{"id":20934,"date":"2022-05-30T13:53:12","date_gmt":"2022-05-30T11:53:12","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20934"},"modified":"2022-05-30T13:53:12","modified_gmt":"2022-05-30T11:53:12","slug":"brazil-rdc-665-2022-brazilian-good-manufacturing-pratices-bgmp-application","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/05\/30\/brazil-rdc-665-2022-brazilian-good-manufacturing-pratices-bgmp-application\/","title":{"rendered":"BRAZIL: RDC 665\/2022 for Brazilian Good Manufacturing Practice (BGMP) application"},"content":{"rendered":"\n<p><strong>ANVISA<\/strong> -Brazilian Regulatory Authority &#8211; published the <strong>RDC 665\/2022<\/strong> (entered into force last 2May 2022). This resolution rewrites the <strong>BGMP<\/strong> <strong>(Brazilian Good Manufacturing Practices)<\/strong> <strong>requirements<\/strong> for medical devices and IVDs, becoming now the reference point for the adaptation of the Quality Management System of Manufacturers who place their devices on the Brazilian territory, both with and without adhering to MDSAP program.<\/p>\n\n\n\n<p>RDC 665\/2022 replaces the resolution RDC 16\/2013 and the IN 08\/2013.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/05\/brasile-rdc-665-2022-bgmp-1-1024x535.jpg\" alt=\"BRAZIL: DRC 665\/2022 for Brazilian Good Manufacturing Practice (BGMP) application\" class=\"wp-image-20935\"\/><figcaption>BRAZIL: RDC 665\/2022 for Brazilian Good Manufacturing Practices (BGMP) application<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What are the RDC 665\/2022 requirements <\/strong><\/h2>\n\n\n\n<p>Resolution RDC\n665\/2022 defines the Brazilian Quality Management System (QMS) requirements\nthat must be followed regarding methods, controls and other processes related\nto the design, purchase and manufacture of medical devices and IVDs.<\/p>\n\n\n\n<p>Among the most\nimportant are: the obligation to establish responsibilities, authorities and\ninterrelation of all personnel managing and verifying the Quality Management System\nin the company; the necessity to establish the proof that the Suppliers have\nreceived the specifications for goods and supplied services; and the extension\nto the Importers of label and IFU control.<\/p>\n\n\n\n<p>The BGMP introduced by\nresolution RDC 665\/2022 apply to Manufacturers and Importers, as well as to distributors\nand retailers operating in Brazil. The entry into force of this resolution\nmakes it necessary to adapt the Quality Management System of the MDSAP\ncertified organization or of the company that simply exports the devices on the\nterritory, to the updated requirements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Does your company\nmarket medical devices in Brazil?<\/strong><\/h2>\n\n\n\n<p>We remind you that if your organization is <strong>MDSAP certified<\/strong> for the Brazilian market or markets devices in Brazil, you will have to apply the BGMP RDC 665\/2022 provisions and its regulatory requirements in order to be ready for next MDSAP or ANVISA inspection.<\/p>\n\n\n\n<p><strong>Choose Thema as\nyour trusted partner<\/strong> for the adaptation of your Quality Management System to the BGMP\nrequirements now in force and you will be able to market your devices quickly\nand in full compliance with the regulatory requirements.<\/p>\n\n\n\n<p>Our Customer Service is at your complete disposal: <a href=\"mailto:sales@thema-med.com\"><strong>contact us for further information<\/strong><\/a><strong>!<\/strong><\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"http:\/\/antigo.anvisa.gov.br\/documents\/10181\/6415268\/RDC_665_2022_.pdf\/100f65fb-335c-459f-aa1c-b30c995dc9d9\">RDC 665\/2022, Ag\u00eancia Nacional de\nVigil\u00e2ncia Sanit\u00e1ria (ANVISA), 30 marzo 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ANVISA -Brazilian Regulatory Authority &#8211; published the RDC 665\/2022 (entered into force last 2May 2022). This resolution rewrites the BGMP (Brazilian  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-20934","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRAZIL: Brazilian Good Manufacturing Practices (BGMP) application<\/title>\n<meta name=\"description\" content=\"ANVISA published the RDC 665\/2022. This resolution rewrites the BGMP (Brazilian Good Manufacturing Practices) requirements for medical devices and IVDs\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2022\/05\/30\/brazil-rdc-665-2022-brazilian-good-manufacturing-pratices-bgmp-application\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BRAZIL: Brazilian Good Manufacturing Practices (BGMP) application\" \/>\n<meta property=\"og:description\" content=\"ANVISA published the RDC 665\/2022. 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