Russian Medical Device Kunyoreswa - Russia uye CIS Certification Sumo kuRussia Medical Chishandiso Kunyoreswa.
Iyo Russian Medical Device Registration Certificate, yakapihwa neRussia Federal Service yeHealth Care uye Social Development Supervision (inonzi Russian Health Supervision Service), inosimbisa kuti michina yekurapa kana zvigadzirwa zvekurapa zvakabudirira kupasa bvunzo dzeRussia masangano, akanyoreswa uye. inobvumirwa kupinza, kugadzira, kutengesa uye kutengesa muRussia. Chitupa chekushandisa muRussia. Zvese zvigadzirwa zvemidziyo yekurapa, ingave yekumba kana kuendeswa kunze kwenyika muRussia, chero bedzi zvichishandiswa kudzivirira, kuongororwa, kurapwa, kugadzirisa, kutsvagisa kwekurapa, kutsiva uye kugadziridzwa kwematishu emunhu uye nhengo, kuvandudza kana kubhadharwa kweakakuvadzwa uye akarasika mabasa emuviri, nezvimwe, nezvimwe. Zvigadzirwa zvinotarisirwa zviri pasi pechitupa chekuRussia chekunyoresa. Kana ichishandiswa kumunhu wemurwere akagadziridzwa chigadzirwa chekurapa, chigadzirwa chinoda kuratidza zvakakosha zvinodiwa nemushandi wekurapa uye chitupa chinonyatso shandiswa kumunhu kwete nyika. Chigadzirwa chakadaro hachidi chitupa chekunyoresa chekurapa. Kutumirwa kwemidziyo yekurapa kuRussia kunoda chitupa chekunyoresa kuchipatara uye GOST R chiziviso chekuenderana chitupa chakapihwa neRussia Medical and 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)
