Kunyoreswa kweRussia Medical Device - Russia uye CIS Certification Sumo kuRussia Medical Chishandiso Kunyoreswa.
Chitupa cheRussia Medical Device Registration Certificate, chakapihwa neRussian Federal Service yeHealth Care uye Social Development Supervision (inonzi Russian Health Supervision Service), inosimbisa kuti michina yekurapa kana zvigadzirwa zvekurapa zvakabudirira bvunzo dzemasangano eRussia, zvakanyoreswa uye. inobvumirwa kupinza, kugadzira, kutengesa uye kutengesa muRussia.Chitupa chekushandisa muRussia.Zvese zvigadzirwa zvemidziyo yekurapa, ingave yepamba kana kunze kwenyika muRussia, chero bedzi zvichishandiswa kudzivirira, kuongororwa, kurapwa, kudzoreredza, kutsvagisa kwekurapa, kutsiva uye kugadziridzwa kwematishu emunhu uye nhengo, kuvandudza kana kubhadharwa kweakakuvadzwa uye akarasika emuviri mabasa, nezvimwe, nezvimwe. Zvigadzirwa zvinotarisirwa zviri pasi pechitupa chekuRussia chekunyoreswa kwekurapa.Kana ichishandiswa kumunhu wemurwere akagadziridzwa chigadzirwa chekurapa, chigadzirwa chinoda kuratidza zvakakosha zvinodiwa nemushandi wekurapa uye chitupa chinonyatso shandiswa kumunhu kwete nyika.Chigadzirwa chakadaro hachidi gwaro rekunyoresa rekurapa.Kutengeswa kunze kwemidziyo yekurapa kuRussia kunoda chitupa chekunyoresa kurapwa uye GOST R chiziviso chekuenderana chitupa chakapihwa neRussia Medical uye Health Supervision Bureau.
Russian medical device classification
Russia inokamura zvigadzirwa zvemidziyo yekurapa kuita makirasi mana zvichienderana nenjodzi inogona kuitika yechigadzirwa: Kirasi I - yakaderera njodzi kirasi chigadzirwa Kirasi IIa - yepakati njodzi kirasi chigadzirwa Kirasi IIb - yakanyanya njodzi kirasi chigadzirwa Kirasi III - yakanyanya njodzi kirasi chigadzirwa Parizvino kunyorera kurapwa. chitupa chekunyoresa, zvinoenderana neazvino mirairo yekunyoresa yekurapa, kiriniki uye tekinoroji bvunzo inodiwa kune ese marudzi ezvigadzirwa.
Kutendeseka kweRussia Medical Device Registration Certificate
Chitupa chekunyoresa kuchipatara chitupa chenguva refu;GOST R conformity declaration certificate: iyo yakanyanya kutendeseka nguva ndeye 3 makore (mushure mekuwana gwaro rekunyoresa rekurapa, unogona kunyorera GOST R, uye iwe unogona kunyorera zvakare mushure mekupera)
Chiratidzo chekunyoresa chitupa cheRussian medical device sample
Chitupa chekunyoresa kuchipatara chitupa chenguva refu;GOST R conformity declaration certificate: iyo yakanyanya kutendeseka nguva ndeye 3 makore (mushure mekuwana gwaro rekunyoresa rekurapa, unogona kunyorera GOST R, uye iwe unogona kunyorera zvakare mushure mekupera)
