Ukususela nge-1 kaJanuwari 2022, zonke izixhobo zonyango ezitsha ezingena kumazwe ase-Eurasian Economic Union afana neRashiya, i-Belarus, i-Kazakhstan, i-Armenia, i-Kyrgyzstan, njl.Emva koko wamkele isicelo sesiqinisekiso sobhaliso lwesixhobo sonyango kwilizwe elinye.Izixhobo zonyango ezibhaliswe kwi-Russian Federation zingaqhubeka zisetyenziswa, okanye isatifikethi esibhalisiweyo sinokutshintshwa kude kube yi-2027.
UHlelo lweMveliso ye-EAC MDR
Ngokwamanqanaba ahlukeneyo engozi, i-EAC MDR inokwahlulwa ibe yiClass I, iClass IIa, iClass IIb, iClass III, apho iClass III inomngcipheko ophezulu kakhulu, ofana ne-European Union.Inqanaba lomngcipheko liphezulu, liphezulu iinkqubo kunye neemfuno zokubhalisa.
Inkqubo yeSiqinisekiso se-EAC MDR
1. Ukumiselwa kwenqanaba lomngcipheko kunye nodidi lwegama lokusetyenziswa 2. Ukumiselwa koluhlu lokutshekisha lwamaxwebhu 3. Ukuqokelelwa kobungqina bokhuseleko nokusebenza ngempumelelo 4. Ukukhethwa kwemeko yereferensi kunye nobume bokuchongwa.
5. Hlawula imirhumo yerhafu
6. Ngenisa amaxwebhu
7. Ukuhlolwa kwemveliso yezixhobo zonyango, njl.
8. Inkqubo yokuVunywa
9. Ukubhaliswa kwesixhobo sezonyango
Ulwazi lweSatifikethi se-EAC MDR
Olu luhlu lulandelayo lolwazi alukhethi, kuxhomekeke kwinqanaba lomngcipheko wemveliso ukuqinisekisa ukuba kufuneka kunikezelwe.
1. Faka isicelo kwifomu echazwe kwiSihlomelo
I-2 kunye ne-3 "yoBhaliso kunye neMithetho yobuNgcali yoKhuseleko, uMgangatho kunye nokuSebenza kweZixhobo zoNyango"
3. Ileta yogunyaziso emele umdla womenzi xa ubhalisa
4. Ikopi yesiqinisekiso senkqubo yolawulo lomgangatho womenzi wesixhobo sonyango (ISO 13485 okanye imigangatho efanelekileyo yengingqi okanye yesizwe yamazwe angamalungu)
5. Isibhengezo sokhuseleko lwesixhobo sonyango kunye nokusebenza ngokufanelekileyo okanye uxwebhu olulinganayo
6. Isiqinisekiso sobhaliso esikhutshwe lilizwe lokuvelisa ( Ikopi yesatifikethi sokuthengiswa kwamahhala, isatifikethi sokuthumela ngaphandle (ngaphandle kwezixhobo zonyango eziveliswe kuqala kwintsimi yeLungu leLungu)) kwaye iguqulelwe kwisiRashiya.
7. Ikopi yamaxwebhu aqinisekisa ukubhaliswa kwamanye amazwe
8. Isiqinisekiso sesixhobo sezonyango esichaza isixhobo sonyango Ubungakanani, ukusetyenziswa, iimpawu ezimfutshane, iinguqulelo kunye nezincedisi (iifomu)
9. Ukumakisha kunye nokupakishwa kwedatha (uyilo olunemibala egcweleyo yokupakisha kunye neelebhile, isicatshulwa esiphawulweyo ngesiRashiya kunye neelwimi ezisemthethweni zamazwe angamalungu)
10. Uphuhliso kunye nolwazi lokuvelisa: imizobo yenkqubo yokuvelisa, Amanyathelo okuvelisa aphambili, ukupakishwa, uvavanyo kunye neenkqubo zokugqibela zokukhutshwa kwemveliso.
11. Ulwazi malunga nomenzi: igama, uhlobo lomsebenzi, idilesi esemthethweni, uhlobo lobunini, ukubunjwa kwabaphathi, uluhlu lwamasebe kunye nee-subsidiaries, kunye nenkcazo yesimo kunye namandla abo.
12. Iziganeko kunye nengxelo yokuKhumbula (ayiboneleli ngolwazi malunga nezixhobo zonyango ezisandul 'ukuphuhliswa kunye eziyilwe): uluhlu lweziganeko ezimbi okanye iziganeko ezinxulumene nokusetyenziswa kwesixhobo, kunye nesalathiso sexesha apho ezi ziganeko zenzeka, ukuba kukho zininzi kakhulu iziganeko ezibi, kusenokuba yimfuneko ukuba Iindidi zeziganeko Ukubonelela ngoshwankathelo olufutshane kwaye ubonise inani lilonke leziganeko ezixeliweyo kuhlobo ngalunye A uluhlu lwezimvo kunye/okanye izaziso ezichazayo kwimarike isixhobo zonyango kunye nenkcazo yeziganeko, iindlela zokuhlangabezana nazo kunye nezomenzi kwimeko nganye Isisombululo sichaza uhlalutyo kunye/okanye amanyathelo okulungisa ekufuneka athatyathwe ekuphenduleni kwezi meko 13. Uluhlu lwemigangatho ehambelana nayo isixhobo sonyango (kunye nolwazi olufanelekileyo)
14. Iimfuno ngokubanzi, iimfuno zokuleyibhela kunye noLwazi olufunwa ngamaxwebhu okusebenza (emva koku kubhekiselwa kuzo njengeemfuno ngokubanzi)
15. Amaxwebhu aseka iimfuno zeempawu zobugcisa bezixhobo zonyango 16. Iingxelo zeemvavanyo zobugcisa ezenziwe ukubonisa ukuthotyelwa kweemfuno eziqhelekileyo.
17. Iiprotokholi zezifundo (uvavanyo) zokuvavanya iziphumo zebhayoloji zezixhobo zonyango, Iinjongo zokubonisa ukuthotyelwa kweemfuno jikelele
18. Ubungqina bezonyango bunika ingxelo malunga nokusebenza kunye nokhuseleko lwezixhobo zonyango
19. Iingxelo zohlalutyo lomngcipheko
20. Idatha yeziyobisi kwizithako zesixhobo sonyango (ukwakheka kweziyobisi, ubungakanani, iziyobisi kunye nedatha yokuhambelana nesixhobo sonyango, Ukubhaliswa kwemveliso yechiza kwilizwe elenziwayo)
21. Idatha yoKhuseleko lwendalo
22. Idatha yenkqubo yokubulala inzala, kubandakanywa ukuqinisekiswa kwenkqubo, iziphumo zovavanyo lwe-microbiological (inqanaba le-bioburden), i-pyrogenicity, i-sterility (ukuba kuyimfuneko), kunye nemiyalelo yendlela yokuvavanya kunye nokupakishwa kweNgcaciso kwidatha yokuqinisekisa (imveliso engcolileyo)
23. Ulwazi oluthe ngqo lwesoftware (ukuba lukhona): Ulwazi lomvelisi malunga nokuqinisekiswa kwesoftware
24. Ingxelo yokufunda ngozinzo - kunye nenguqulelo yesiRashiya eyiyo yeziphumo zovavanyo kunye nezigqibo zeemveliso ezinobomi beshelufu
25. Ukusetyenziswa kumazwe avunyiweyo Amaxwebhu okusebenza okanye imiyalelo yokusetyenziswa kwesixhobo sonyango ngolwimi lwesizwe (ukuba kuyimfuneko) nakwisiRashiya.
26. Iincwadana zenkonzo (kwimeko yamacandelo ezixhobo zonyango) - ngokungabikho kwedatha kumaxwebhu okusebenza
27. Iingxelo zokuhlolwa kwemveliso 28. Izicwangciso zokuqokelela kunye nohlalutyo lwedatha malunga nokhuseleko kunye nokusebenza kakuhle kwezixhobo zonyango kwisigaba sokuthengisa