{"id":4405728,"date":"2024-04-18T14:22:00","date_gmt":"2024-04-18T19:22:00","guid":{"rendered":"https:\/\/www.olartemoure.com\/?p=4405728"},"modified":"2024-06-20T09:24:38","modified_gmt":"2024-06-20T14:24:38","slug":"pharma-and-medical-device-regulation-2024","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/pharma-and-medical-device-regulation-2024\/","title":{"rendered":"Pharma and medical device regulation &#8211; Lexology 2024"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; _builder_version=&#8221;4.22.2&#8243; custom_padding=&#8221;0px||0px||true|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.22.2&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; width=&#8221;100%&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221; theme_builder_area=&#8221;et_body_layout&#8221;][et_pb_text admin_label=&#8221;Text&#8221; _builder_version=&#8221;4.25.0&#8243; text_font=&#8221;|700|||||||&#8221; text_text_color=&#8221;#003366&#8243; text_font_size=&#8221;1.3em&#8221; text_line_height=&#8221;1.5em&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2 style=\"color:#003366; font-weight:bolder; line-height:1.5em;\">A Clear Guide for the Regulation of the Pharma and Medical Device Industry in Colombia<\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;1.2em&#8221; text_line_height=&#8221;1.5em&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221; sticky_enabled=&#8221;0&#8243; text_orientation=&#8221;justified&#8221;]<\/p>\n<p>The National Food and Drug Surveillance Institute (INVIMA) is the competent authority for granting marketing authorisation for medical devices, medicinal products, cosmetics and dietary products, and for the surveillance of manufacturing facilities by issuing good laboratory practices and good manufacturing practice certi\u2018cation. INVIMA also has the administrative authority to investigate and punish violations of sanitary rules, examine over-the-counter drug advertising, and control prescription drug advertising.<\/p>\n<p>Products monitored by INVIMA are classi\u2018ed according to the de\u2018nitions provided by regulatory law. For example, \u2019medical devicesq are de\u2018ned as any instrument, apparatus, machine, software, biomedical e:uipment or other similar or related articles, whether used alone or in combination, including components, parts, accessories and software necessary for proper application<\/p>\n<p>[\/et_pb_text][dsm_button button_one_text=&#8221;Download it here!&#8221; button_one_url=&#8221;https:\/\/www.olartemoure.com\/wp-content\/uploads\/2024\/05\/Colombia-Pharma-Medical-Device-Regulation.pdf&#8221; button_one_url_new_window=&#8221;on&#8221; _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221; sticky_enabled=&#8221;0&#8243;][\/dsm_button][et_pb_text _builder_version=&#8221;4.25.0&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;1.2em&#8221; text_line_height=&#8221;1.5em&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;et_body_layout&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>If you need more details or help with any specific case<a href=\"https:\/\/www.olartemoure.com\/en\/contactenos\/\" target=\"_blank\" rel=\"noopener\"> contact us<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In this new edition of the Pharma &#038; Medical Device Regulation we share our contributions to the Colombian chapter.<\/p>\n","protected":false},"author":5,"featured_media":4399960,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:divi\/placeholder \/-->","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1092,109],"tags":[],"class_list":["post-4405728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-contributions","category-regulatory-affairs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pharma and medical device regulation - Lexology 2024 - OlarteMoure | Intellectual Property<\/title>\n<meta name=\"description\" content=\"In this new edition of the Pharma &amp; 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