Yiziphi Izimo Zokuthumela Imaski Emazweni Ahlukene

Thumela e-United States

I-US Food and Drug Administration (FDA) ibeka ukuthi izisetshenziswa zezokwelapha, ukudla, utshwala, izidakamizwa nezinye izimboni ezingaphandle kwase-United States kufanele zibhaliswe futhi kuqokwe i-ejenti yase-US ngaphambi kokuthi ibalwe e-United States.

I-21CFR Ingxenye 807.40 (A) ibeka ukuthi noma yimuphi umkhiqizi waphesheya kwezilwandle waseMelika ohlanganyele ekukhiqizeni, ekulungiseni, ekuhlanganiseni noma ekucubunguleni izisetshenziswa zezokwelapha eziqediwe kanye nokungenisa imikhiqizo e-United States udinga ukwenza Ukubhaliswa Kokusungulwa kanye Nokufakwa Kuhlu Kwedivayisi Yezokwelapha.Lapho ubhalisa imboni, umkhiqizi udinga ukubika ulwazi lwe-ejenti yase-US ku-FDA ngendlela ye-elekthronikhi ohlelweni lokubhalisa nokufakwa kuhlu (uhlelo lwe-FURLS), okuhlanganisa igama, ikheli, ucingo, ifeksi kanye ne-imeyili yomenzeli wase-US.

Kunoma yimuphi umkhiqizo, amabhizinisi adinga ukubhalisa futhi aklelise imikhiqizo.

Emikhiqizweni Yekilasi I (ibalwa cishe ngama-47%), Ukulawulwa Okujwayelekile kuyasetshenziswa.Iningi lemikhiqizo ingangena emakethe yase-US kuphela ngokubhalisa, ukufaka kuhlu nokusebenzisa izicaciso ze-GMP (imbalwa yayo ikhululiwe ku-GMP, futhi embalwa yemikhiqizo egodliwe idinga ukuhambisa izicelo ezingama-510 (K) ku-FDA, okungukuthi i-PMN (Isaziso Esingaphambi Kwemakethe ));

Thumela e-Japan

Izinkampani zemishini yezokwelapha ezifisa ukubeka imikhiqizo yazo emakethe yase-Japan kufanele zihlangabezane nezimfuneko zoMthetho we-Japanese Pharmaceutical And Medical Device Act (PMD Act).

Uma Izinkampani Zedivayisi Yezokwelapha Zifuna Ukufaka Imikhiqizo Yazo Emakethe YaseJapan, Kufanele Zihlangabezane Nezidingo Zomthetho Wedivaysi Yezemithi Nezokwelapha (Umthetho we-PMD) waseJapan.

I-Pharmaceutical and Medical Devices Agency (PMDA), umnyango ongaphansi we-Ministry of Health, Labour And Welfare (MHLW), nayo ishicilele inombolo encane yemithethonqubo ngesiNgisi.Kodwa-ke, izinkinga zolimi nezinqubo eziyinkimbinkimbi zesitifiketi kuseyiphuzu elinzima ekubhalisweni kwedivayisi yezokwelapha e-Japan.

Ngaphansi kwezimfuneko zoMthetho we-PMD, uhlelo lokubhalisa lwe-TOROKU ludinga ukuthi abakhiqizi basekhaya babhalise imininingwane yefekthri neziphathimandla zendawo ezigunyazwe uhulumeni, okuhlanganisa ukwakhiwa komkhiqizo, ukukhiqizwa kanye nolwazi olubalulekile lwenqubo;Abakhiqizi bakwamanye amazwe kufanele babhalise imininingwane yomkhiqizi ne-PMDA.

Ngokwesicelo Somthetho we-PMD, Uhlelo Lokubhalisa I-Toroku Ludinga Abakhiqizi Basekhaya Ukuba Babhalise Ulwazi Lwefekthri Neziphathimandla Zasendaweni Ezigunyazwe Nguhulumeni, Kubandakanya Ukuklanywa Komkhiqizo, Ukukhiqiza kanye Nokwaziswa Kwenqubo Eyinhloko;Abakhiqizi Bangaphandle Kufanele Babhalise Ulwazi Lomkhiqizi Ne-PMDA.

Thekelisa ENingizimu Korea

I-Ministry of Health Welfare (MHW) e-South Korea, ebizwa ngamafuphi njengoMnyango Wezempilo, inesibopho esikhulu sokuphatha ukudla, izidakamizwa, izimonyo nemishini yezokwelapha, futhi iwumkhakha wokunakekelwa kwezempilo oyinhloko.Ngokomthetho Wedivayisi Yezokwelapha, uMnyango Wezokudla Nezokuphepha Kwezidakamizwa (i-MFDS) ngaphansi Komnyango Wezempilo Nenhlalakahle YaseNingizimu Korea unesibopho sokugadwa kwemishini yezokwelapha.

I-Korean Medical Device Law ihlukanisa izisetshenziswa zezokwelapha zibe izigaba ezine (I, II, III, IV), ezifana kakhulu nesigaba se-European Union semishini yezokwelapha.

Umthetho Wamadivayisi Ezokwelapha WaseKorea Uhlukanisa Amadivayisi Ezokwelapha Ngezigaba Ezine (I, II, III kanye Nesi-IV), Okufana Kakhulu Nokuhlelwa Kwe-European Union Yamadivayisi Ezokwelapha.

Ikilasi I: imishini yezokwelapha enengozi encane engaba khona;

Ikilasi II: imishini yezokwelapha enengozi ephansi engaba khona;

I-Class III: imishini yezokwelapha enobungozi obuphakathi;

Ikilasi IV: Imishini yezokwelapha enobungozi obukhulu.

Isisekelo sokuhlukaniswa semishini yezokwelapha: idigri yobungozi, indawo yokuxhumana nesikhathi nomzimba womuntu, ukuphepha nokusebenza ngempumelelo kwemikhiqizo.

Amathuluzi e-Class I kanye ne-II azogunyazwa "Isikhungo Sokusekela Ubuchwepheshe Bolwazi Lwedivayisi Yezokwelapha (MDITAC)", kanti ezinye ze-Class II (izinto ezintsha), I-Class III kanye ne-Class IV zizogunyazwa i-Korean Food and Drug Safety Administration.

Zonke izisetshenziswa zezokwelapha ezithunyelwa e-Australia zidinga ukufaka isicelo sokubhaliswa kwe-TGA.I-TGA isifinyezo se-Therapeutic Goods Administration.Igama layo eligcwele iTherapeutic Goods Administration.Yisikhungo esigadayo sempahla yokwelapha (okuhlanganisa izidakamizwa, izisetshenziswa zezokwelapha, ubuchwepheshe bofuzo kanye nemikhiqizo yegazi) e-Australia.

Incazelo yemishini yezokwelapha e-Australia iseduze ne-CE ye-EU, futhi ukuhlukaniswa kuyahambisana.Ihlukile ku-US FDA, izinhlobo zezilwane azilawulwa yi-TGA.Ngokufanayo ne-FDA, udinga ukucacisa isizukulwane