{"id":5257,"date":"2025-02-20T09:09:33","date_gmt":"2025-02-20T09:09:33","guid":{"rendered":"https:\/\/kelingmed.com\/?p=5257"},"modified":"2025-02-20T09:10:30","modified_gmt":"2025-02-20T09:10:30","slug":"drc-wheelchair-regulatory-compliance-guide","status":"publish","type":"post","link":"https:\/\/kelingmed.com\/sl\/drc-wheelchair-regulatory-compliance-guide\/","title":{"rendered":"DRC Skladnost medicinskih pripomo\u010dkov 2025: Invalidski vozi\u010dek Certificiranje in regulativne strategije"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5257\" class=\"elementor elementor-5257\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a5049cf e-flex e-con-boxed e-con e-parent\" data-id=\"2a5049cf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1deaec80 elementor-widget elementor-widget-theme-post-featured-image\" data-id=\"1deaec80\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b9024a9 elementor-widget elementor-widget-post-info\" data-id=\"b9024a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9384c2c elementor-widget elementor-widget-theme-post-title\" data-id=\"9384c2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-315d4386 elementor-widget elementor-widget-post-info\" data-id=\"315d4386\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3bcd2f1f elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"3bcd2f1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dcd7766 elementor-widget elementor-widget-text-editor\" data-id=\"dcd7766\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"md-end-block md-p md-focus\">\u00a0<\/p><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">1. Sistem razvr\u0161\u010danja medicinskih pripomo\u010dkov DRC<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">\u0160tiristopenjska razvrstitev<\/span><\/strong><\/span> <span class=\"md-plain\">Ministrstvo za zdravje DR Kongo invalidske vozi\u010dke in pripomo\u010dke za gibanje razvr\u0161\u010da v razli\u010dne kategorije tveganja.<\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Ministrstvo za zdravje Demokrati\u010dne republike Kongo navaja ro\u010dne invalidske vozi\u010dke brez prilagoditev po meri kot pripomo\u010dke razreda I, ki predstavljajo 75% uvoza.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Sistem razvr\u0161\u010danja DRC uvr\u0161\u010da elektri\u010dne invalidske vozi\u010dke z osnovnim programirljivim upravljanjem v razred IIa (srednje tveganje).<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">\u0160portni in prilagodljivi invalidski vozi\u010dki s prefinjenimi ergonomskimi funkcijami spadajo v razred IIb (ve\u010dje tveganje).<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Motorizirani rehabilitacijski stoli z umetno inteligenco za izbolj\u0161anje mobilnosti predstavljajo kategorijo z visokim tveganjem in ti pripomo\u010dki so v DRK redko na voljo.<\/span><\/p><\/li><\/ul><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Globalna uskladitev<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Pripomo\u010dki razreda I se lahko izognejo celotnemu klini\u010dnemu presku\u0161anju, \u010de pridobijo certifikat FDA in EU MDR.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Za pripomo\u010dke razreda IIb morajo proizvajalci zagotoviti tehni\u010dno dokumentacijo v skladu s Prilogo II k Uredbi EU 2017\/745.<\/span><\/p><\/li><\/ul><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">2. Postopek certificiranja: razdelitev po korakih<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Faza 1: Pred predlo\u017eitvijo<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Priprava dokumentov<\/span><\/strong><\/span><span class=\"md-plain\">: <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Tehni\u010dna dokumentacija vklju\u010duje projektne specifikacije, skladne s standardom ISO 13485, in dokumente o analizi tveganja.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">ozna\u010devanje v francoskem jeziku (obvezno za navodila za uporabo) <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Imenujte zastopnika v Kin\u0161asi, ki bo skrbel za povezave z ministrstvom in bo pla\u010dal standardno letno pristojbino med $2,000 in $5,000. pristojbina: $2,000-$5,000\/leto). <\/span><\/p><\/li><\/ul><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Faza 2: Pregled Ministrstva za zdravje<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">\u010casovni na\u010drti<\/span><\/strong><\/span><span class=\"md-plain\">: <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred I: 90-120 dni <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred IIa: 150-180 dni <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred IIb: 210-240 dni <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Pristojbine<\/span><\/strong><\/span><span class=\"md-plain\">: <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred I: $1,200 <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred IIa: $3,800 <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Razred IIb: $6,500 <\/span><\/p><\/li><\/ul><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Faza 3: Nadzor po dajanju na trg<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Za vse razrede je potrebno letno varnostno poro\u010dilo. <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">uveljavljanje 24-mese\u010dne garancije za elektri\u010dne invalidske vozi\u010dke. <\/span><\/p><\/li><\/ul><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">3. Izjeme in vrzeli pri klini\u010dnem testiranju<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Upravi\u010denost do izvzetja<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Naprave, ki spadajo v razred I, so v celoti izvzete, \u010de pridobijo certifikat na podlagi standardov FDA 510(k) ali EU MDR.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Naprave razreda IIa<\/span><\/strong><\/span><span class=\"md-plain\">: Delna oprostitev za: <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Medicinski pripomo\u010dki, ki so na trgih OECD na voljo ve\u010d kot pet let.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Izdelki, ki ustrezajo seznamu osnovnih podpornih tehnologij Svetovne zdravstvene organizacije. <\/span><\/p><\/li><\/ul><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Strate\u0161ki obvozi<\/span><\/strong><\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Kot podporne podatke uporabite klini\u010dne ocene s podobnih trgov, kot sta Ju\u017ena Afrika ali Kenija.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Izvedite kratke preskuse uporabnosti pri 10-15 bolnikih, da nadomestite celotna klini\u010dna presku\u0161anja in dose\u017eete zmanj\u0161anje stro\u0161kov za 60%.<\/span><\/p><\/li><\/ul><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">4. \u0160tudija primera: Elektri\u010dni invalidski vozi\u010dki srednjega cenovnega razreda<\/span><\/strong><\/span><\/h2><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Distributer je imel 10-mese\u010dno zamudo pri certificiranju za razred IIa, ker ni imel popolnih poro\u010dil o preskusih IEC 60601-1.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Re\u0161itev<\/span><\/strong><\/span><span class=\"md-plain\">: <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Distributer je motorje poslal v presku\u0161evalnico, ki jo je odobrila EU, v Tunizijo, kjer je bilo opravljeno ponovno presku\u0161anje, ki je stalo $8.200.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Za pospe\u0161itev postopka pregleda je sodeloval s svetovalcem za skladnost s predpisi v Kin\u0161asi.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Postopek certificiranja se je zaklju\u010dil v 137 dneh, kar je 43% hitreje od obi\u010dajnega \u010dasovnega okvira v panogi.<\/span><\/p><\/li><\/ul><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">5. Kazni za neskladnost<\/span><\/strong><\/span><\/h2><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Kazni za manj\u0161e kr\u0161itve, kot so napake pri ozna\u010devanju, so globe do $12.000 skupaj s 30-dnevno prekinitvijo uvoza.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Ve\u010dje kr\u0161itve<\/span><\/strong><\/span><span class=\"md-plain\"> (npr. neregistrirane naprave): <\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Najvi\u0161je kazni zna\u0161ajo 5% letnih prihodkov podjetja v DRK.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">izklju\u010ditev iz \u010drnega seznama dr\u017eavnih razpisov za 3 leta. <\/span><\/p><\/li><\/ul><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">6. Strategije optimizacije stro\u0161kov<\/span><\/strong><\/span><\/h2><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Postopek mno\u017ei\u010dnega certificiranja podjetjem omogo\u010da, da predlo\u017eijo eno vlogo za registracijo 5 do 10 modelov, kar zmanj\u0161a stro\u0161ke za 20 do 35% na izdelek.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Izvedite modularne zasnove, kot so zamenljive blazine, da prepre\u010dite potrebo po ponovnem certificiranju.<\/span><\/p><\/li><\/ul><div class=\"md-hr md-end-block\" tabindex=\"-1\"><hr \/><\/div><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Zaklju\u010dek<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-plain\">Regulativni sistem Demokrati\u010dne republike Kongo zagotavlja spodbude distributerjem, ki se aktivno prilagajajo hibridnemu modelu, ki temelji na standardih FDA in EU. Poudarek na certificiranju razreda I v kombinaciji z oprostitvami klini\u010dnega testiranja in nalo\u017ebami v lokalno zastopstvo omogo\u010da dobaviteljem, da skraj\u0161ajo svoj \u010das uvajanja na trg za 40% in hkrati prepre\u010dijo drage kazni. Podjetja, ki bodo zgodaj uvedla najbolj\u0161e prakse skladnosti, bodo obvladovala $9,2 milijonski trg storitev certificiranja invalidskih vozi\u010dkov, saj bodo leta 2025 ukrepi izvr\u0161evanja postali stro\u017eji.<\/span><\/p><div class=\"md-hr md-end-block\" tabindex=\"-1\"><hr \/><\/div><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Oddelek Pogosta vpra\u0161anja<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">V1: Postopek za pridobitev certifikata za invalidske vozi\u010dke razreda I traja od 90 do 120 dni v letu 2025, \u010de dokumentacija izpolnjuje zahteve EU MDR. <\/span><\/strong><\/span> <span class=\"md-plain\">O: Postopek certificiranja invalidskih vozi\u010dkov razreda I traja od 90 do 120 dni, \u010de dokumentacija izpolnjuje standarde EU MDR.<\/span><\/p><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">V2: Ali je dovoljeno uporabiti podatke FDA 510(k) za namene predlo\u017eitve DRC? <\/span><\/strong><\/span> <span class=\"md-plain\">O: Tehni\u010dne datoteke FDA omogo\u010dajo prenosljivost 70% za predlo\u017eitve DRC, kar skraj\u0161a \u010das priprave 50%.<\/span><\/p><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">V3: Ali so obnovljeni invalidski vozi\u010dki izvzeti iz certificiranja? <\/span><\/strong><\/span> <span class=\"md-plain\">O: Vsaka naprava mora biti v celoti registrirana v razredih I-III ne glede na njeno stanje, vklju\u010dno z obnovljenimi izdelki.<\/span><\/p><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">V4: Kak\u0161na je kazen za nepravilno francosko ozna\u010devanje? <\/span><\/strong><\/span> <span class=\"md-plain\">O: Do $12.000 globe + obvezen odpoklic izdelka. <\/span><\/p><div class=\"md-hr md-end-block\" tabindex=\"-1\"><hr \/><\/div><h2 class=\"md-end-block md-heading\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Zagotovite si brezskrbno skladnost z DRC s podjetjem Keling Medical<\/span><\/strong><\/span><\/h2><p class=\"md-end-block md-p\"><span class=\"md-plain\">Keling Medical poenostavi certificiranje invalidskih vozi\u010dkov za distributerje: <\/span><\/p><ul class=\"ul-list\" data-mark=\"-\"><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Pridobite lahko tehni\u010dne datoteke za takoj\u0161njo predlo\u017eitev z ve\u010d kot 15 predhodno certificiranih modelov invalidskih vozi\u010dkov razreda I\/IIa.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Na\u0161a ekipa v Kin\u0161asi vodi revizijske postopke in pogajanja z ministrstvom.<\/span><\/p><\/li><li class=\"md-list-item\"><p class=\"md-end-block md-p\"><span class=\"md-plain\">Pakete za mno\u017ei\u010dno certificiranje lahko distributerji zmanj\u0161ajo stro\u0161ke za \u010detrtino.<\/span><\/p><\/li><\/ul><p class=\"md-end-block md-p\"><span class=\"md-plain\">\ud83d\udce9 <\/span><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Stopite v stik z na\u0161imi strokovnjaki za regulacijo<\/span><\/strong><\/span><span class=\"md-plain\">: <\/span> <span class=\"md-plain\">\ud83d\udce7 E-po\u0161ta: <\/span><span class=\"md-link md-pair-s\" spellcheck=\"false\"><a href=\"mailto:inquiry@shkeling.com\">inquiry@shkeling.com<\/a><\/span> <span class=\"md-plain\">\ud83d\udcde WhatsApp: +<\/span><span class=\"md-meta-i-c  md-link\"><a href=\"https:\/\/web.whatsapp.com\/send?phone=8618221822482\" target=\"_blank\" rel=\"noopener\"><span class=\"md-plain\"> Whatsapp:8618221822482<\/span><\/a><\/span> <span class=\"md-plain\">\ud83c\udf10 Ve\u010d informacij: <\/span><span class=\"md-meta-i-c  md-link\"><a href=\"\/product-category\/wheelchair\/\"><span class=\"md-plain\">https:\/\/kelingmed.com\/product-category\/wheelchair\/<\/span><\/a><\/span><\/p><p class=\"md-end-block md-p\"><span class=\"md-pair-s\"><strong><span class=\"md-plain\">Ekskluzivna ponudba<\/span><\/strong><\/span><span class=\"md-plain\">: Brezpla\u010dna analiza regulativne vrzeli za prve prijavitelje! <\/span><\/p><div class=\"md-hr md-end-block\" tabindex=\"-1\">\u00a0<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e48a11a elementor-widget elementor-widget-share-buttons\" data-id=\"e48a11a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"share-buttons.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-691950e elementor-widget elementor-widget-wpforms\" data-id=\"691950e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style id=\"wpforms-css-vars-root\">\n\t\t\t\t:root {\n\t\t\t\t\t--wpforms-field-border-radius: 3px;\n--wpforms-field-background-color: #ffffff;\n--wpforms-field-border-color: rgba( 0, 0, 0, 0.25 );\n--wpforms-field-text-color: rgba( 0, 0, 0, 0.7 );\n--wpforms-label-color: rgba( 0, 0, 0, 0.85 );\n--wpforms-label-sublabel-color: rgba( 0, 0, 0, 0.55 );\n--wpforms-label-error-color: #d63637;\n--wpforms-button-border-radius: 3px;\n--wpforms-button-background-color: #066aab;\n--wpforms-button-text-color: #ffffff;\n--wpforms-field-size-input-height: 43px;\n--wpforms-field-size-input-spacing: 15px;\n--wpforms-field-size-font-size: 16px;\n--wpforms-field-size-line-height: 19px;\n--wpforms-field-size-padding-h: 14px;\n--wpforms-field-size-checkbox-size: 16px;\n--wpforms-field-size-sublabel-spacing: 5px;\n--wpforms-field-size-icon-size: 1;\n--wpforms-label-size-font-size: 16px;\n--wpforms-label-size-line-height: 19px;\n--wpforms-label-size-sublabel-font-size: 14px;\n--wpforms-label-size-sublabel-line-height: 17px;\n--wpforms-button-size-font-size: 17px;\n--wpforms-button-size-height: 41px;\n--wpforms-button-size-padding-h: 15px;\n--wpforms-button-size-margin-top: 10px;\n\n\t\t\t\t}\n\t\t\t<\/style><style id=\"wpforms-css-vars-elementor-widget-691950e\">\n\t\t\t\t.elementor-widget-wpforms.elementor-element-691950e {\n\t\t\t\t\t--wpforms-field-size-input-height: 43px;\n--wpforms-field-size-input-spacing: 15px;\n--wpforms-field-size-font-size: 16px;\n--wpforms-field-size-line-height: 19px;\n--wpforms-field-size-padding-h: 14px;\n--wpforms-field-size-checkbox-size: 16px;\n--wpforms-field-size-sublabel-spacing: 5px;\n--wpforms-field-size-icon-size: 1;\n--wpforms-label-size-font-size: 16px;\n--wpforms-label-size-line-height: 19px;\n--wpforms-label-size-sublabel-font-size: 14px;\n--wpforms-label-size-sublabel-line-height: 17px;\n--wpforms-button-size-font-size: 17px;\n--wpforms-button-size-height: 41px;\n--wpforms-button-size-padding-h: 15px;\n--wpforms-button-size-margin-top: 10px;\n\n\t\t\t\t}\n\t\t\t<\/style><div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-1843\"><form id=\"wpforms-form-1843\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"1843\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/sl\/wp-json\/wp\/v2\/posts\/5257\" data-token=\"830c056f992f5ee67c4cd3288e9f9274\" data-trp-original-action=\"\/sl\/wp-json\/wp\/v2\/posts\/5257\"><noscript class=\"wpforms-error-noscript\">\u010ce \u017eelite izpolniti ta obrazec, v brskalniku omogo\u010dite JavaScript.<\/noscript><div class=\"wpforms-hidden\" id=\"wpforms-error-noscript\">\u010ce \u017eelite izpolniti ta obrazec, v brskalniku omogo\u010dite JavaScript.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-1843-field_1-container\" class=\"wpforms-field wpforms-field-layout\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-1843-field_1\" aria-hidden=\"false\">Postavitev<\/label><div class=\"wpforms-field-layout-columns wpforms-field-layout-preset-50-50\"><div class=\"wpforms-layout-column wpforms-layout-column-50\"><div id=\"wpforms-1843-field_2-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"2\"><label class=\"wpforms-field-label\" for=\"wpforms-1843-field_2\">Ime <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-1843-field_2\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][2]\" aria-errormessage=\"wpforms-1843-field_2-error\" required><\/div><div id=\"wpforms-1843-field_5-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"5\"><label class=\"wpforms-field-label\" for=\"wpforms-1843-field_5\">Telefon\/WhatsApp <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-1843-field_5\" class=\"wpforms-field-medium wpforms-field-required\" data-rule-int-phone-field=\"true\" name=\"wpforms[fields][5]\" aria-errormessage=\"wpforms-1843-field_5-error\" required><\/div><\/div><div class=\"wpforms-layout-column wpforms-layout-column-50\"><div id=\"wpforms-1843-field_3-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"3\"><label class=\"wpforms-field-label\" for=\"wpforms-1843-field_3\">E-po\u0161ta <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-1843-field_3\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][3]\" spellcheck=\"false\" aria-errormessage=\"wpforms-1843-field_3-error\" required><\/div><div id=\"wpforms-1843-field_4-container\" class=\"wpforms-field wpforms-field-text\" data-field-id=\"4\"><label class=\"wpforms-field-label\" for=\"wpforms-1843-field_4\">Povpra\u0161evanje<\/label><input type=\"text\" id=\"wpforms-1843-field_4\" class=\"wpforms-field-medium\" name=\"wpforms[fields][4]\" aria-errormessage=\"wpforms-1843-field_4-error\" ><\/div><\/div><\/div><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-turnstile\" ><div class=\"g-recaptcha\" data-sitekey=\"0x4AAAAAAAyrnCk3ccFGBLIG\" data-action=\"FormID-1843\"><\/div><input type=\"text\" name=\"g-recaptcha-hidden\" class=\"wpforms-recaptcha-hidden\" style=\"position:absolute!important;clip:rect(0,0,0,0)!important;height:1px!important;width:1px!important;border:0!important;overflow:hidden!important;padding:0!important;margin:0!important;\" data-rule-turnstile=\"1\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"1843\"><input type=\"hidden\" name=\"wpforms[author]\" value=\"1\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-1843\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Send Inquiry\" aria-live=\"assertive\" value=\"wpforms-submit\">Po\u0161lji povpra\u0161evanje<\/button><img decoding=\"async\" src=\"https:\/\/kelingmed.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Nalaganje\"><\/div><input type=\"hidden\" name=\"trp-form-language\" value=\"sl\"\/><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5fe0ce8b elementor-widget elementor-widget-post-navigation\" data-id=\"5fe0ce8b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-navigation.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c003f6 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2c003f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b985dc elementor-widget elementor-widget-woocommerce-products\" data-id=\"4b985dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"woocommerce-products.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c82ecdb elementor-widget__width-inherit elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c82ecdb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f15aa9d elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"2f15aa9d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sorodni prispevki<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63eacc46 elementor-widget__width-inherit elementor-widget elementor-widget-posts\" data-id=\"63eacc46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"posts.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-35bc29d9 e-con-full e-flex e-con e-parent\" data-id=\"35bc29d9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4c9c8029 elementor-widget elementor-widget-heading\" data-id=\"4c9c8029\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Postanimo zanesljivi partnerji<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f77b84 elementor-widget elementor-widget-wpforms\" data-id=\"9f77b84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style id=\"wpforms-css-vars-elementor-widget-9f77b84\">\n\t\t\t\t.elementor-widget-wpforms.elementor-element-9f77b84 {\n\t\t\t\t\t--wpforms-field-border-color: #000000;\n--wpforms-field-text-color: #000000;\n--wpforms-label-color: #FFFFFF;\n--wpforms-button-text-color: #FFFFFF;\n--wpforms-field-size-input-height: 43px;\n--wpforms-field-size-input-spacing: 15px;\n--wpforms-field-size-font-size: 16px;\n--wpforms-field-size-line-height: 19px;\n--wpforms-field-size-padding-h: 14px;\n--wpforms-field-size-checkbox-size: 16px;\n--wpforms-field-size-sublabel-spacing: 5px;\n--wpforms-field-size-icon-size: 1;\n--wpforms-label-size-font-size: 16px;\n--wpforms-label-size-line-height: 19px;\n--wpforms-label-size-sublabel-font-size: 14px;\n--wpforms-label-size-sublabel-line-height: 17px;\n--wpforms-button-size-font-size: 17px;\n--wpforms-button-size-height: 41px;\n--wpforms-button-size-padding-h: 15px;\n--wpforms-button-size-margin-top: 10px;\n\n\t\t\t\t}\n\t\t\t<\/style><div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-874\"><form id=\"wpforms-form-874\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"874\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/sl\/wp-json\/wp\/v2\/posts\/5257\" data-token=\"bce76f9e08ee65fdfb8f4b35c31c98b3\" data-trp-original-action=\"\/sl\/wp-json\/wp\/v2\/posts\/5257\"><noscript class=\"wpforms-error-noscript\">\u010ce \u017eelite izpolniti ta obrazec, v brskalniku omogo\u010dite JavaScript.<\/noscript><div class=\"wpforms-hidden\" id=\"wpforms-error-noscript\">\u010ce \u017eelite izpolniti ta obrazec, v brskalniku omogo\u010dite JavaScript.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-874-field_3-container\" class=\"wpforms-field wpforms-field-layout\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-874-field_3\" aria-hidden=\"false\">Postavitev<\/label><div class=\"wpforms-field-layout-columns wpforms-field-layout-preset-50-50\"><div class=\"wpforms-layout-column wpforms-layout-column-50\"><div id=\"wpforms-874-field_2-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"2\"><label class=\"wpforms-field-label\" for=\"wpforms-874-field_2\">Ime <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-874-field_2\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][2]\" aria-errormessage=\"wpforms-874-field_2-error\" required><\/div><\/div><div class=\"wpforms-layout-column wpforms-layout-column-50\"><div id=\"wpforms-874-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label\" for=\"wpforms-874-field_1\">E-po\u0161ta <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-874-field_1\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][1]\" spellcheck=\"false\" aria-errormessage=\"wpforms-874-field_1-error\" required><\/div><\/div><\/div><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-turnstile\" ><div class=\"g-recaptcha\" data-sitekey=\"0x4AAAAAAAyrnCk3ccFGBLIG\" data-action=\"FormID-874\"><\/div><input type=\"text\" name=\"g-recaptcha-hidden\" class=\"wpforms-recaptcha-hidden\" style=\"position:absolute!important;clip:rect(0,0,0,0)!important;height:1px!important;width:1px!important;border:0!important;overflow:hidden!important;padding:0!important;margin:0!important;\" data-rule-turnstile=\"1\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"874\"><input type=\"hidden\" name=\"wpforms[author]\" value=\"1\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-874\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Send Inquiry\" aria-live=\"assertive\" value=\"wpforms-submit\">Po\u0161lji povpra\u0161evanje<\/button><img decoding=\"async\" src=\"https:\/\/kelingmed.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Nalaganje\"><\/div><input type=\"hidden\" name=\"trp-form-language\" value=\"sl\"\/><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Distributerji invalidskih vozi\u010dkov, ki \u017eelijo vstopiti na rasto\u010di trg Demokrati\u010dne republike Kongo, morajo razumeti spreminjajo\u010de se predpise o medicinskih pripomo\u010dkih v tej dr\u017eavi. Novi standardi razvr\u0161\u010danja in zahteve za klini\u010dno testiranje so zdaj ovire za skladnost in konkuren\u010dne prednosti. Ta vodnik 2025 pomaga dobaviteljem medicinske opreme, saj prikazuje, kako krmariti regulativna pravila DR Kongo, in ponuja prakti\u010dne metode za pospe\u0161itev certificiranja ob hkratnem zmanj\u0161anju stro\u0161kov.<\/p>","protected":false},"author":1,"featured_media":5259,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[43],"tags":[],"class_list":["post-5257","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-wheelchair"],"amp_enabled":false,"_links":{"self":[{"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/posts\/5257","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/comments?post=5257"}],"version-history":[{"count":4,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/posts\/5257\/revisions"}],"predecessor-version":[{"id":5262,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/posts\/5257\/revisions\/5262"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/media\/5259"}],"wp:attachment":[{"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/media?parent=5257"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/categories?post=5257"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kelingmed.com\/sl\/wp-json\/wp\/v2\/tags?post=5257"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}