Kuyambira pa Januware 1, 2022, zida zonse zatsopano zamankhwala zomwe zimalowa m'maiko a Eurasian Economic Union monga Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, ndi zina zotero ziyenera kulembetsedwa motsatira malamulo a Union EAC MDR.Kenako vomerezani chikalata cholembetsa kudziko limodzi.Zida zamankhwala zomwe zidalembetsedwa ku Russian Federation zitha kupitiliza kugwiritsidwa ntchito, kapena satifiketi yolembetsedwa ikhoza kusinthidwa mpaka 2027.
EAC MDR Product Classification
Malingana ndi milingo yosiyanasiyana ya chiopsezo, EAC MDR ikhoza kugawidwa m'kalasi I, Class IIa, Class IIb, Class III, yomwe Gulu la III lili ndi chiopsezo chachikulu, chofanana ndi European Union.Kukwera kwachiwopsezo, kumakweza njira zolembera ndi zofunikira.
EAC MDR Certification Njira
1. Kutsimikiza kwa mlingo wa chiopsezo ndi mtundu wa nomenclature kuti agwiritse ntchito 2. Kudziwitsa zolemba zolemba 3. Kusonkhanitsa umboni wa chitetezo ndi mphamvu 4. Kusankhidwa kwa chiwerengero cha zolemba ndi chizindikiritso
5. Lipirani msonkho wa kasitomu
6. Tumizani zikalata
7. Kuwunika kopanga zida zamankhwala, ndi zina.
8. Ndondomeko Yovomerezeka
9. Kulembetsa kwa chipangizo chachipatala
Chidziwitso cha Chitsimikizo cha EAC MDR
Mndandanda wazinthu zotsatirazi ndizosankha, kutengera kuchuluka kwa chiwopsezo cha chinthucho kuti zitsimikizire ngati ziyenera kuperekedwa.
1. Lemberani mu fomu yomwe yafotokozedwa mu Zowonjezera
2 ndi 3 ya "Kulembetsa ndi Malamulo Aukadaulo a Chitetezo, Ubwino ndi Kuchita Bwino kwa Zida Zachipatala"
3. Kalata yovomerezeka yoyimira zofuna za wopanga polembetsa
4. Chikalata cha satifiketi ya kasamalidwe kabwino ka wopanga zida zachipatala (ISO 13485 kapena milingo yoyenera yachigawo kapena dziko lonse la mayiko omwe ali membala)
5. Chidziwitso chokhudzana ndi chitetezo cha chipangizo chachipatala ndi kagwiritsidwe ntchito kake kapena chikalata chofanana
6. Satifiketi yolembetsa yoperekedwa ndi dziko lopanga ( Copy of satifiketi yogulitsa kwaulere, satifiketi yotumiza kunja (kupatula zida zamankhwala zomwe zidayamba kupangidwa m'gawo la Member State)) ndikumasuliridwa ku Russian
7. Kope la zikalata zotsimikizira kulembetsa kumayiko ena
8. Satifiketi ya chipangizo chachipatala chofotokoza Kuchuluka kwa chipangizo chachipatala, kagwiritsidwe ntchito, mawonekedwe achidule, mitundu ndi zowonjezera (mawonekedwe)
9. Kuyika ndi kulongedza deta (mapangidwe amtundu wathunthu ndi zolemba, zolembedwa mu Chirasha ndi zilankhulo zovomerezeka za mayiko mamembala)
10. Zambiri zachitukuko ndi kupanga: zojambula zopanga, Njira zazikulu zopangira, kuyika, kuyesa ndi njira zomaliza zotulutsira zinthu.
11. Zambiri za wopanga: dzina, mtundu wa zochitika, adilesi yovomerezeka, mawonekedwe a umwini, kapangidwe ka oyang'anira, mndandanda wamadipatimenti ndi mabungwe, ndi kufotokozera za udindo wawo ndi mphamvu zawo.
12. Lipoti la Zochitika ndi Kukumbukira (sikumapereka chidziwitso pazipangizo zamankhwala zomwe zangopangidwa kumene): mndandanda wa zochitika zovuta kapena zochitika zokhudzana ndi kugwiritsidwa ntchito kwa chipangizocho, ndi chisonyezero cha nthawi yomwe izi zinachitika, ngati ndizovuta zambiri, zingakhale zofunikira kuti Mitundu ya Zochitika Perekani mwachidule ndikuwonetsa chiwerengero cha zochitika zomwe zafotokozedwa pamtundu uliwonse A mndandanda wa ndemanga ndi / kapena zidziwitso zofotokozera za msika wa zipangizo zachipatala ndi kufotokozera zochitikazo, Njira zothanirana ndi iwo ndi opanga nthawi iliyonse Yankho limafotokoza kusanthula ndi/kapena zowongolera zomwe zikuyenera kuchitika potsatira izi 13. Mndandanda wa miyezo yomwe chipangizo chachipatala chimagwirizana (ndi chidziwitso chofunikira)
14. Zofunikira zonse, zofunikira zolembera ndi Zomwe zimafunidwa ndi zikalata zogwirira ntchito (zomwe zimadziwika kuti - zofunikira zonse)
15. Zolemba zokhazikitsa zofunikira zaukadaulo wa zida zamankhwala 16. Malipoti a mayeso aumisiri omwe amachitidwa kuti awonetse kutsata zofunikira zonse.
17. Ndondomeko za maphunziro (mayeso) kuti awone zotsatira za chilengedwe cha zipangizo zamankhwala, Cholinga chosonyeza kutsata zofunikira
18. Umboni wachipatala umapereka malipoti okhudza mphamvu ndi chitetezo cha zipangizo zachipatala
19. Malipoti akuwunika zoopsa
20. Deta ya mankhwala muzosakaniza za zida zachipatala (zopangidwa ndi mankhwala, kuchuluka kwake, deta yogwirizana ndi mankhwala ndi zida zamankhwala, Kulembetsa kwa mankhwala m'dziko lomwe amapangidwira)
21. Deta ya Biosafety
22. Dongosolo la njira yotsekera, kuphatikiza kutsimikizika kwa ndondomeko, zotsatira za mayeso a microbiological (mulingo wa bioburden), pyrogenicity, sterility (ngati kuli kofunikira), ndi malangizo a njira yoyesera ndi kulongedza Zambiri pa data yotsimikizira (zosabala)
23. Zambiri zamapulogalamu (ngati zilipo): Zambiri za wopanga pazotsimikizira mapulogalamu
24. Lipoti la kafukufuku wokhazikika - ndi zomasulira zenizeni za Chirasha pazotsatira zoyeserera ndi zomaliza za zinthu zomwe zili ndi alumali moyo
25. Kugwiritsa ntchito m'mayiko ovomerezeka Zikalata zogwirira ntchito kapena malangizo ogwiritsira ntchito chipangizo chachipatala m'chinenero cha dziko (ngati kuli kofunikira) komanso mu Russian
26. Zolemba zautumiki (pazigawo za zida zamankhwala) - ngati palibe deta muzolemba zogwirira ntchito
27. Malipoti oyendera zopanga 28. Mapulani a kusonkhanitsa ndi kusanthula deta pa chitetezo ndi mphamvu ya zipangizo zachipatala pambuyo pa malonda