Chidule cha Policy |Chilengezo cha State Drug Administration pa Kusintha kwa Gawo la Catalogue ya Medical Device Classification

Pofuna kupititsa patsogolo kukonzanso kachitidwe kakuwunika ndi kuvomereza zida zachipatala, kutengera chitukuko cha zida zamankhwala komanso kuyang'anira ndi kuyang'anira zida zamankhwala, molingana ndi "Regulations for Supervision and Management of Medical Devices" , "Medical Devices Classification Catalog Dynamic Adjustment Work Procedures", State Drug Administration yaganiza zosintha zina mwa "Classification Catalogue of Medical Devices".Zinthu zofunika zimalengezedwa motere:

Kusintha kwa magulu a 58 a zipangizo zamankhwala zokhudzana ndi zomwe zili mu "Medical Device Classification Catalog", zosintha zenizeni zikuwonetsedwa mu zowonjezera.

Zofunikira pakukhazikitsa

(I) Pakuti zosintha mu Annex zokhudzana 01-01-03 “akupanga opaleshoni zida Chalk” mu “akupanga kudula ndi hemostasis mutu, akupanga zofewa minofu opaleshoni mutu, akupanga mayamwidwe opaleshoni mutu” ndi 01-01-06 “bere rotary excision biopsy system ndi zowonjezera" zomwe zimayendetsedwa ngati zida zachipatala za Gulu lachitatu, kuyambira tsiku lomwe chilengezochi chinasindikizidwa, dipatimenti yoyang'anira zachipatala, molingana ndi "Medical Device Registration and Accessories", "mabere rotary puncture singano ndi zowonjezera".Breast rotary excision biopsy system ndi zowonjezera" mu "breast rotary excision puncture singano ndi zowonjezera", kuyambira tsiku la chilengezo ichi, dipatimenti yoyang'anira mankhwala ndi kasamalidwe ka mankhwala molingana ndi "Medical Device Registration and Filing Management Measures" "Pa Chilengezo cha Zofunika Pakulembetsa Zida Zachipatala ndi Mawonekedwe a Chikalata Chovomerezeka” ndi zina zotero.Chilengezo cha Publication of Requirements for Medical Deregistration and Format of Approval Document”, ndi zina zotero, dipatimenti yoyang’anira mankhwala idzavomereza pempho lolembetsa zida zachipatala molingana ndi gulu lomwe lasinthidwa.

Pakuti chilengezo chavomerezedwa chisanamalize chivomerezo cholembetsa (kuphatikizapo kulembetsa koyamba ndi kupitiriza kulembetsa) zipangizo zachipatala, madipatimenti oyang'anira mankhwala ndi kayendetsedwe ka mankhwala akupitiriza kuwunika ndi kuvomereza mogwirizana ndi kuvomereza koyambirira kwa gulu, kulembetsa kumaperekedwa, kuperekedwa kwa satifiketi yolembetsa chida chachipatala, chochepera pa kutsimikizika kwa satifiketi yolembetsa zida zamankhwala patsiku lomaliza la Disembala 31, 2025, komanso pagawo la ndemanga za satifiketi yolembetsa pambuyo pa kusintha kwa gulu la kasamalidwe kazinthu.Popeza adalandira satifiketi yolembetsa ya zida zachipatala za Class II, Disembala 31, 2025 satifiketi yolembetsa zinthu isanapitirire kukhala yovomerezeka, wolembetsa ayenera kutenga nawo gawo molingana ndi zofunikira za gulu loyang'anira lomwe likugwirizana kuti akwaniritse kutembenuka kwa kalembera. satifiketi, pasanafike pa Disembala 31, 2025 kuti amalize kutembenuka.Kugwira ntchito kutembenuka pa chiyambi cha chiphaso chachipatala kulembetsa satifiketi kutha, mu chitetezo mankhwala ndi ogwira ndi kutchulidwa pa maziko a palibe zochitika zoopsa kwambiri kapena ngozi khalidwe, wolembetsa akhoza kukhala molingana ndi makhalidwe oyambirira kasamalidwe ndi magulu oyambirira. dipatimenti yovomerezeka yofunsira chiwonjezeko, kuti iwonjezeke, kutsimikizika kwa chiphaso choyambirira cholembetsa chida chachipatala sikudutsa Disembala 31, 2025.

Kuyambira pa Januware 1, 2026, zinthu zotere sizidzapangidwa, kutumizidwa kunja ndikugulitsidwa popanda kupeza chiphaso cholembetsa cha zida zamankhwala za Gulu lachitatu motsatira malamulo.Opanga oyenerera akuyenera kutsata bwino lomwe udindo waukulu wamtundu wazinthu ndi chitetezo kuwonetsetsa kuti zinthu zomwe zatchulidwazi zili zotetezeka komanso zogwira mtima.

(B) pakusintha zomwe zili muzinthu zina, kuyambira tsiku lomwe chilengezochi chinatulutsidwa, dipatimenti yoyang'anira mankhwala ndi kasamalidwe ka mankhwala malinga ndi "Registration and Filing of Medical Devices" "pakulengeza zofunikira pakulembetsa zida zamankhwala. kulengeza zidziwitso ndi kuvomereza mawonekedwe a chikalatacho" "pakusungidwa kwa zida zachipatala za Class I pa kulengeza zinthu zoyenera" ndi zina zotero, molingana ndi gulu lomwe lasinthidwa kuvomera kulembetsa kulembetsa kwa zida zamankhwala kapena kwa mbiri.

Kwa ovomerezeka sanamalize chivomerezo cholembetsa (kuphatikiza kulembetsa koyamba ndi kukonzanso kalembera) kwa zida zamankhwala, dipatimenti yoyang'anira mankhwala ndi kasamalidwe ka mankhwala akupitilizabe kuwunikira ndikuvomerezedwa molingana ndi gulu loyambirira la kuvomereza, kulembetsa kumaperekedwa, kuperekedwa kwa satifiketi yolembetsa chida chachipatala, ndipo mugawo la ndemanga za satifiketi yolembetsa pambuyo pa kusintha kwa gulu la kasamalidwe kazinthu.

Kwa zida zamankhwala zolembetsedwa, gulu lake loyang'anira kuchokera ku gulu lachitatu losinthidwa kukhala kalasi yachiwiri, satifiketi yolembetsa chida chachipatala mu nthawi yovomerezeka ikupitilizabe kukhala yovomerezeka.Ngati mukufuna kupitiriza, wolembetsa ayenera kukhala mu chiphaso chachipatala kulembetsa satifiketi ikutha miyezi 6 isanafike tsiku lotha, malinga ndi gulu pambuyo kusintha kwa yoyenera mankhwala kuyang'aniridwa ndi kasamalidwe dipatimenti yofunsira kukonzanso kulembetsa, anapatsidwa kukonzanso. kulembetsa, molingana ndi gulu losinthidwa la kasamalidwe kazinthu koperekedwa ndi satifiketi yolembetsa ya chipangizo chachipatala.

Kwa zida zamankhwala zolembetsedwa, gulu lake loyang'anira kuchokera ku kalasi yachiwiri losinthidwa kukhala kalasi yoyamba, satifiketi yolembetsa chida chachipatala mu nthawi yovomerezeka ikupitilizabe kukhala yovomerezeka.Satifiketi yolembetsa isanathe, wolembetsa atha kulembetsa zolemba zamalonda ku dipatimenti yofananira.

Satifiketi yolembetsa ya chipangizo chachipatala mkati mwa kutsimikizika kwakusintha kolembetsa, wolembetsa adzafunsira ku dipatimenti yolembetsa yoyambirira kuti asinthe kulembetsa.Ngati satifiketi yolembetsa yoyambirira yaperekedwa molingana ndi "Katalogi Yoyang'anira Zida Zachipatala" yoyambirira, chilengezochi chikukhudza kusintha kwa fayilo yolembetsera katundu kuyenera kuwonetsedwa mugawo la ndemanga pambuyo pa kukhazikitsidwa kwa chilengezo cha gulu loyang'anira malonda.

(C) madipatimenti oyang'anira mankhwala ndi kasamalidwe m'magulu onse kuti alimbitse "Medical Device Classification Catalog" kusintha kwazinthu zofalitsa ndi maphunziro, ndikuchita bwino ntchito yabwino yokhudzana ndi kuwunika kwa mankhwala ndi kuvomereza, kusungitsa ndi kuyang'anira pambuyo pa msika.