Kusukela ngomhlaka-1 Januwari 2022, zonke izisetshenziswa zezokwelapha ezintsha ezingena emazweni e-Eurasian Economic Union njenge-Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, njll. kumele zibhaliswe ngokuvumelana nemithetho yeNyunyana ye-EAC MDR. Bese wamukela isicelo sesitifiketi sokubhaliswa kwedivayisi yezokwelapha ezweni elilodwa. Imishini yezokwelapha ebhaliswe eRussian Federation ingaqhubeka nokusetshenziswa, noma isitifiketi esibhalisiwe singashintshwa kuze kube ngu-2027.
I-EAC MDR Product Classification
Ngokwamazinga ahlukene engcuphe, i-EAC MDR ingahlukaniswa ibe Ikilasi I, Ikilasi IIa, Ikilasi IIb, Ikilasi III, lapho Ikilasi III linezinga eliphakeme kakhulu lengozi, elifana ne-European Union. Uma izinga lobungozi liphakeme, kulapho izinqubo zokubhalisa nezimfuneko ziphakama khona.
Inqubo Yokuqinisekisa Isitifiketi se-EAC MDR
1. Ukunqunywa kwezinga lobungozi kanye nohlobo lwegama lokusetshenziswa 2. Ukunqunywa kohlu lokuhlola imibhalo 3. Ukuqoqwa kobufakazi bokuphepha nokusebenza ngempumelelo 4. Ukukhethwa kwesimo sereferensi nesimo sokuhlonza
5. Khokha intela yentela
6. Thumela imibhalo
7. Ukuhlolwa kokukhiqizwa kwemishini yezokwelapha, njll.
8. Inqubo yokugunyaza
9. Ukubhaliswa kwemishini yezokwelapha
Ulwazi lwesitifiketi se-EAC MDR
Uhlu olulandelayo lwemininingwane luyazikhethela, kuye ngezinga lobungozi lomkhiqizo ukuze kuqinisekiswe ukuthi udinga ukuhlinzekwa.
1. Faka isicelo ngefomu elishiwo kusithasiselo
2 kanye no-3 “Kwemithetho Yokubhalisa Nezobungcweti Yokuphepha, Ikhwalithi kanye Nempumelelo Yamadivayisi Ezokwelapha”
3. Incwadi yokugunyaza emele izintshisekelo zomenzi lapho kubhaliswa
4. Ikhophi yesitifiketi sohlelo lokuphathwa kwekhwalithi yomkhiqizi wedivaysi yezokwelapha (ISO 13485 noma amazinga afanele esifunda noma kazwelonke amazwe angamalungu)
5. Isimemezelo sokuphepha nokufaneleka kwedivayisi yezokwelapha noma idokhumenti efanayo
6. Isitifiketi sokubhaliswa esikhishwe yizwe lokukhiqiza ( Ikhophi yesitifiketi sokudayiswa kwamahhala, isitifiketi sokuthekelisa (ngaphandle kwamadivayisi ezokwelapha akhiqizwa okokuqala endaweni yeZwe eliyiLungu) futhi ahunyushelwe olimini lwesiRashiya.
7. Ikhophi yemibhalo eqinisekisa ukubhaliswa kwamanye amazwe
8. Isitifiketi sedivayisi yezokwelapha esisho Ububanzi, ukusetshenziswa, izici ezimfushane, izinguqulo nezisekeli (amafomu)
9. Idatha yokumaka nokupakisha (isakhiwo esinemibala egcwele yokupakishwa namalebula, umbhalo omakiwe ngesiRashiya nezilimi ezisemthethweni zamazwe angamalungu)
10. Ulwazi lokuthuthukiswa kanye nokukhiqiza: imidwebo yenqubo yokukhiqiza, Izinyathelo zokukhiqiza eziyinhloko, ukupakisha, ukuhlolwa kanye nezinqubo zokugcina zokukhishwa komkhiqizo
11. Ulwazi mayelana nomakhi: igama, uhlobo lomsebenzi, ikheli elisemthethweni, uhlobo lobunikazi, ukwakheka kwabaphathi, uhlu lweminyango nezinkampani ezingaphansi, kanye nencazelo yesimo namandla abo.
12. Umbiko Wezigameko Nokukhunjuzwa (awunikezi ulwazi ngemishini yezokwelapha esanda kuthuthukiswa neyaklanywa): uhlu lwezehlakalo ezimbi noma izigameko ezihlobene nokusetshenziswa kocingo, kanye nenkomba yesikhathi lezo zenzakalo ezenzeka ngaso, uma kukhona ziningi kakhulu izehlakalo ezimbi, kungase kudingeke ukuthi Izinhlobo Zezigameko Nikeza kafushane futhi ibonise inani lezehlakalo ezibikiwe ngohlobo ngalunye A uhlu lwamazwana kanye/noma izaziso ezichazayo zemakethe yemishini yezokwelapha kanye incazelo yezehlakalo, izindlela zokubhekana nazo kanye nezomkhiqizi esimweni ngasinye Isixazululo sichaza ukuhlaziya kanye/noma izinyathelo zokulungisa okufanele zithathwe ekubhekaneni nalezi zimo 13. Uhlu lwamazinga oluhambisana nawo umshini wezokwelapha (nolwazi olufanele)
14. Izidingo ezijwayelekile, izidingo zokulebula kanye Nolwazi oludingwa imibhalo yokusebenza (ngemuva kwalokhu okuzobizwa ngokuthi - izimfuneko ezijwayelekile)
15. Amadokhumenti asungula izidingo zezimpawu zobuchwepheshe zemishini yezokwelapha 16. Imibiko yokuhlolwa kobuchwepheshe okwenziwa ukukhombisa ukuhambisana nezidingo ezijwayelekile.
17. Amaphrothokholi ezifundo (ukuhlola) ukuhlola imiphumela yezinto eziphilayo zemishini yezokwelapha, Ihlose ukukhombisa ukuhambisana nezidingo ezijwayelekile.
18. Ubufakazi bezokwelapha bubika ngokusebenza ngempumelelo nokuphepha kwemishini yezokwelapha
19. Imibiko yokuhlaziya ubungozi
20. Idatha yomuthi ezithakweni zedivayisi yezokwelapha (ukwakheka kwezidakamizwa, inani, idatha ehambelana nezidakamizwa nedivayisi yezokwelapha, Ukubhaliswa komkhiqizo womuthi ezweni okhiqizwa kulo)
21. Idatha ye-Biosafety
22. Idatha yenqubo yokuvala inzalo, okuhlanganisa ukuqinisekiswa kwenqubo, imiphumela yokuhlolwa kwe-microbiological (izinga le-bioburden), i-pyrogenicity, ubunyumba (uma kudingekile), kanye nemiyalelo yendlela yokuhlola nokupakishwa Ulwazi ngedatha yokuqinisekisa (imikhiqizo oyinyumba)
23. Ulwazi oluqondile lwesofthiwe (uma lukhona): Ulwazi lomkhiqizi mayelana nokuqinisekiswa kwesofthiwe
24. Umbiko wocwaningo lokuzinza - ngokuhumusha okuyiqiniso kwesiRashiya kwemiphumela yokuhlolwa neziphetho zemikhiqizo eneshelufu
25. Ukusetshenziswa emazweni aziwayo Imibhalo yokusebenza noma imiyalelo yokusetshenziswa kwensiza yezokwelapha ngolimi lwesizwe (uma kunesidingo) nangesiRashiya.
26. Izincwadi zesevisi (uma kuyizingxenye zemishini yezokwelapha) - uma ingekho idatha emibhalweni yokusebenza
27. Imibiko yokuhlolwa kokukhiqizwa 28. Izinhlelo zokuqoqwa nokuhlaziywa kwedatha yokuphepha nokusebenza ngempumelelo kwemishini yezokwelapha esigabeni sangemuva kokumakethwa.