{"id":575,"date":"2018-04-01T10:33:39","date_gmt":"2018-04-01T10:33:39","guid":{"rendered":"http:\/\/bizlawyer.com.vn\/huong-dan-cua-bo-y-te-ve-quan-ly-trang-thiet-bi-y-te"},"modified":"2018-04-01T10:33:39","modified_gmt":"2018-04-01T10:33:39","slug":"huong-dan-cua-bo-y-te-ve-quan-ly-trang-thiet-bi-y-te","status":"publish","type":"post","link":"https:\/\/bizlawyer.vn\/vi\/huong-dan-cua-bo-y-te-ve-quan-ly-trang-thiet-bi-y-te","title":{"rendered":"H\u01b0\u1edbng d\u1eabn c\u1ee7a B\u1ed9 Y t\u1ebf v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-size:14px;\"><span style=\"line-height:2;\">Ng\u00e0y 15\/12\/2017 B\u1ed9 Y t\u1ebf \u0111\u00e3 ban h\u00e0nh Th\u00f4ng t\u01b0 s\u1ed1 46\/2017\/TT-BYT quy \u0111\u1ecbnh chi ti\u1ebft thi h\u00e0nh m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf. Th\u00f4ng t\u01b0 n\u00e0y s\u1ebd c\u00f3 hi\u1ec7u l\u1ef1c v\u00e0o ng\u00e0y 01\/02\/2018.&nbsp;<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size:14px;\"><span style=\"line-height:2;\">Vi\u1ec7c ra \u0111\u1eddi c\u1ee7a Th\u00f4ng t\u01b0 s\u1ed1: 116\/2017\/TT-BTC l\u00e0 \u0111i\u1ec1u r\u1ea5t c\u1ea7n thi\u1ebft \u0111\u1ed1i v\u1edbi c\u00e1c t\u1ed5 ch\u1ee9c thu\u1ed9c l\u0129nh v\u1ef1c y t\u1ebf c\u00f3 c\u01a1 s\u1edf \u0111\u1ec3 tham chi\u1ebfu v\u00e0 th\u1ef1c hi\u1ec7n vi\u1ec7c s\u1eed d\u1ee5ng, qu\u1ea3n l\u00fd c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng. Th\u00f4ng t\u01b0 c\u00f3 m\u1ed9t s\u1ed1 \u0111i\u1ec3m n\u1ed5i b\u1eadt c\u00f3 th\u1ec3 k\u1ec3 t\u1edbi nh\u01b0 sau:&nbsp;<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size:14px;\"><span style=\"line-height:2;\">Quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 v\u1ec1 c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c mi\u1ec5n cung c\u1ea5p b\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u th\u1eed l\u00e2m s\u00e0ng v\u00e0 k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u th\u1eed l\u00e2m s\u00e0ng khi th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m: Trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u thu\u1ed9c lo\u1ea1i C, D c\u00f3 x\u00e2m nh\u1eadp c\u01a1 th\u1ec3 ng\u01b0\u1eddi quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y; Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u00e0 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc ho\u1eb7c t\u1ed5 ch\u1ee9c thu\u1ed9c danh s\u00e1ch quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y; Tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c mi\u1ec5n gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m nghi\u1ec7m \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro khi th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh; Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro thu\u1ed9c lo\u1ea1i C, D \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u00e0 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc ho\u1eb7c t\u1ed5 ch\u1ee9c thu\u1ed9c danh s\u00e1ch quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y. B\u00ean c\u1ea1nh &nbsp;\u0111\u00f3, danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D \u0111\u01b0\u1ee3c mua, b\u00e1n nh\u01b0 c\u00e1c h\u00e0ng h\u00f3a th\u00f4ng th\u01b0\u1eddng g\u1ed3m: Danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D \u0111\u01b0\u1ee3c mua, b\u00e1n nh\u01b0 c\u00e1c h\u00e0ng h\u00f3a th\u00f4ng th\u01b0\u1eddng quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c III k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y; C\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb thu\u1ed9c danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D \u0111\u01b0\u1ee3c mua, b\u00e1n nh\u01b0 c\u00e1c h\u00e0ng h\u00f3a th\u00f4ng th\u01b0\u1eddng kh\u00f4ng ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size:14px;\"><span style=\"line-height:2;\">B\u00ean c\u1ea1nh \u0111\u00f3, Th\u00f4ng t\u01b0 c\u0169ng quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c h\u01b0\u1edbng d\u1eabn c\u00e1ch tr\u00ecnh b\u00e0y t\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt nh\u01b0 sau: M\u00f4 t\u1ea3 nguy\u00ean l\u00fd ho\u1ea1t \u0111\u1ed9ng v\u00e0 t\u00ednh n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb, ph\u1ea3i n\u00eau \u0111\u1ea7y \u0111\u1ee7 t\u00ean ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf, ti\u00eau chu\u1ea9n qu\u1ed1c gia, quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia, ti\u00eau chu\u1ea9n c\u01a1 s\u1edf \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 s\u1ea3n xu\u1ea5t v\u00e0 l\u00e0m c\u0103n c\u1ee9 \u0111\u1ec3 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3, an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf; \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p s\u1eed d\u1ee5ng ti\u00eau chu\u1ea9n c\u01a1 s\u1edf \u0111\u1ec3 s\u1ea3n xu\u1ea5t v\u00e0 l\u00e0m c\u0103n c\u1ee9 \u0111\u1ec3 ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3, an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf th\u00ec ti\u00eau chu\u1ea9n c\u01a1 s\u1edf ph\u1ea3i \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh t\u1ea1i Th\u00f4ng t\u01b0 s\u1ed1 21\/2007\/TT-BKHCN ng\u00e0y 28\/9\/2007 c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7 h\u01b0\u1edbng d\u1eabn vi\u1ec7c x\u00e2y d\u1ef1ng v\u00e0 \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n; Tr\u01b0\u1eddng h\u1ee3p s\u1eed d\u1ee5ng ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf th\u00ec ph\u1ea3i ghi r\u00f5 ngu\u1ed3n tra c\u1ee9u. B\u00ean c\u1ea1nh \u0111\u00f3, Th\u00f4ng t\u01b0 c\u0169ng h\u01b0\u1edbng d\u1eabn c\u00e1ch tr\u00ecnh b\u00e0y c\u1ee5m t\u1eeb ti\u1ebfng Vi\u1ec7t \u0111\u01b0\u1ee3c d\u1ecbch sang ti\u1ebfng Anh \u0111\u1ed1i v\u1edbi m\u1eabu gi\u1ea5y \u1ee7y quy\u1ec1n. Theo \u0111\u00f3, vi\u1ec7c tr\u00ecnh b\u00e0y c\u1ee5m t\u1eeb ti\u1ebfng Vi\u1ec7t \u0111\u01b0\u1ee3c d\u1ecbch sang ti\u1ebfng Anh \u0111\u1ed1i v\u1edbi m\u1eabu gi\u1ea5y \u1ee7y quy\u1ec1n quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y.<\/span><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size:14px;\"><span style=\"line-height:2;\">N\u1ed9i dung c\u1ee7a Th\u00f4ng t\u01b0 s\u1ed1 46\/2017\/TT-BYT v\u1edbi nh\u1eefng quy \u0111\u1ecbnh m\u1edbi v\u00e0 chi ti\u1ebft h\u01a1n c\u00e1c v\u0103n b\u1ea3n h\u01b0\u1edbng d\u1eabn tr\u01b0\u1edbc \u0111\u00f3 l\u00e0 m\u1ed9t b\u01b0\u1edbc ti\u1ebfn mang t\u00ednh \u0111\u1ed9t ph\u00e1 v\u00e0 r\u1ea5t c\u1ea7n thi\u1ebft, l\u00e0 c\u01a1 s\u1edf \u0111\u1ea3m b\u1ea3o t\u1ed1t nh\u1ea5t cho s\u1ef1 v\u1eadn h\u00e0nh c\u1ee7a l\u0129nh v\u1ef1c Y t\u1ebf, \u0111\u1ea3m b\u1ea3o quy\u1ec1n, l\u1ee3i \u00edch c\u0169ng nh\u01b0 ngh\u0129a v\u1ee5 c\u1ee7a c\u00e1c c\u00e1 nh\u00e2n ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c n\u00e0y.&nbsp;<\/span><\/span><br \/>  &nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ng\u00e0y 15\/12\/2017 B\u1ed9 Y t\u1ebf \u0111\u00e3 ban h\u00e0nh Th\u00f4ng t\u01b0 s\u1ed1 46\/2017\/TT-BYT quy \u0111\u1ecbnh chi ti\u1ebft thi h\u00e0nh m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf. Th\u00f4ng t\u01b0 n\u00e0y s\u1ebd c\u00f3 hi\u1ec7u l\u1ef1c v\u00e0o ng\u00e0y 01\/02\/2018.&nbsp; Vi\u1ec7c ra [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-575","post","type-post","status-publish","format-standard","hentry","category-bai-viet"],"_links":{"self":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/575","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/comments?post=575"}],"version-history":[{"count":0,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/575\/revisions"}],"wp:attachment":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/media?parent=575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/categories?post=575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/tags?post=575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}