{"id":14708,"date":"2021-09-30T06:56:41","date_gmt":"2021-09-30T06:56:41","guid":{"rendered":"https:\/\/bizlawyer.vn\/medical-equipment-is-quickly-issued-with-a-free-registration-number"},"modified":"2021-09-30T07:01:47","modified_gmt":"2021-09-30T07:01:47","slug":"trang-thiet-bi-y-te-duoc-cap-nhanh-so-luu-hanh","status":"publish","type":"post","link":"https:\/\/bizlawyer.vn\/vi\/trang-thiet-bi-y-te-duoc-cap-nhanh-so-luu-hanh","title":{"rendered":"Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh"},"content":{"rendered":"

Ng\u00e0y 16\/9\/2021, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ban h\u00e0nh Th\u00f4ng t\u01b0 s\u1ed1 13\/2021\/TT-BYT quy \u0111\u1ecbnh c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ee5c v\u1ee5 ph\u00f2ng, ch\u1ed1ng d\u1ecbch COVID-19 trong tr\u01b0\u1eddng h\u1ee3p c\u1ea5p b\u00e1ch.<\/p>\n

Theo \u0111\u00f3, trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng h\u00ecnh th\u1ee9c c\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh n\u1ebfu \u0111\u00e1p \u1ee9ng \u0111\u1ed3ng th\u1eddi c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau \u0111\u00e2y:<\/strong><\/span><\/p>\n

L\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ee5c v\u1ee5 ph\u00f2ng, ch\u1ed1ng d\u1ecbch covid-19 c\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh thu\u1ed9c danh m\u1ee5c quy \u0111\u1ecbnh, bao g\u1ed3m: M\u00e1y t\u00e1ch chi\u1ebft; M\u00e1y PCR, H\u00f3a ch\u1ea5t (sinh ph\u1ea9m) ch\u1ea1y m\u00e1y PCR x\u00e9t nghi\u1ec7m SARS-CoV-2; Test k\u00edt x\u00e9t nghi\u1ec7m nhanh kh\u00e1ng nguy\u00ean\/ kh\u00e1ng th\u1ec3 kh\u00e1ng SARS-CoV-2; M\u00e1y th\u1edf ch\u1ee9c n\u0103ng cao, m\u00e1y th\u1edf x\u00e2m nh\u1eadp v\u00e0 kh\u00f4ng x\u00e2m nh\u1eadp, m\u00e1y th\u1edf kh\u00f4ng x\u00e2m nh\u1eadp, m\u00e1y oxy d\u00f2ng cao, m\u00e1y th\u1edf x\u00e1ch tay; M\u00e1y l\u1ecdc m\u00e1u li\u00ean t\u1ee5c; M\u00e1y X-Quang di \u0111\u1ed9ng; M\u00e1y si\u00eau \u00e2m Doppler m\u00e0u \u2265 3 \u0111\u1ea7u d\u00f2; M\u00e1y \u0111o kh\u00ed m\u00e1u (\u0111o \u0111\u01b0\u1ee3c \u0111i\u1ec7n gi\u1ea3i, lactat, hematocrite); M\u00e1y theo d\u00f5i b\u1ec7nh nh\u00e2n \u2265 5 th\u00f4ng s\u1ed1; B\u01a1m ti\u00eam \u0111i\u1ec7n; M\u00e1y truy\u1ec1n d\u1ecbch; M\u00e1y ph\u00e1 rung tim c\u00f3 t\u1ea1o nh\u1ecbp; M\u00e1y \u0111i\u1ec7n tim \u2265 6 k\u00eanh; M\u00e1y si\u00eau \u00e2m x\u00e1ch tay; M\u00e1y \u0111o th\u1eddi gian \u0111\u00f4ng m\u00e1u; M\u00e1y \u0111o huy\u1ebft \u0111\u1ed9ng.<\/em><\/p>\n

Thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:<\/strong><\/span><\/p>\n

1. \u0110\u00e3 \u0111\u01b0\u1ee3c m\u1ed9t trong c\u00e1c t\u1ed5 ch\u1ee9c sau cho ph\u00e9p l\u01b0u h\u00e0nh ho\u1eb7c s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p: C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) – M\u1ef9; C\u1ee5c Qu\u1ea3n l\u00fd h\u00e0ng h\u00f3a tr\u1ecb li\u1ec7u (TGA) – \u00dac; C\u01a1 quan qu\u1ea3n l\u00fd y t\u1ebf Canada (Health Canada); B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n (MHLW) ho\u1eb7c C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (PMDA) – Nh\u1eadt B\u1ea3n;
\n2. \u0110\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a c\u00e1c n\u01b0\u1edbc thu\u1ed9c khu v\u1ef1c Ch\u00e2u u quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c 2 k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y cho ph\u00e9p l\u01b0u h\u00e0nh, s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p;
\n3. Thu\u1ed9c danh m\u1ee5c s\u1ea3n ph\u1ea9m x\u00e9t nghi\u1ec7m SARS-CoV-2 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p do T\u1ed5 ch\u1ee9c Y t\u1ebf th\u1ebf gi\u1edbi (WHO) c\u00f4ng b\u1ed1 tr\u00ean trang web t\u1ea1i \u0111\u1ecba ch\u1ec9 https:\/\/extranet.who.int (Coronavirus disease (COVID-19) Pandemic – Emergency Use Listing Procedure (EUL) open for IVDs | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Imm unization Devices, Vector Control);
\n4. Thu\u1ed9c danh m\u1ee5c c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ed5 bi\u1ebfn \u0111\u1ec3 x\u00e9t nghi\u1ec7m SARS-CoV-2 do \u1ee6y ban an ninh y t\u1ebf c\u1ee7a Ch\u00e2u u ban h\u00e0nh (Health Security Committee – EUHSC) c\u00f4ng b\u1ed1 tr\u00ean trang web t\u1ea1i \u0111\u1ecba ch\u1ec9 https:\/\/ec.europa.eu (Technical working group on COVID-19 diagnostic tests | Public Health (europa.eu);
\n5. \u0110\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo h\u00ecnh th\u1ee9c th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Vi\u1ec7t Nam tr\u01b0\u1edbc ng\u00e0y Th\u00f4ng t\u01b0 n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c (ng\u00e0y 16\/9\/2021);
\n6. \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc theo h\u00ecnh th\u1ee9c chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p (1), (2), (3), (4), (5) n\u00eau tr\u00ean;
\n7. \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc theo h\u00ecnh th\u1ee9c gia c\u00f4ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p (1), (2), (3), (4), (5) n\u00eau tr\u00ean.<\/p>\n

Th\u00f4ng t\u01b0 n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y 16\/9\/2021.<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Ng\u00e0y 16\/9\/2021, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ban h\u00e0nh Th\u00f4ng t\u01b0 s\u1ed1 13\/2021\/TT-BYT quy \u0111\u1ecbnh c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ee5c v\u1ee5 ph\u00f2ng, ch\u1ed1ng d\u1ecbch COVID-19 trong tr\u01b0\u1eddng h\u1ee3p c\u1ea5p b\u00e1ch. Theo \u0111\u00f3, trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng h\u00ecnh th\u1ee9c c\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh n\u1ebfu […]<\/p>\n","protected":false},"author":3,"featured_media":14704,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14708","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bai-viet"],"_links":{"self":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/14708","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/comments?post=14708"}],"version-history":[{"count":0,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/posts\/14708\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/media\/14704"}],"wp:attachment":[{"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/media?parent=14708"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/categories?post=14708"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bizlawyer.vn\/vi\/wp-json\/wp\/v2\/tags?post=14708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}