{"id":3262,"date":"2020-06-26T14:35:03","date_gmt":"2020-06-26T12:35:03","guid":{"rendered":"http:\/\/www.cechova.sk\/?p=3262"},"modified":"2020-06-29T08:16:44","modified_gmt":"2020-06-29T06:16:44","slug":"navrat-vnutrostatnej-upravy-zdravotnickych-pomocok","status":"publish","type":"post","link":"https:\/\/www.cechova.sk\/sk\/navrat-vnutrostatnej-upravy-zdravotnickych-pomocok\/","title":{"rendered":"N\u00e1vrat vn\u00fatro\u0161t\u00e1tnej \u00fapravy zdravotn\u00edckych pom\u00f4cok"},"content":{"rendered":"<p><span style=\"font-family: georgia, palatino, serif; font-size: 12pt;\">23. j\u00fana 2020 nadobudla \u00fa\u010dinnos\u0165 novela Z\u00e1kona o liekoch a zdravotn\u00edckych pom\u00f4ckach, ktor\u00e1 do z\u00e1kona vr\u00e1tila vn\u00fatro\u0161t\u00e1tnu pr\u00e1vnu \u00fapravu zdravotn\u00edckych pom\u00f4cok. T\u00e1to pr\u00e1vna \u00faprava bola p\u00f4vodne zru\u0161en\u00e1 s \u00fa\u010dinnos\u0165ou od 26. m\u00e1ja 2020, kedy malo nadobudn\u00fa\u0165 \u00fa\u010dinnos\u0165 nariadenie E\u00da o zdravotn\u00edckych pom\u00f4ckach. \u00da\u010dinnos\u0165 eur\u00f3pskeho nariadenia bola pre pand\u00e9miu COVID-19 odlo\u017een\u00e1 o rok, na \u010do v\u0161ak slovensk\u00fd z\u00e1konodarca nestihol v\u010das zareagova\u0165, a tak bola oblas\u0165 zdravotn\u00edckych pom\u00f4cok v Slovenskej republike takmer mesiac bez regul\u00e1cie.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif; font-size: 12pt;\">Ustanovenia upravuj\u00face z\u00e1kladn\u00e9 pojmy pre oblas\u0165 zdravotn\u00edckych pom\u00f4cok, internetov\u00fd v\u00fddaj, registr\u00e1ciu a evidenciu v\u00fdrobcu zdravotn\u00edckej pom\u00f4cky, klinick\u00e9 sk\u00fa\u0161anie zdravotn\u00edckych pom\u00f4cok, uvedenie zdravotn\u00edckej pom\u00f4cky na trh alebo do prev\u00e1dzky, postupy pri nespr\u00e1vnom alebo ch\u00fdbaj\u00facom ozna\u010den\u00ed zna\u010dkou zhody CE, opatrenia na ochranu zdravia a bezpe\u010dnosti pou\u017e\u00edvania, ml\u010danlivos\u0165 a d\u00f4vernos\u0165, zaznamen\u00e1vanie a evidenciu nehody, poruchy a zlyhania zdravotn\u00edckej pom\u00f4cky po jej uveden\u00ed na trh, ktor\u00e9 sa uplat\u0148uj\u00fa so sp\u00e4tnou \u00fa\u010dinnos\u0165ou od 26. m\u00e1ja 2020 do 25. m\u00e1ja 2021, kedy m\u00e1 nadobudn\u00fa\u0165 \u00fa\u010dinnos\u0165 odlo\u017een\u00e9 nariadenie E\u00da o\u00a0zdravotn\u00edckych pom\u00f4ckach, s\u00fa uveden\u00e9 v\u00a0prechodn\u00fdch ustanoveniach Z\u00e1kona o\u00a0liekoch a\u00a0zdravotn\u00edckych pom\u00f4ckach, v \u00a7\u00a7 143k a\u017e 143t.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif; font-size: 12pt;\">Z\u00e1rove\u0148 s\u00a0novelou Z\u00e1kona o\u00a0liekoch a\u00a0zdravotn\u00edckych pom\u00f4ckach boli znovu vydan\u00e9 a op\u00e4tovne nadobudli \u00fa\u010dinnos\u0165 aj vykon\u00e1vacie predpisy v\u00a0oblasti zdravotn\u00edckych pom\u00f4cok: Nariadenie vl\u00e1dy, ktor\u00fdm sa ustanovuj\u00fa podrobnosti o technick\u00fdch po\u017eiadavk\u00e1ch a postupoch posudzovania zhody zdravotn\u00edckych pom\u00f4cok, a Nariadenie vl\u00e1dy, ktor\u00fdm sa ustanovuj\u00fa podrobnosti o technick\u00fdch po\u017eiadavk\u00e1ch a postupoch posudzovania zhody akt\u00edvnych implantovate\u013en\u00fdch zdravotn\u00edckych pom\u00f4cok.<\/span><\/p>\n<p><span style=\"font-family: georgia, palatino, serif; font-size: 12pt;\">Ak sa chcete dozvedie\u0165 viac, kontaktuje na\u0161ich kolegov Marka Holku a Tom\u00e1\u0161a Ryb\u00e1ra.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>23. j\u00fana 2020 nadobudla \u00fa\u010dinnos\u0165 novela Z\u00e1kona o liekoch a zdravotn\u00edckych pom\u00f4ckach, ktor\u00e1 do z\u00e1kona vr\u00e1tila vn\u00fatro\u0161t\u00e1tnu pr\u00e1vnu \u00fapravu zdravotn\u00edckych&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"episode_type":"","audio_file":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","filesize_raw":"","footnotes":""},"categories":["1","2","11","12","20","21","32","33"],"class_list":{"0":"post-3262","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"hentry","6":"category-dalsie-publikacie","8":"category-financial-law-news","9":"category-european-community-law-news","10":"category-aktuality","11":"category-pravne-novinky"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>N\u00e1vrat vn\u00fatro\u0161t\u00e1tnej \u00fapravy zdravotn\u00edckych pom\u00f4cok - \u010cechov\u00e1 &amp; Partners<\/title>\n<meta name=\"description\" content=\"N\u00e1vra\u0165 vn\u00fatro\u0161t\u00e1tnej \u00fapravy zdravotn\u00edckych pom\u00f4cok. 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