<div id="pf1" class="pf w0 h0" data-page-no="1"><div class="pc pc1 w0 h0"><img class="bi x0 y0 w1 h1" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg1.png"><div class="t m0 x1 h2 y1 ff1 fs0 fc0 sc0 ls0 ws0">ABC<span class="fs1 ws1"> </span></div><div class="t m0 x2 h3 y2 ff1 fs2 fc0 sc0 ls0 ws1">De </div><div class="t m0 x3 h3 y3 ff1 fs2 fc0 sc0 ls0 ws1">Dispositivos Médic<span class="blank _0"></span>os</div><div class="t m1 x4 h4 y4 ff2 fs3 fc1 sc0 ls0">L</div><div class="t m2 x4 h5 y5 ff2 fs4 fc1 sc0 ls0">i</div><div class="t m3 x5 h6 y6 ff2 fs5 fc1 sc0 ls0">b</div><div class="t m4 x5 h7 y7 ff2 fs6 fc1 sc0 ls0">e</div><div class="t m5 x6 h8 y8 ff2 fs7 fc1 sc0 ls0">r</div><div class="t m6 x6 h9 y9 ff2 fs8 fc1 sc0 ls0">t</div><div class="t m7 x6 ha ya ff2 fs9 fc1 sc0 ls0">a</div><div class="t m8 x7 hb yb ff2 fsa fc1 sc0 ls0">y</div><div class="t m9 x8 h8 yc ff2 fs7 fc1 sc0 ls0">O</div><div class="t ma x8 hc yd ff2 fsb fc1 sc0 ls0">r</div><div class="t mb x9 hd ye ff2 fsc fc1 sc0 ls0">d</div><div class="t mc x9 he yf ff2 fsd fc1 sc0 ls0">e</div><div class="t md xa h8 y10 ff2 fs7 fc1 sc0 ls0">n</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf2" class="pf w0 h0" data-page-no="2"><div class="pc pc2 w0 h0"><div class="t m0 xb hf y11 ff1 fse fc1 sc0 ls0 ws2">ABC <span class="blank _1"> </span>DE <span class="ff3">DISPOSITIVOS MÉDICOS</span></div><div class="t m0 xb hf y12 ff1 fse fc1 sc0 ls0 ws1">MINISTERIO DE SALUD <span class="blank _0"></span>Y PRO<span class="blank _0"></span>TECCIÓN SOCIAL </div><div class="t m0 xb hf y13 ff1 fse fc1 sc0 ls0 ws1">Instituto Nacional de <span class="blank _0"></span>Vigilancia de Medicamentos y Alimentos - INVIM<span class="blank _0"></span>A</div><div class="t m0 xb hf y14 ff1 fse fc1 sc0 ls0 ws1"> </div><div class="t m0 xb hf y15 ff1 fse fc1 sc0 ls0 ws1">Directora General </div><div class="t m0 xb h10 y16 ff4 fse fc1 sc0 ls0 ws1">Blanca Elvira Cajigas de Acosta</div><div class="t m0 xb hf y17 ff1 fse fc1 sc0 ls0 ws1">Director de Dispositivos Médicos y Otras <span class="blank _0"></span>T<span class="blank _0"></span>ecnologías con funciones de Director de </div><div class="t m0 xb hf y18 ff1 fse fc1 sc0 ls0 ws1">Operaciones Sanitarias </div><div class="t m0 xb h10 y19 ff4 fse fc1 sc0 ls0 ws1">Elkin Hernán O<span class="blank _1"> </span>tálvaro Cifuentes</div><div class="t m0 xb hf y1a ff1 fse fc1 sc0 ls0 ws1">Director de Medicamentos y Productos Biológicos </div><div class="t m0 xb h10 y1b ff4 fse fc1 sc0 ls0 ws1">Carlos Augusto Sanchez Estupiñan</div><div class="t m0 xb hf y1c ff1 fse fc1 sc0 ls0 ws1">Directora de Cosmétic<span class="blank _0"></span>os, Aseo, Plaguicidas y P<span class="blank _0"></span>roduc<span class="blank _1"> </span>tos de Higiene Doméstica </div><div class="t m0 xb h10 y1d ff4 fse fc1 sc0 ls0 ws1">Luz Helena F<span class="blank _0"></span>ranco Chaparro</div><div class="t m0 xb hf y1e ff1 fse fc1 sc0 ls0 ws1">Director de Alimentos y Bebidas </div><div class="t m0 xb h10 y1f ff4 fse fc1 sc0 ls0 ws1">Harry Alber<span class="blank _1"> </span>to Silva Llinas</div><div class="t m0 xb hf y20 ff1 fse fc1 sc0 ls0 ws1">Secretario General </div><div class="t m0 xb h10 y21 ff4 fse fc1 sc0 ls0 ws1">Luis Manuel Garavito\ue61fMedina</div><div class="t m0 xb hf y22 ff1 fse fc1 sc0 ls0 ws1">Directora de Responsabilidad Sanitaria </div><div class="t m0 xb h10 y23 ff4 fse fc1 sc0 ls0 ws1">Ruth Patricia Díaz</div><div class="t m0 xb hf y24 ff1 fse fc1 sc0 ls0 ws1">Jefe O\ue61fcina Asesora Jurídica </div><div class="t m0 xb h10 y25 ff4 fse fc1 sc0 ls0 ws1">Raúl Hernando Esteban García</div><div class="t m0 xb hf y26 ff1 fse fc1 sc0 ls0 ws1">Jefe O\ue61fcina de <span class="blank _0"></span>T<span class="blank _0"></span>ecnologías de la Información </div><div class="t m0 xb h10 y27 ff4 fse fc1 sc0 ls0 ws1">Ricardo Maldonado Rodriguez</div><div class="t m0 xb hf y28 ff1 fse fc1 sc0 ls0 ws1">Jefe O\ue61fcina Contr<span class="blank _0"></span>ol Interno </div><div class="t m0 xb h10 y29 ff4 fse fc1 sc0 ls0 ws1">Norma Constanza García Ramírez</div><div class="t m0 xb hf y2a ff1 fse fc1 sc0 ls0 ws1">O\ue61fcina de Comunicaciones </div><div class="t m0 xb h10 y2b ff4 fse fc1 sc0 ls0 ws1">Andrés Eduardo Mogollón Echev<span class="blank _0"></span>err<span class="blank _1"> </span>y</div><div class="t m0 xb hf y2c ff1 fse fc1 sc0 ls0 ws2">Revisión T<span class="blank _0"></span>écnica<span class="ws1"> </span></div><div class="t m0 xb h10 y2d ff4 fse fc1 sc0 ls0 ws1">Mukoil Romanos Zapata </div><div class="t m0 xb h10 y2e ff4 fse fc1 sc0 ls0 ws1">Sofía Ines Rivera Castro </div><div class="t m0 xb h10 y2f ff4 fse fc1 sc0 ls0 ws1">Carlos Ramírez Quiroga </div><div class="t m0 xb h10 y30 ff4 fse fc1 sc0 ls0 ws3">Zulma V<span class="blank _0"></span>albuena <span class="blank _1"> </span>Jiménez<span class="ws1"> </span></div><div class="t m0 xb h10 y31 ff4 fse fc1 sc0 ls0 ws1">Mabel Barbosa Romero </div><div class="t m0 xb h10 y32 ff4 fse fc1 sc0 ls0 ws4">Y<span class="blank _0"></span>ulied <span class="blank _1"> </span>Montaño Y<span class="blank _0"></span>aruro<span class="ws1"> </span></div><div class="t m0 xb h10 y33 ff4 fse fc1 sc0 ls0 ws1">Eleonora Celis Cañas </div><div class="t m0 xb h10 y34 ff4 fse fc1 sc0 ls0 ws1">Luis Eduardo Díaz </div><div class="t m0 xb h10 y35 ff4 fse fc1 sc0 ls0 ws1">Adriana Sacristán Celis</div><div class="t m0 xb hf y36 ff1 fse fc1 sc0 ls0 ws1">Diseño, Diagr<span class="blank _0"></span>amación e Impresión </div><div class="t m0 xb h10 y37 ff4 fse fc1 sc0 ls0 ws1">Imprenta Nacional </div><div class="t m0 xb h10 y38 ff4 fse fc1 sc0 ls0 ws1">Bogotá D.C. 2013</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf3" class="pf w0 h0" data-page-no="3"><div class="pc pc3 w0 h0"><img fetchpriority="low" loading="lazy" class="bi xb y39 w2 h11" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg3.png"><div class="t m0 xc h12 y3a ff5 fsf fc1 sc0 ls0 ws1"><span class="fc2 sc0">ABC </span><span class="fs10 ws5"><span class="fc2 sc0">dispositivos</span></span><span class="fc2 sc0"> </span><span class="fs10 ws5"><span class="fc2 sc0">médiC</span><span class="fc2 sc0">os</span></span></div><div class="t m0 xd h13 y3b ff1 fs11 fc1 sc0 ls0">5</div><div class="t me xe h14 y3c ff6 fs12 fc1 sc0 ls0"><span class="fc2 sc0">L</span></div><div class="t mf xe h15 y3d ff6 fs13 fc1 sc0 ls0"><span class="fc2 sc0">i</span></div><div class="t m10 xe h16 y3e ff6 fs14 fc1 sc0 ls0"><span class="fc2 sc0">b</span></div><div class="t m11 xe h17 y3f ff6 fs15 fc1 sc0 ls0"><span class="fc2 sc0">e</span></div><div class="t m12 xf h18 y40 ff6 fs16 fc1 sc0 ls0"><span class="fc2 sc0">r</span></div><div class="t m13 xf h19 y41 ff6 fs17 fc1 sc0 ls0"><span class="fc2 sc0">t</span></div><div class="t m14 xf h1a y42 ff6 fs18 fc1 sc0 ls0"><span class="fc2 sc0">a</span></div><div class="t m15 x10 h1b y43 ff6 fs19 fc1 sc0 ls0"><span class="fc2 sc0">y</span></div><div class="t m16 x10 h18 y40 ff6 fs16 fc1 sc0 ls0"><span class="fc2 sc0">O</span></div><div class="t m17 x11 h1c y44 ff6 fs1a fc1 sc0 ls0"><span class="fc2 sc0">r</span></div><div class="t m18 x11 h1d y45 ff6 fs1b fc1 sc0 ls0"><span class="fc2 sc0">d</span></div><div class="t m19 x11 h1e y46 ff6 fs1c fc1 sc0 ls0"><span class="fc2 sc0">e</span></div><div class="t m1a x11 h18 y47 ff6 fs16 fc1 sc0 ls0"><span class="fc2 sc0">n</span></div><div class="t m0 x12 h1f y48 ff7 fs1d fc0 sc0 ls3 ws6">C<span class="blank"> </span>o<span class="blank _0"></span>n<span class="blank _0"></span>t<span class="blank _0"></span>e<span class="blank _0"></span>nido</div><div class="t m0 xb h20 y49 ff1 fsf fc1 sc0 ls1 ws7">INTRODUC<span class="blank _0"></span>CIÓN<span class="blank"> </span><span class="ff4 ls2 ws8">......................................................................<span class="blank"> </span><span class="ls0 wsb"> 7</span></span></div><div class="t m0 xb h20 y4a ff1 fsf fc1 sc0 ls1 ws9">PRESENT<span class="blank _2"></span>A<span class="blank _0"></span>CIÓN<span class="ff4 ls2 wsc"> ......................................................................<span class="blank _3"> </span><span class="ls0 wsb"> 9</span></span></div><div class="t m0 x13 h21 y4b ff4 fsf fc1 sc0 ls0 ws1">Carácter <span class="blank _0"></span>T<span class="blank _2"></span>écnico y Cientí\ue61ec<span class="blank _0"></span>o del INVIMA<span class="ls2 wsa">.............................................<span class="blank"> </span></span><span class="wsd"> 9</span></div><div class="t m0 x13 h21 y4c ff4 fsf fc1 sc0 ls0 ws1">Competencias del INVIM<span class="blank _0"></span>A<span class="ls2 wse"> ..........................................................<span class="blank _3"> </span></span><span class="wsd"> 9</span></div><div class="t m0 x13 h21 y4d ff4 fsf fc1 sc0 ls0 ws1">El INVIMA en el P<span class="blank _0"></span>aís<span class="ls2 wsa">.................................................................<span class="blank"> </span></span><span class="wsf"> 10</span></div><div class="t m0 xb h20 y4e ff1 fsf fc1 sc0 ls1 ws10">ABC DE DISPOSITIV<span class="blank _0"></span>OS MÉDIC<span class="blank _0"></span>OS<span class="blank _4"> </span><span class="ff4 ls2 wsa">....................................................<span class="blank"> </span><span class="ls0 ws11"> 13</span></span></div><div class="t m0 x13 h21 y4f ff4 fsf fc1 sc0 ls0 ws1">I. DEFINICIONES<span class="ls2 ws12"> ....................................................................<span class="blank _3"> </span></span><span class="wsf"> 13</span></div><div class="t m0 x14 h21 y50 ff4 fsf fc1 sc0 ls0 ws1">¿Qué son los dispositivos médicos?<span class="ls2 wsa">..............................................<span class="blank"> </span></span><span class="wsf"> 13</span></div><div class="t m0 x13 h21 y51 ff4 fsf fc1 sc0 ls0 ws1">II. CLASIFICACIÓN DE RIESGO DE L<span class="blank _0"></span>OS DISPOSITIVOS MÉDIC<span class="blank _0"></span>OS<span class="ls2 ws13"> .......................<span class="blank _3"> </span></span><span class="wsf"> 21</span></div><div class="t m0 x14 h21 y52 ff4 fsf fc1 sc0 ls0 ws1">Clasi\ue61ecación de los dispositivos médicos<span class="ls2 ws14"> ........................................<span class="blank _3"> </span></span><span class="wsf"> 21</span></div><div class="t m0 x14 h21 y53 ff4 fsf fc1 sc0 ls0 ws1">F<span class="blank _2"></span>A<span class="blank _0"></span>C<span class="blank _1"> </span>TORES QUE INFL<span class="blank _0"></span>UYEN EN LA CLASIFICA<span class="blank _0"></span>CIÓN<span class="ls2 ws15"> ................................<span class="blank _3"> </span></span><span class="wsf"> 22</span></div><div class="t m0 x13 h21 y54 ff4 fsf fc1 sc0 ls0 ws1">III. REGISTROS SANIT<span class="blank _2"></span>ARIOS<span class="blank _5"> </span><span class="ls2 wsa">..........................................................<span class="blank"> </span></span><span class="wsf"> 30</span></div><div class="t m0 x14 h21 y55 ff4 fsf fc1 sc0 ls0 ws1">Registro Sanitario Contr<span class="blank _0"></span>ol Previo:<span class="blank _1"> </span><span class="ls2 wsa">................................................<span class="blank"> </span></span><span class="wsf"> 30</span></div><div class="t m0 x14 h21 y56 ff4 fsf fc1 sc0 ls0 ws1">Registro Sanitario Aut<span class="blank _0"></span>omático:<span class="ls2 ws16"> ..................................................<span class="blank _3"> </span></span><span class="wsf"> 31</span></div><div class="t m0 x14 h21 y57 ff4 fsf fc1 sc0 ls0 ws1">Requisitos para la Evaluación <span class="blank _2"></span>T<span class="blank _2"></span>écnica de los Dispositivos Médicos y Equipos </div><div class="t m0 x14 h21 y58 ff4 fsf fc1 sc0 ls0 ws1">Biomédicos que no sean de tecnología c<span class="blank _0"></span>ontrolada:<span class="ls2 ws17"> ..............................<span class="blank _3"> </span></span><span class="wsf"> 31</span></div><div class="t m0 x14 h21 y59 ff4 fsf fc1 sc0 ls0 ws1">De los equipos biomédicos de tecnología con<span class="blank _0"></span>trolada. Ar<span class="blank _1"> </span>tículo 24 </div><div class="t m0 x14 h21 y5a ff4 fsf fc1 sc0 ls0 ws1">Decreto 4725 de 2005. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <span class="blank _5"> </span><span class="wsf"> 37</span></div><div class="t m0 x13 h21 y5b ff4 fsf fc1 sc0 ls0 ws1">IV<span class="blank _2"></span>. REQUERIMIENTOS GENERALES P<span class="blank _2"></span>ARA L<span class="blank _0"></span>OS EQUIPOS BIOMÉDIC<span class="blank _0"></span>OS </div><div class="t m0 x15 h21 y5c ff4 fsf fc1 sc0 ls0 ws18">DE TECNOL<span class="blank _0"></span>OGÍA <span class="blank _1"> </span>CONTROLADA. <span class="blank _3"> </span><span class="ls2 wsa">.................................................<span class="blank"> </span></span><span class="wsf"> 43</span></div><div class="t m0 x13 h21 y5d ff4 fsf fc1 sc0 ls0 ws1">V<span class="blank _2"></span>. IMPOR<span class="blank _1"> </span>T<span class="blank _2"></span>ACIÓN <span class="blank _2"></span>TEMPORAL<span class="ls2 ws19"> .......................................................<span class="blank _3"> </span></span><span class="wsf"> 44</span></div><div class="t m0 x13 h21 y5e ff4 fsf fc1 sc0 ls0 ws1">VI. EMP<span class="blank _2"></span>A<span class="blank _0"></span>QUE, E<span class="blank _1"> </span>TIQUET<span class="blank _2"></span>ADO <span class="blank _0"></span>Y PUBLICIDAD<span class="ls2 ws1a"> ..........................................<span class="blank _5"> </span></span><span class="wsf"> 44</span></div><div class="t m0 x13 h21 y5f ff4 fsf fc1 sc0 ls0 ws1">VII. <span class="blank _0"></span>TERMINOS LEGALES P<span class="blank _2"></span>ARA L<span class="blank _0"></span>OS <span class="blank _0"></span>TRÁMITES DE REGISTROS SANIT<span class="blank _2"></span>ARIOS </div><div class="t m0 x16 h21 y60 ff4 fsf fc1 sc0 ls0 ws18">Y TRÁMITES <span class="blank _1"> </span>ASOCIADOS <span class="blank _5"> </span><span class="ls2 ws1b"> ........................................................<span class="blank _3"> </span></span><span class="wsf"> 48</span></div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf4" class="pf w0 h0" data-page-no="4"><div class="pc pc4 w0 h0"></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf5" class="pf w0 h0" data-page-no="5"><div class="pc pc5 w0 h0"><img fetchpriority="low" loading="lazy" class="bi xb y61 w3 h22" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg5.png"><div class="t m0 xc h12 y3a ff5 fsf fc1 sc0 ls0 ws1">ABC <span class="fs10 ws5">dispositivos</span> <span class="fs10 ws5">médiCos</span></div><div class="t m0 xd h13 y3b ff1 fs11 fc1 sc0 ls0">7</div><div class="t me xe h14 y3c ff6 fs12 fc1 sc0 ls0">L</div><div class="t mf xe h15 y3d ff6 fs13 fc1 sc0 ls0">i</div><div class="t m10 xe h16 y3e ff6 fs14 fc1 sc0 ls0">b</div><div class="t m11 xe h17 y3f ff6 fs15 fc1 sc0 ls0">e</div><div class="t m12 xf h18 y40 ff6 fs16 fc1 sc0 ls0">r</div><div class="t m13 xf h19 y41 ff6 fs17 fc1 sc0 ls0">t</div><div class="t m14 xf h1a y42 ff6 fs18 fc1 sc0 ls0">a</div><div class="t m15 x10 h1b y43 ff6 fs19 fc1 sc0 ls0">y</div><div class="t m16 x10 h18 y40 ff6 fs16 fc1 sc0 ls0">O</div><div class="t m17 x11 h1c y44 ff6 fs1a fc1 sc0 ls0">r</div><div class="t m18 x11 h1d y45 ff6 fs1b fc1 sc0 ls0">d</div><div class="t m19 x11 h1e y46 ff6 fs1c fc1 sc0 ls0">e</div><div class="t m1a x11 h18 y47 ff6 fs16 fc1 sc0 ls0">n</div><div class="t m0 x1 h1f y62 ff7 fs1d fc0 sc0 ls4 ws1c">Intro<span class="blank"> </span>du<span class="blank"> </span>c<span class="blank"> </span>c<span class="blank"> </span>i<span class="blank"> </span>ón</div><div class="t m0 x17 h21 y63 ff4 fsf fc1 sc0 ls0 ws1e">El INVIMA como institución líder en el Sist<span class="blank _0"></span>ema Nacional de V<span class="blank _0"></span>igilancia Sanitaria, busca proteger </div><div class="t m0 xb h20 y64 ff4 fsf fc1 sc0 ls0 ws1f">y promov<span class="blank _0"></span>er la salud de la población, mediante la gestión del riesgo<span class="ff1 ws1"> </span>asociada al consumo y uso </div><div class="t m0 xb h21 y65 ff4 fsf fc1 sc0 ls0 ws20">de los productos y tecnologías objet<span class="blank _0"></span>o de vigilancia sanitaria contemplados en el ar<span class="blank _1"> </span>tículo 245 </div><div class="t m0 xb h21 y66 ff4 fsf fc1 sc0 ls0 ws1">de Ley 100 de 1993, y artículo 2° del Decreto 2078 de 2012. </div><div class="t m0 x17 h21 y67 ff4 fsf fc1 sc0 ls0 ws21">Nuestra Institución como Autoridad Sanitaria del orden nacional y encar<span class="blank _0"></span>gada de la ejecución </div><div class="t m0 xb h21 y68 ff4 fsf fc1 sc0 ls0 ws22">de las políticas en materia de vigilancia sanitaria y de contr<span class="blank _0"></span>ol de calidad, entre otr<span class="blank _0"></span>os productos, </div><div class="t m0 xb h21 y69 ff4 fsf fc1 sc0 ls0 ws23">de los Dispositivos Médicos<span class="blank _0"></span>, al establecer mecanismos efectivos que permitan optimizar </div><div class="t m0 xb h21 y6a ff4 fsf fc1 sc0 ls0 ws24">la interrelación c<span class="blank _0"></span>on los usuarios cuyas ac<span class="blank _1"> </span>tividades están relacionadas c<span class="blank _0"></span>on la producción, </div><div class="t m0 xb h21 y6b ff4 fsf fc1 sc0 ls0 ws25">impor<span class="blank _1"> </span>tación, exportación, almacenamiento<span class="blank _0"></span>, comercialización, uso y mantenimiento de est<span class="blank _0"></span>os </div><div class="t m0 xb h21 y6c ff4 fsf fc1 sc0 ls0 ws1">productos, mejora la c<span class="blank _0"></span>on\ue61eanza y la legitimidad de la gestión institucional.</div><div class="t m0 x17 h20 y6d ff4 fsf fc1 sc0 ls0 ws1a">En este cont<span class="blank _0"></span>ex<span class="blank _1"> </span>to<span class="blank _0"></span>, me es grato<span class="blank _0"></span>, presentar a la c<span class="blank _0"></span>omunidad en general el <span class="ff1 ws26">ABC DE DISPOSITIVOS </span></div><div class="t m0 xb h20 y6e ff1 fsf fc1 sc0 ls0 ws1d">MÉDIC<span class="blank _0"></span>OS<span class="ff4 ws27">, fruto de la labor conjunta y coor<span class="blank _0"></span>dinada entre la Asociación Nacional de Industriales </span></div><div class="t m0 xb h21 y6f ff4 fsf fc1 sc0 ls0 ws28">\u2013 ANDI, la Dirección de Dispositiv<span class="blank _0"></span>os Médicos y O<span class="blank _1"> </span>tras <span class="blank _0"></span>T<span class="blank _2"></span>ecnologías del INVIMA, y la an<span class="blank _0"></span>terior </div><div class="t m0 xb h21 y70 ff4 fsf fc1 sc0 ls0 ws29">Subdirección de Registr<span class="blank _0"></span>os Sanitarios, el cual tiene como propósito ser una guía orientadora, c<span class="blank _0"></span>on </div><div class="t m0 xb h21 y71 ff4 fsf fc1 sc0 ls0 ws2a">criterios uni\ue61ecados para la mejor aplicación de las disposiciones cont<span class="blank _0"></span>enidas en el Decreto 4725 </div><div class="t m0 xb h21 y72 ff4 fsf fc1 sc0 ls0 ws2b">de 2005 <span class="ff8 ws2c">\u201cPor el cu<span class="blank _0"></span>al se reglamenta el régimen de registros sanitarios, permiso de c<span class="blank _0"></span>omercialización y </span></div><div class="t m0 xb h21 y73 ff8 fsf fc1 sc0 ls0 ws2d">vigilancia sanitaria de los Dispositivos Médicos par<span class="blank _0"></span>a uso humano<span class="blank _0"></span>\u201d<span class="ff4 ws2e"> que facilite a los establecimientos </span></div><div class="t m0 xb h21 y74 ff4 fsf fc1 sc0 ls0 ws2f">dedicados a cualquiera de las actividades inmersas en este tipo de tecnologías<span class="blank _0"></span>, adelantar ante </div><div class="t m0 xb h21 y75 ff4 fsf fc1 sc0 ls0 ws30">el Instituto los trámites que dicha normatividad cont<span class="blank _0"></span>empla, respetando el alcance de cada una </div><div class="t m0 xb h21 y76 ff4 fsf fc1 sc0 ls0 ws1">de sus disposiciones y optimizando su gestión.</div><div class="t m0 x18 h23 y77 ff4 fs1e fc1 sc0 ls0 ws1"> </div><div class="t m0 x19 h21 y78 ff4 fsf fc1 sc0 ls0 ws1">Blanca Elvira Cajigas de A<span class="blank _0"></span>costa </div><div class="t m0 x1a h20 y79 ff1 fsf fc1 sc0 ls0 ws1">Directora General</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf6" class="pf w0 h0" data-page-no="6"><div class="pc pc6 w0 h0"></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf7" class="pf w0 h0" data-page-no="7"><div class="pc pc7 w0 h0"><img fetchpriority="low" loading="lazy" class="bi xb y61 w3 h22" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg7.png"><div class="t m0 xc h12 y3a ff5 fsf fc1 sc0 ls0 ws1">ABC <span class="fs10 ws5">dispositivos</span> <span class="fs10 ws5">médiCos</span></div><div class="t m0 xd h13 y3b ff1 fs11 fc1 sc0 ls0">9</div><div class="t me xe h14 y3c ff6 fs12 fc1 sc0 ls0">L</div><div class="t mf xe h15 y3d ff6 fs13 fc1 sc0 ls0">i</div><div class="t m10 xe h16 y3e ff6 fs14 fc1 sc0 ls0">b</div><div class="t m11 xe h17 y3f ff6 fs15 fc1 sc0 ls0">e</div><div class="t m12 xf h18 y40 ff6 fs16 fc1 sc0 ls0">r</div><div class="t m13 xf h19 y41 ff6 fs17 fc1 sc0 ls0">t</div><div class="t m14 xf h1a y42 ff6 fs18 fc1 sc0 ls0">a</div><div class="t m15 x10 h1b y43 ff6 fs19 fc1 sc0 ls0">y</div><div class="t m16 x10 h18 y40 ff6 fs16 fc1 sc0 ls0">O</div><div class="t m17 x11 h1c y44 ff6 fs1a fc1 sc0 ls0">r</div><div class="t m18 x11 h1d y45 ff6 fs1b fc1 sc0 ls0">d</div><div class="t m19 x11 h1e y46 ff6 fs1c fc1 sc0 ls0">e</div><div class="t m1a x11 h18 y47 ff6 fs16 fc1 sc0 ls0">n</div><div class="t m0 x17 h20 y63 ff4 fsf fc1 sc0 ls0 ws33">El Instituto Nacional de <span class="blank _0"></span>Vigilancia de Medicamentos y A<span class="blank _0"></span>limentos -<span class="ff1 ws1d">INVIMA</span> es un </div><div class="t m0 xb h21 y7a ff4 fsf fc1 sc0 ls0 ws34">establecimiento público del or<span class="blank _0"></span>den nacional, adscrito al Ministerio de Salud y Pr<span class="blank _0"></span>otección Social, </div><div class="t m0 xb h21 y7b ff4 fsf fc1 sc0 ls0 ws35">que como agencia sanitaria de los colombianos ejecuta las políticas en materia de vigilancia </div><div class="t m0 xb h21 y7c ff4 fsf fc1 sc0 ls0 ws1">sanitaria y control de calidad<span class="blank _0"></span>.</div><div class="t m0 x17 h21 y7d ff4 fsf fc1 sc0 ls0 ws36">El ámbito de su gestión inv<span class="blank _0"></span>olucra productos de vital impor<span class="blank _1"> </span>tancia para la sociedad como: </div><div class="t m0 xb h21 y7e ff4 fsf fc1 sc0 ls0 ws37">medicamentos<span class="blank _0"></span>, productos biológicos, pr<span class="blank _0"></span>oduc<span class="blank _1"> </span>tos naturales y homeopátic<span class="blank _0"></span>os, reactivos de </div><div class="t m0 xb h21 y7f ff4 fsf fc1 sc0 ls0 ws38">diagnóstico in vitr<span class="blank _0"></span>o, dispositivos médic<span class="blank _0"></span>os, alimentos proc<span class="blank _0"></span>esados, carnes, bebidas envasadas<span class="blank _0"></span>, </div><div class="t m0 xb h21 y80 ff4 fsf fc1 sc0 ls0 ws1">bebidas alcohólicas, c<span class="blank _0"></span>osméticos, preservativos, pr<span class="blank _0"></span>oduc<span class="blank _1"> </span>tos de aseo<span class="blank _0"></span>, entre otros<span class="blank _0"></span>.</div><div class="t m0 x17 h21 y81 ff4 fsf fc1 sc0 ls0 ws39">En concor<span class="blank _0"></span>dancia, el INVIMA ha de\ue61enido el nor<span class="blank _1"> </span>te de su gestión sobre tr<span class="blank _0"></span>es ejes fundamentales: </div><div class="t m0 xb h20 y82 ff4 fsf fc1 sc0 ls0 ws3a">garantizar la <span class="ff1">salud pública</span> en Colombia, c<span class="blank _0"></span>ontribuir a elevar el <span class="ff1">estatus sanitario</span> del país y ser </div><div class="t m0 xb h20 y83 ff4 fsf fc1 sc0 ls0 ws1">sopor<span class="blank _1"> </span>te en materia de <span class="ff1 ws1d">c<span class="blank _0"></span>ompetitividad<span class="ff4">.</span></span></div><div class="t m0 xb h13 y84 ff1 fs11 fc0 sc0 ls0 ws1">Car<span class="blank _0"></span>ác<span class="blank _1"> </span>ter <span class="blank _0"></span>T<span class="blank _6"></span>écnico y Cien<span class="blank _0"></span>tí\ue61fco del INVIMA</div><div class="t m0 x17 h21 y85 ff4 fsf fc1 sc0 ls0 ws19">En la ejecución de las políticas sanitarias, el INVIMA in<span class="blank _0"></span>teractúa con cuatro sistemas nacionales: </div><div class="t m0 xb h21 y86 ff4 fsf fc1 sc0 ls0 ws3b">Sistema de Salud Pública, Sist<span class="blank _0"></span>ema de Salud Ambiental, Sistema de Medidas Sanitarias y </div><div class="t m0 xb h21 y87 ff4 fsf fc1 sc0 ls0 ws1">F<span class="blank _0"></span>itosanitarias y Sistema de Ciencia y <span class="blank _0"></span>T<span class="blank _2"></span>ecnología. </div><div class="t m0 x17 h21 y88 ff4 fsf fc1 sc0 ls0 ws3c">El carácter técnico y cientí\ue61eco del INVIM<span class="blank _0"></span>A se sopor<span class="blank _1"> </span>ta en la interacción del Instituto con </div><div class="t m0 xb h21 y89 ff4 fsf fc1 sc0 ls0 ws3d">agencias sanitarias internacionales, or<span class="blank _0"></span>ganizaciones de la comunidad académica, agremiaciones </div><div class="t m0 xb h21 y8a ff4 fsf fc1 sc0 ls0 ws3e">cientí\ue61ecas y asociaciones de prof<span class="blank _0"></span>esionales; y al interior se fundamenta en la conformación y </div><div class="t m0 xb h21 y8b ff4 fsf fc1 sc0 ls0 ws3f">pleno funcionamiento de las seis Salas Especializadas de la C<span class="blank _0"></span>omisión Revisora (<span class="ff8 ws1">Medicamentos </span></div><div class="t m0 xb h24 y8c ff8 fsf fc1 sc0 ls0 ws40">y Productos Biológicos<span class="blank _0"></span>, Productos Naturales<span class="blank _0"></span>, Medicamentos Homeopáticos<span class="blank _0"></span>, Alimentos y Bebidas , </div><div class="t m0 xb h21 y8d ff8 fsf fc1 sc0 ls0 ws41">Dispositivos Médicos y Pr<span class="blank _0"></span>oduc<span class="blank _1"> </span>tos V<span class="blank _0"></span>arios, y Reactivos de Diagnóstic<span class="blank _0"></span>o In Vitro<span class="ff4">), en la especialización </span></div><div class="t m0 xb h21 y8e ff4 fsf fc1 sc0 ls0 ws42">de las <span class="ff9">D</span>irecciones Misionales y en la capacidad prof<span class="blank _0"></span>esional de quienes integran los equipos </div><div class="t m0 xb h21 y8f ff4 fsf fc1 sc0 ls0 ws1">de trabajo<span class="blank _0"></span>. </div><div class="t m0 xb h13 y90 ff1 fs11 fc0 sc0 ls0 ws1">C<span class="blank _0"></span>ompetencias del INVIMA</div><div class="t m0 xb h23 y91 ff4 fs1e fc1 sc0 ls0 ws43">El INVIMA desarrolla su gestión como A<span class="blank _0"></span>utoridad Sanitaria con el ejercicio de estas competencias </div><div class="t m0 xb h23 y92 ff4 fs1e fc1 sc0 ls0 ws31">fundamentales:</div><div class="t m0 x1b h1f y62 ff7 fs1d fc0 sc0 ls0 ws32">P<span class="blank _0"></span>resen<span class="blank _0"></span>taci<span class="blank _1"> </span>ón</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf8" class="pf w0 h0" data-page-no="8"><div class="pc pc8 w0 h0"><img fetchpriority="low" loading="lazy" class="bi x1c y93 w4 h25" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg8.png"><div class="t m0 x1d h12 y3a ffa fsf fc1 sc0 ls0 ws1">ABC <span class="fs10 ws5">dispositivos</span> <span class="fs10 ws5">médiCos</span></div><div class="t m0 x1e h13 y3b ff1 fs11 fc1 sc0 ls0">10</div><div class="t me x1f h14 y3c ffb fs12 fc1 sc0 ls0">L</div><div class="t mf x1f h15 y3d ffb fs13 fc1 sc0 ls0">i</div><div class="t m10 x1f h16 y3e ffb fs14 fc1 sc0 ls0">b</div><div class="t m11 x1f h17 y3f ffb fs15 fc1 sc0 ls0">e</div><div class="t m12 x20 h18 y40 ffb fs16 fc1 sc0 ls0">r</div><div class="t m13 x20 h19 y41 ffb fs17 fc1 sc0 ls0">t</div><div class="t m14 x20 h1a y42 ffb fs18 fc1 sc0 ls0">a</div><div class="t m15 x21 h1b y43 ffb fs19 fc1 sc0 ls0">y</div><div class="t m16 x21 h18 y40 ffb fs16 fc1 sc0 ls0">O</div><div class="t m17 x22 h1c y44 ffb fs1a fc1 sc0 ls0">r</div><div class="t m18 x22 h1d y45 ffb fs1b fc1 sc0 ls0">d</div><div class="t m19 x22 h1e y46 ffb fs1c fc1 sc0 ls0">e</div><div class="t m1a x22 h18 y47 ffb fs16 fc1 sc0 ls0">n</div><div class="t m0 x23 h21 y94 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Expedición de Registros Sanitarios, P<span class="blank _0"></span>ermisos Sanitarios y Noti\ue61ecaciones Sanitarias</div><div class="t m0 x23 h21 y95 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Visitas de C<span class="blank _0"></span>er<span class="blank _1"> </span>ti\ue61ecación</div><div class="t m0 x23 h21 y96 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Acciones de Inspección <span class="blank _0"></span>V<span class="blank _0"></span>igilancia y Control</div><div class="t m0 x23 h21 y97 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Vig<span class="blank _0"></span>ilancia pre y post comercialización, y prog<span class="blank _0"></span>ramas especiales</div><div class="t m0 x23 h21 y98 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Laboratorio Nacional de Refer<span class="blank _0"></span>encia</div><div class="t m0 x23 h21 y99 ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Armonización Normativa en materia sanitaria</div><div class="t m0 x23 h21 y9a ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Gestión del Conocimiento e Inv<span class="blank _0"></span>estigación Aplicada</div><div class="t m0 x23 h21 y9b ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Capacitación y Asistencia <span class="blank _2"></span>T<span class="blank _2"></span>écnica</div><div class="t m0 x23 h21 y9c ff4 fsf fc1 sc0 ls0 ws1"> <span class="blank _7"></span>»<span class="blank _8"> </span>Pr<span class="blank _0"></span>ocesos sancionatorios</div><div class="t m0 xb h13 y9d ff1 fs11 fc0 sc0 ls0 ws1">El INVIMA en el País</div><div class="t m0 x17 h21 y9e ff4 fsf fc1 sc0 ls0 ws44">Con el objetiv<span class="blank _0"></span>o de consolidar la presencia del Instituto en el País<span class="blank _0"></span>, el INVIMA ha puesto al </div><div class="t m0 xb h20 y9f ff4 fsf fc1 sc0 ls0 ws45">ser<span class="blank _1"> </span>vicio de los colombianos nueve <span class="ff1 ws46">Grupos <span class="blank _1"> </span>de T<span class="blank _2"></span>rabajo T<span class="blank _2"></span>erritorial<span class="ff4 ws45"> con la capacidad técnica, </span></span></div><div class="t m0 xb h21 ya0 ff4 fsf fc1 sc0 ls0 ws1">cientí\ue61eca y administrativa par<span class="blank _0"></span>a asumir todas\ue61fsus competencias.</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pf9" class="pf w0 h0" data-page-no="9"><div class="pc pc9 w0 h0"><img fetchpriority="low" loading="lazy" class="bi x24 ya1 w5 h26" alt="" src="https://files.passeidireto.com/e2a238de-d3a5-495c-9227-4e90f7fb6fe6/bg9.png"><div class="t m0 xc h12 y3a ff5 fsf fc1 sc0 ls0 ws1">ABC <span class="fs10 ws5">dispositivos</span> <span class="fs10 ws5">médiCos</span></div><div class="t m0 x25 h13 y3b ff1 fs11 fc1 sc0 ls0">11</div><div class="t me xe h14 y3c ff6 fs12 fc1 sc0 ls0">L</div><div class="t mf xe h15 y3d ff6 fs13 fc1 sc0 ls0">i</div><div class="t m10 xe h16 y3e ff6 fs14 fc1 sc0 ls0">b</div><div class="t m11 xe h17 y3f ff6 fs15 fc1 sc0 ls0">e</div><div class="t m12 xf h18 y40 ff6 fs16 fc1 sc0 ls0">r</div><div class="t m13 xf h19 y41 ff6 fs17 fc1 sc0 ls0">t</div><div class="t m14 xf h1a y42 ff6 fs18 fc1 sc0 ls0">a</div><div class="t m15 x10 h1b y43 ff6 fs19 fc1 sc0 ls0">y</div><div class="t m16 x10 h18 y40 ff6 fs16 fc1 sc0 ls0">O</div><div class="t m17 x11 h1c y44 ff6 fs1a fc1 sc0 ls0">r</div><div class="t m18 x11 h1d y45 ff6 fs1b fc1 sc0 ls0">d</div><div class="t m19 x11 h1e y46 ff6 fs1c fc1 sc0 ls0">e</div><div class="t m1a x11 h18 y47 ff6 fs16 fc1 sc0 ls0">n</div><div class="t m0 x17 h21 y94 ff4 fsf fc1 sc0 ls0 ws1">Los Grupos de <span class="blank _2"></span>T<span class="blank _0"></span>rabajo <span class="blank _0"></span>T<span class="blank _2"></span>erritorial del INVIMA y sus ciudades sedes, son: </div><div class="t m0 xb h20 y95 ff1 fsf fc1 sc0 ls0 ws1">1. <span class="blank _9"> </span><span class="ws49">Costa C<span class="blank _0"></span>aribe 1 con sede en Barranquilla<span class="ff4 ws4a"> y cobertura en Atlántico<span class="blank _0"></span>, Guajira, Magdalena y </span></span></div><div class="t m0 x26 h21 ya2 ff4 fsf fc1 sc0 ls0 ws1">Cesar </div><div class="t m0 xb h20 ya3 ff1 fsf fc1 sc0 ls0 ws1">2. <span class="blank _9"> </span>Costa C<span class="blank _0"></span>aribe 2 con sede en Montería<span class="ff4"> y cobertura en Córdoba, Sucr<span class="blank _0"></span>e, Bolívar y Bogotá</span></div><div class="t m0 xb h20 ya4 ff1 fsf fc1 sc0 ls0 ws1">3. <span class="blank _9"> </span><span class="ws43">Cen<span class="blank _0"></span>tro Oriente 1 con sede en Bucaramanga<span class="ff4 ws4b"> y c<span class="blank _0"></span>ober<span class="blank _1"> </span>tura en Santander y Nor<span class="blank _1"> </span>te de </span></span></div><div class="t m0 x26 h21 ya5 ff4 fsf fc1 sc0 ls0 ws47">Santander</div><div class="t m0 xb h20 ya6 ff1 fsf fc1 sc0 ls0 ws1">4. <span class="blank _9"> </span><span class="ws4c">Cen<span class="blank _0"></span>tro Oriente 2 con sede en Bogotá<span class="ff4 ws1b"> y cobertura en Boyacá, Cundinamarca y A<span class="blank _0"></span>mazonas </span></span></div><div class="t m0 x26 h21 ya7 ff4 fsf fc1 sc0 ls0 ws1">y San Andrés</div><div class="t m0 xb h20 ya8 ff1 fsf fc1 sc0 ls0 ws1">5. <span class="blank _9"> </span>Cen<span class="blank _0"></span>tro Oriente 3 con sede en Neiv<span class="blank _0"></span>a<span class="ff4"> y cober<span class="blank _1"> </span>tura en <span class="blank _0"></span>T<span class="blank _2"></span>olima, Huila y Caquetá</span></div><div class="t m0 xb h20 ya9 ff1 fsf fc1 sc0 ls0 ws1">6. <span class="blank _9"> </span><span class="ws4d">Occident<span class="blank _0"></span>e 1 con sede en Medellín <span class="ff4 ws25">y cober<span class="blank _1"> </span>tura en Antioquia, Chocó<span class="blank _0"></span>, Caldas, Quindío y </span></span></div><div class="t m0 x26 h21 yaa ff4 fsf fc1 sc0 ls0 ws1">Risaralda </div><div class="t m0 xb h20 yab ff1 fsf fc1 sc0 ls0 ws1">7. <span class="blank _9"> </span>Occident<span class="blank _0"></span>e 2 con sede en Cali<span class="ff4"> y cobertura en <span class="blank _0"></span>V<span class="blank _0"></span>alle del Cauca, Cauca, Nariño y Putumay<span class="blank _0"></span>o </span></div><div class="t m0 xb h20 yac ff1 fsf fc1 sc0 ls0 ws1">8. <span class="blank _9"> </span><span class="ws4e">Orinoquía con sede en <span class="blank _0"></span>V<span class="blank _0"></span>illavicencio<span class="ff4 ws4f"> y cobertura en Meta, Casanare<span class="blank _0"></span>, Arauca, Guaviare<span class="blank _0"></span>, </span></span></div><div class="t m0 x26 h21 yad ff4 fsf fc1 sc0 ls0 ws50">Guainía, Vichada y Vaupés</div><div class="t m0 xb h20 yae ff1 fsf fc1 sc0 ls0 ws1">9. <span class="blank _9"> </span>Eje Caf<span class="blank _0"></span>etero con sede en Armenia <span class="ff4">y c<span class="blank _0"></span>ober<span class="blank _1"> </span>tura en Caldas, Risaralda y Quindío<span class="blank _0"></span>.</span></div><div class="t m0 x17 h24 yaf ff8 fsf fc1 sc0 ls0 ws51">El INVIMA desarrolla su gestión, siempre en procur<span class="blank _0"></span>a de la salud y el bienestar de todos los </div><div class="t m0 xb h24 yb0 ff8 fsf fc1 sc0 ls0 ws48">colombianos.</div></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div> <div id="pfa" class="pf w0 h0" data-page-no="a"><div class="pc pca w0 h0"></div><div class="pi" data-data="{"ctm":[1.000000,0.000000,0.000000,1.000000,0.000000,0.000000]}"></div></div>
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