Zomwe zasinthidwa kumene za ' Regulations on the Supervision and Administration of Medical Devices ( State Council Decree No.739, zomwe zimadziwika kuti ' Regulations ' ) zidzayamba pa June 1,2021.Bungwe la National Drug Administration likukonzekera kukonzekera ndi kukonzanso malamulo othandizira, malemba ovomerezeka ndi malangizo aukadaulo, omwe adzasindikizidwa motsatira ndondomekoyi.Zilengezo za kukhazikitsidwa kwa ' Regulations ' zatsopano ndi izi :
1. Pakukwaniritsidwa kwathunthu kwa kulembetsa kwa chipangizo chachipatala, dongosolo lolemba
Kuyambira pa Juni 1, 2021, mabizinesi onse ndi mabungwe otukula zida zamankhwala omwe ali ndi ziphaso zolembetsera zida zachipatala kapena atagwira ntchito yosunga zida zachipatala za Gulu I, malinga ndi zomwe zili m'malamulo atsopanowa, akwaniritse zomwe olembetsa ndi ma filer zida zachipatala ziyenera kukhazikitsidwa. motsatana, kulimbikitsa kasamalidwe kabwino ka zida zamankhwala munthawi yonse ya moyo, ndikukhala ndi udindo woteteza ndi kuchita bwino kwa zida zamankhwala panthawi yonse yofufuza, kupanga, kugwiritsa ntchito ndikugwiritsa ntchito motsatira malamulo.
2. Pa kulembetsa kwa chipangizo chachipatala, kasamalidwe ka mafayilo
Kuyambira pa June 1, 2021, asanatulutsidwe ndi kukhazikitsidwa kwa zofunikira zokhudzana ndi kulembetsa ndi kusungitsa 'Malamulo' atsopano, ofunsira kulembetsa zida zachipatala ndi ma fayilo akupitilizabe kulembetsa kulembetsa ndi kusungitsa malinga ndi malamulo omwe alipo.Zofunikira pakuwunika kwachipatala pazida zamankhwala zidzakhazikitsidwa molingana ndi Ndime 3 ya Chilengezo ichi.Dipatimenti yoyang'anira mankhwala ndi kasamalidwe ka mankhwala imagwira ntchito zolembetsa ndikulemba mafayilo molingana ndi njira zomwe zilipo komanso malire a nthawi.
3. Utsogoleri wa Kuwunika Kwachipatala kwa Zida Zachipatala
Kuyambira pa Juni 1, 2021, olembetsa zida zachipatala ndi olembetsa aziwunika zachipatala motsatira 'Malamulo' atsopano.omwe akutsatira zomwe zili mu "Regulations" zatsopano akhoza kumasulidwa ku kafukufuku wachipatala;kuunika kwachipatala kumatha kutengera mawonekedwe azinthu, chiopsezo chachipatala, zomwe zilipo kale, ndi zina zambiri, kudzera m'mayesero azachipatala, kapena kudzera m'mabuku a zamankhwala osiyanasiyana, kusanthula deta yazachipatala ndikuwunika kutsimikizira kuti zida zamankhwala ndizotetezeka komanso zothandiza;mabuku mankhwala alipo, matenda deta sikokwanira kutsimikizira mankhwala chitetezo, ogwira mankhwala zipangizo, ayenera kuchita mayesero kuchipatala.Asanatulutsidwe ndi kukhazikitsidwa kwa zikalata zoyenera zomwe sizikuyesedwa pakuwunikiridwa kwachipatala, mndandanda wa zida zamankhwala zomwe sizimawunikiridwa pakuwunika kwachipatala zimakhazikitsidwa potengera mndandanda wamakono wa zida zamankhwala zomwe sizimayesedwa m'mayesero azachipatala.
4.About laisensi yopanga zida zamankhwala, kasamalidwe ka mafayilo
Asanatulutsidwe ndi kukhazikitsidwa kwa zofunikira za 'Malamulo' atsopano othandizira zilolezo zopangira ndi kusungitsa, olembetsa zida zamankhwala ndi ma filer amasamalira zilolezo zopanga, kusungitsa ndi kutumiza ntchito molingana ndi malamulo omwe alipo ndi zikalata zokhazikika.
5.Pachilolezo cha bizinesi ya chipangizo chamankhwala, kasamalidwe ka mafayilo
Chida chachipatala cholembetsedwa kapena cholembetsedwa ndi chipangizo chachipatala cholembetsedwa kapena munthu wolembetsedwa yemwe amagulitsa chida chachipatala cholembetsedwa kapena kulembetsedwa komwe amakhala kapena adilesi yopangira sichifuna laisensi yabizinesi ya chipangizo chachipatala kapena kulembetsa, koma chikuyenera kutsatira zomwe zanenedwa;ngati mtundu wachiwiri ndi wachitatu wa zida zamankhwala zikusungidwa ndikugulitsidwa m'malo ena, chilolezo chabizinesi yazida zamankhwala kapena zolemba ziyenera kukonzedwa motsatira zomwe zaperekedwa.
Boma la State Drug Administration lalemba mndandanda wa zida zachipatala za gulu II zomwe sizikuloledwa kulembetsa mabizinesi ndipo likufuna upangiri wa anthu.Katundu wazinthu akatulutsidwa, tsatirani kalozera.
6.Kufufuza ndi chilango cha khalidwe losaloledwa ndi chipangizo chachipatala
Ngati khalidwe losaloledwa pazida zamankhwala lidachitika June 1, 2021 asanakwane, "Malamulo" asanaunikenso adzagwiritsidwa ntchito.Komabe, ngati "Malamulo" atsopano akuwona kuti sizololedwa kapena chilangocho ndi chopepuka, "Malamulo" atsopano adzagwiritsidwa ntchito.'Malamulo' atsopano amagwira ntchito pomwe cholakwacho chidachitika pambuyo pa 1 June 2021.
Izi zikulengezedwa.
National Drug Administration
Meyi 31, 2021
Nthawi yotumiza: Jun-01-2021