Hoʻopaʻa inoa ʻana i nā mea lapaʻau Lūkia - Russia a me CIS Certification introduction to Russian Medical Device Registration
ʻO ka Palapala Hoʻopaʻa Lapaʻau Lapaʻau Lūkini, i hoʻopuka ʻia e ka Russian Federal Service for Health Care and Social Development Supervision (i kapa ʻia ʻo ka Russian Health Supervision Service), e hōʻoia ana ua holo pono nā mea lapaʻau a i ʻole nā mea lapaʻau i nā hoʻokolohua o nā hui Lūkini, ua hoʻopaʻa inoa ʻia a ʻae ʻia e lawe mai, hana, kūʻai aku a kūʻai aku ma Rusia. Palapala no ka hoʻohana ʻana ma Rusia. ʻO nā huahana lāʻau lapaʻau āpau, inā i loko a i lawe ʻia mai paha i Rusia, ʻoiai lākou e hoʻohana ʻia no ka pale ʻana, ka maʻi ʻana, ka mālama ʻana, ka hoʻoponopono hou ʻana, ka noiʻi olakino, ka hoʻololi ʻana a me ka hoʻololi ʻana i nā ʻiʻo a me nā kino kanaka, ka hoʻomaikaʻi ʻana a i ʻole ka uku ʻana i nā hana physiological i pōʻino a nalowale, etc. . Inā hoʻohanaʻia ia no ka mea maʻi i hoʻopilikino ponoʻia i ka lāʻau lapaʻau, pono ka huahana e hōʻike i nā koi kūikawā o ka limahana lapaʻau a me ka palapala hōʻoia i hoʻohana ponoʻia no kēlā me kēia ma mua o ka'āina. ʻAʻole pono kēlā huahana i kahi palapala hoʻopaʻa inoa olakino. ʻO ka lawe ʻana aku i nā mea lapaʻau i Rūsia e koi i kahi palapala hoʻopaʻa inoa olakino a me kahi palapala GOST R o ka conformity palapala i hoʻopuka ʻia e ka Russian Medical and Health Supervision Bureau.
ʻO ka hoʻokaʻawale ʻana o nā mea lapaʻau Lūkini
Hoʻokaʻawale ʻo Rūsia i nā huahana lāʻau lapaʻau i ʻehā mau papa e like me ka pilikia o ka huahana: Papa I - huahana papa haʻahaʻa haʻahaʻa Class IIa - huahana papa kūlana kiʻekiʻe Class IIb - huahana papa kiʻekiʻe Class III - huahana papa kiʻekiʻe loa Ke noi nei i kahi lāʻau lapaʻau. palapala hoʻopaʻa inoa, e like me nā lula hoʻopaʻa inoa lāʻau hou loa, koi ʻia nā hoʻokolohua lapaʻau a me nā ʻenehana no nā ʻano huahana āpau.
Ka Pono o ka Palapala Hoʻopaʻa Lapaʻau Lapaʻau Lūkini
ʻO ka palapala hoʻopaʻa inoa olakino he palapala kūpono lōʻihi; GOST R conformity declaration palapala: ʻo ka manawa kūpono loa he 3 mau makahiki (ma hope o ka loaʻa ʻana o ka palapala hoʻopaʻa inoa olakino, hiki iā ʻoe ke noi no GOST R, a hiki iā ʻoe ke noi hou ma hope o ka pau ʻana)
Laʻana palapala hoʻopaʻa inoa lāʻau lapaʻau Lūkini
ʻO ka palapala hoʻopaʻa inoa olakino he palapala kūpono lōʻihi; GOST R conformity declaration palapala: ʻo ka manawa kūpono loa he 3 mau makahiki (ma hope o ka loaʻa ʻana o ka palapala hoʻopaʻa inoa olakino, hiki iā ʻoe ke noi no GOST R, a hiki iā ʻoe ke noi hou ma hope o ka pau ʻana)
