekunyoresa remakoramu mushure mekugadziriswa kwechikamu che manejimendi yechigadzirwa.Nekuti akawana chitupa chekunyoresa cheKirasi II michina yekurapa, Zvita 31, 2025 chitupa chekunyoreswa kwechigadzirwa chisati chaenderera mberi, anonyoresa anofanirwa kuve nechekuita zvinoenderana nezvinodiwa zveboka rinoenderana rekutungamira kuti aite nesimba shanduko yekunyoresa. chitupa, pamberi paZvita 31, 2025 kuti upedze kutendeuka.Ita basa rekushandura panguva yechitupa chekutanga chekunyoresa mudziyo wekurapa chinopera, mukuchengetedzwa kwechigadzirwa uye chinoshanda uye chakanyorwa pachiratidziro chezviitiko zvisina tsaona dzakakomba kana tsaona dzemhando, anonyoresa anogona kuenderana nehunhu hwekutanga manejimendi uye zvikamu kune yekutanga. dhipatimendi remvumo kuti rinyorere kuwedzerwa, kuti riwedzerwe, kuve kwechokwadi kwechitupa chekunyoresa mudziyo wekurapa hakuzopfuure Zvita 31, 2025.
Kubva Ndira 1, 2026, zvigadzirwa zvakadaro hazvigadzirwe, kutengwa kunze kwenyika uye kutengeswa pasina kuwana chitupa chekunyoresa cheClass III michina yekurapa zvinoenderana nemutemo.Vagadziri vakakodzera vanofanirwa kuita zvinobudirira basa guru remhando yechigadzirwa uye chengetedzo kuve nechokwadi chekuchengetedza uye kushanda kwezvigadzirwa zvakanyorwa.
(B) yekugadzirisa zviri mukati mezvimwe zvigadzirwa, kubva musi wekuburitswa kwechiziviso ichi, madhipatimendi anoona nezvezvinodhaka uye manejimendi zvichibva pa“Kunyoreswa uye Kunyoreswa Kwemidziyo Yekurapa” “pakuziviswa kwezvinodiwa pakunyoreswa kwemidziyo yekurapa. kuzivisa ruzivo uye kubvumidzwa kwechimiro chegwaro" "pakunyoreswa kweKirasi I michina yekurapa pakuziviswa kwenyaya dzakakodzera" uye zvichingodaro, zvinoenderana neboka rakagadziridzwa kugamuchira chikumbiro chekunyoreswa kwemidziyo yekurapa kana zverekodhi.
Nokuti iyo yakagamuchirwa haisati yapedza mvumo yekunyoresa (kusanganisira kunyoreswa kwekutanga nekuvandudzwa kwekunyoreswa) kwemidziyo yekurapa, madhipatimendi anoona nezvezvinodhaka uye manejimendi anoramba achiongorora uye kubvumidzwa zvinoenderana nechikamu chekutanga chekugamuchirwa, kunyoreswa kunopihwa, kuburitswa kwe chitupa chekunyoresa mudziyo wekurapa, uye mune yekunyoresa setifiketi remekedzo mushure mekugadzirisa kwechikamu chekutonga kwechigadzirwa.
Kumidziyo yekurapa yakanyoreswa, chikamu chayo chekutarisira kubva mukirasi yechitatu yakagadziridzwa kusvika kukirasi yechipiri, chitupa chekunyoresa mudziyo wekurapa munguva yechokwadi inoramba ichishanda.Kana iwe uchida kuenderera mberi, munyoreri anofanirwa kunge ari mune yekurapa chitupa chekunyoresa chitupa chapera mwedzi mitanhatu zuva rekupera risati rasvika, zvinoenderana nechikamu mushure mekuchinja kune yakakodzera dhipatimendi rekutarisa zvinodhaka uye manejimendi kunyorera kunyorera patsva kunyoresa, kupihwa kuvandudzwa. yekunyoresa, zvinoenderana nechikamu chakagadziridzwa che manejimendi yechigadzirwa chakapihwa nechitupa chekunyoresa mudziyo wekurapa.
Kumidziyo yekurapa yakanyoreswa, chikamu chekutungamira kubva mukirasi yechipiri yakagadziridzwa kusvika kirasi yekutanga, chitupa chekunyoreswa kwechigadzirwa chekurapa munguva yechokwadi chinoramba chichishanda.Chitupa chisati chapera, anonyoresa anogona kunyorera rekodhi yechigadzirwa kudhipatimendi rinoenderana.
Setifiketi yekunyoresa mudziyo wekurapa mukati mechokwadi chekuchinja kwekunyoresa, anonyoresa anonyorera kudhipatimendi rekutanga rekunyoresa kuti achinje kunyoreswa.Kana chitupa chekunyoresa chepakutanga chakapihwa zvinoenderana nepakutanga "Medical Device Classification Catalog", chiziviso ichi chinosanganisira shanduko mufaira rekunyoresa chigadzirwa kunofanirwa kuratidzwa mumutsara wekutaura mushure mekuita chiziviso chechikamu chekutarisira chigadzirwa.
(C) madhipatimendi ekutarisa zvinodhaka uye manejimendi pamatanho ese kusimbisa iyo "Medical Device Classification Catalog" kugadziriswa kwemukati kwekushambadzira uye kudzidziswa, uye zvinobudirira kuita basa rakanaka rine chekuita nekuongorora kwechigadzirwa uye kubvumidzwa, kufaira uye kutariswa kwemusika.
Nguva yekutumira: Aug-24-2023