Yeyiphi imiqathango yokuthumela iimaski kumazwe ahlukeneyo

Thumela ngaphandle ukuya eMelika

I-US Food and Drug Administration (FDA) ichaza ukuba izixhobo zonyango, ukutya, utywala, iziyobisi kunye nezinye iifektri ezingaphandle kwe-United States kufuneka zibhaliswe kwaye i-arhente yase-US kufuneka iqeshwe ngaphambi kokuba zidweliswe e-United States.

I-21CFR Icandelo le-807.40 (A) lichaza ukuba nawuphi na umenzi waseMelika waphesheya obandakanyeka kwimveliso, ukulungiswa, ukudibanisa okanye ukusetyenzwa kwezixhobo zonyango ezigqityiweyo kunye nokungenisa iimveliso e-United States kufuneka ziqhube uBhaliso lokuSekwa ​​kunye noLuhlu lweZixhobo zoNyango.Xa ubhalisa umzi-mveliso, umenzi kufuneka anike ingxelo ngolwazi lwe-arhente yase-US kwi-FDA kwifom ye-elektroniki kwinkqubo yokubhalisa kunye noluhlu (inkqubo ye-FURLS), kuquka igama, idilesi, umnxeba, ifeksi kunye ne-imeyile ye-arhente yase-US.

Kuyo nayiphi na imveliso, amashishini kufuneka abhalise kwaye adwelise iimveliso.

Kwiimveliso zeKlasi I (ukubalwa malunga ne-47%), uLawulo Jikelele lusetyenziswa.Uninzi lweemveliso zinokungena kwimarike yase-US kuphela ngokubhalisa, ukudwelisa kunye nokuphumeza imimiselo ye-GMP (imbalwa kubo ikhululwe kwi-GMP, kwaye ezimbalwa zeemveliso ezigciniweyo kufuneka zingenise izicelo ze-510 (K) kwi-FDA, okt PMN (Isaziso se-Premarket Notification). ));

Thumela ngaphandle ukuya eJapan

Iinkampani zezixhobo zonyango ezinqwenela ukubeka iimveliso zazo kwimarike yaseJapan kufuneka zihlangabezane neemfuno zoMthetho waseJapan woShishino lwezamayeza kunye neSixhobo sezoNyango (PMD Act).

Ukuba iiNkampani zeZixhobo zezoNyango zifuna ukubeka iiMveliso zazo kwiMarike yaseJapan, kufuneka zifezekise iiMfuno zoMthetho weMichiza kunye neSixhobo sezoNyango (uMthetho we-PMD) waseJapan.

I-Arhente ye-Pharmaceutical and Medical Devices Agency (PMDA), isebe eliphantsi le-Ministry of Health, Labour and Welfare (MHLW), nayo ipapashe inani elincinci lemimiselo ngesiNgesi.Nangona kunjalo, iingxaki zolwimi kunye neenkqubo ezintsonkothileyo zesatifikethi ziseyinto enzima yokubhaliswa kwesixhobo sonyango eJapan.

Phantsi kweemfuno zoMthetho we-PMD, inkqubo yobhaliso ye-TOROKU ifuna abavelisi basekhaya babhalise ulwazi lwefektri kwabasemagunyeni abanobuchule basekhaya abagunyaziswe ngurhulumente, kubandakanywa uyilo lwemveliso, imveliso kunye nolwazi olungundoqo lwenkqubo;Abavelisi bamazwe angaphandle kufuneka babhalise ulwazi lomvelisi kunye ne-PMDA.

Ngesicelo soMthetho we-PMD, iNkqubo yoBhaliso ye-Toroku ifuna abavelisi basekhaya ukuba babhalise ulwazi lwefektri kunye nooGunyaziwe baseKhaya abagunyaziswe nguRhulumente, kubandakanywa noYilo lweMveliso, iMveliso kunye nolwazi oluPhambili lweNkqubo;Abavelisi bamanye amazwe kufuneka babhalise ulwazi lomvelisi kunye ne-PMDA.

Thumela kuMzantsi Korea

I-Ministry of Health Welfare (MHW) eMzantsi Korea, ebizwa ngokuba yi-Ofisi yoMphathiswa wezeMpilo ngokufutshane, ijongene nokulawula ukutya, iziyobisi, izimonyo kunye nezixhobo zonyango, kwaye iyona candelo lokunakekelwa kwezempilo.NgokoMthetho weSixhobo sezoNyango, uMphathiswa woKutya kunye noKhuseleko lweZiyobisi (MFDS) phantsi koMphathiswa wezeMpilo kunye neNtlalontle yaseMzantsi Korea unoxanduva lokulawula izixhobo zonyango.

I-Korean Medical Device Law ihlela izixhobo zonyango zibe ziindidi ezine (I, II, III, IV), ezifana kakhulu nokuhlelwa kwe-European Union yezixhobo zonyango.

Umthetho weZixhobo zoNyango zaseKorea Ukwahlula iZixhobo zoNyango zibe ZiziNdidi ezine (I, II, III kunye ne-IV), Ezifana Kakhulu kuHlelo lweZixhobo zoNyango lweManyano yaseYurophu.

Udidi I: izixhobo zonyango ezinobungozi obuncinci;

Udidi II: izixhobo zonyango ezinobungozi obuphantsi;

Udidi lwesithathu: izixhobo zonyango ezinobungozi obuphakathi;

Iklasi IV: Izixhobo zonyango ezinobungozi obuphezulu.

Isiseko sokuhlelwa kwezixhobo zonyango: idigri yomngcipheko, indawo yoqhagamshelwano kunye nexesha kunye nomzimba womntu, ukhuseleko kunye nokusebenza kakuhle kweemveliso.

Izixhobo zeClass I kunye ne-II ziya kuqinisekiswa yi "Medical Device Information Technology Centre (MDITAC)", kunye nezinye iClass II (izixhobo ezitsha), iClass III kunye neClass IV izixhobo ziya kuvunyelwa yiKorea yoKutya kunye noLawulo loKhuseleko lweDrug.

Zonke izixhobo zonyango ezithunyelwa e-Australia kufuneka zenze isicelo sobhaliso lwe-TGA.I-TGA sisishunqulelo soLawulo lweeMpahla zoNyango.Igama layo elipheleleyo yiTherapeutic Goods Administration.Yi-arhente eyongamela izinto zonyango (kubandakanywa amachiza, izixhobo zonyango, iteknoloji yemfuza kunye neemveliso zegazi) e-Australia.

Inkcazo yezixhobo zonyango e-Australia isondele kwi-CE ye-EU, kwaye ukuhlelwa ngokusisiseko kuyahambelana.Ngokwahlukileyo kwi-US FDA, iintlobo zezilwanyana azilawulwa yi-TGA.Ngokufana ne-FDA, kufuneka uchaze isizukulwana