{"id":12319,"date":"2021-06-01T13:56:15","date_gmt":"2021-06-01T16:56:15","guid":{"rendered":"https:\/\/www.mscmed.com.br\/?p=12319"},"modified":"2025-05-08T17:39:50","modified_gmt":"2025-05-08T20:39:50","slug":"consulta-publica-agrupamento-de-implantes-ortopedicos","status":"publish","type":"post","link":"https:\/\/www.mscmed.com.br\/en\/2021\/06\/01\/consulta-publica-agrupamento-de-implantes-ortopedicos\/","title":{"rendered":"PUBLIC CONSULTATION: GROUPING OF ORTHOPEDIC IMPLANTS"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"font-family: arial, helvetica, sans-serif;\">We recently published <strong><span style=\"color: #008080;\"><a style=\"color: #008080;\" href=\"https:\/\/www.mscmed.com.br\/en\/2021\/04\/08\/3-dicas-agrupamento-de-placas-e-parafusos-para-ortopedia\/\">here<\/a><\/span><\/strong> tips for grouping orthopedic implants for ANVISA registration purposes. As we highlighted in that opportunity, some rules are very specific and were subject to change.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The good news is that it didn't take long. ANVISA opened a public consultation to determine the new grouping rules for orthopedic implants for registration purposes. RDC 59\/2008 and IN 01\/2009 would be replaced by a new single RDC, whose proposed text can be found in the text of the public consultation.\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Among the highlights of the text proposed in the public consultation are the elimination of the division of plate and screw systems into large\/small and mini\/micro fragments, as well as the express permission for orthopedic suture threads and suture anchors to be registered together with their inserting instruments.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Anyone who wants to view the text in its entirety and leave their opinion can access it at <span style=\"color: #008080;\"><strong><a style=\"color: #008080;\" href=\"http:\/\/antigo.anvisa.gov.br\/consultas-publicas#\/visualizar\/448289)\">public consultation portal (available only in Portuguese).<\/a><\/strong><\/span> of <strong><a href=\"http:\/\/antigo.anvisa.gov.br\/consultas-publicas#\/visualizar\/448289)\"><span style=\"color: #008080;\">ANVISA.<\/span><\/a><\/strong> Contributions will be accepted until 06\/15\/2021.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Recentemente, publicamos aqui dicas para agrupamento de implantes ortop\u00e9dicos para fins de registro ANVISA. Conforme destacamos naquela oportunidade, algumas regras s\u00e3o bem espec\u00edficas e estavam sujeitas \u00e0 mudan\u00e7as. A boa not\u00edcia \u00e9 que n\u00e3o demorou muito. A ANVISA abriu consulta p\u00fablica para determinar as novas regras de agrupamento para implantes ortop\u00e9dicos para fins de registro. A RDC 59\/2008 e a IN 01\/2009 seriam substitu\u00eddas por uma nova RDC \u00fanica, cujo texto proposto encontra-se no texto da consulta p\u00fablica.\u00a0 Entre os destaques do texto proposto na consulta p\u00fablica est\u00e3o a elimina\u00e7\u00e3o da divis\u00e3o de sistemas de placas e parafusos em grandes\/pequenos e mini\/micro fragmentos, bem como a permiss\u00e3o expressa para fios de sutura ortop\u00e9dica e \u00e2ncoras de sutura serem registrados em conjunto com seus instrumentais insersores. Quem quiser visualizar o texto na \u00edntegra e deixar a sua opini\u00e3o pode acess\u00e1-lo no portal de consultas p\u00fablicas da ANVISA. Ser\u00e3o aceitas contribui\u00e7\u00f5es at\u00e9 15\/06\/2021.<\/p>","protected":false},"author":2,"featured_media":12320,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[220,47,73],"tags":[],"class_list":["post-12319","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-implantes-e-produtos-cirurgicos","category-normas-tecnicas","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CONSULTA P\u00daBLICA: AGRUPAMENTO DE IMPLANTES ORTOP\u00c9DICOS - MSC MED<\/title>\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.mscmed.com.br\/en\/2021\/06\/01\/consulta-publica-agrupamento-de-implantes-ortopedicos\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CONSULTA P\u00daBLICA: AGRUPAMENTO DE IMPLANTES ORTOP\u00c9DICOS - MSC MED\" \/>\n<meta property=\"og:description\" content=\"Recentemente, publicamos aqui dicas para agrupamento de implantes ortop\u00e9dicos para fins de registro ANVISA. Conforme destacamos naquela oportunidade, algumas regras s\u00e3o bem espec\u00edficas e estavam sujeitas \u00e0 mudan\u00e7as. A boa not\u00edcia \u00e9 que n\u00e3o demorou muito. A ANVISA abriu consulta p\u00fablica para determinar as novas regras de agrupamento para implantes ortop\u00e9dicos para fins de registro. A RDC 59\/2008 e a IN 01\/2009 seriam substitu\u00eddas por uma nova RDC \u00fanica, cujo texto proposto encontra-se no texto da consulta p\u00fablica.\u00a0 Entre os destaques do texto proposto na consulta p\u00fablica est\u00e3o a elimina\u00e7\u00e3o da divis\u00e3o de sistemas de placas e parafusos em grandes\/pequenos e mini\/micro fragmentos, bem como a permiss\u00e3o expressa para fios de sutura ortop\u00e9dica e \u00e2ncoras de sutura serem registrados em conjunto com seus instrumentais insersores. Quem quiser visualizar o texto na \u00edntegra e deixar a sua opini\u00e3o pode acess\u00e1-lo no portal de consultas p\u00fablicas da ANVISA. 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Conforme destacamos naquela oportunidade, algumas regras s\u00e3o bem espec\u00edficas e estavam sujeitas \u00e0 mudan\u00e7as. A boa not\u00edcia \u00e9 que n\u00e3o demorou muito. A ANVISA abriu consulta p\u00fablica para determinar as novas regras de agrupamento para implantes ortop\u00e9dicos para fins de registro. A RDC 59\/2008 e a IN 01\/2009 seriam substitu\u00eddas por uma nova RDC \u00fanica, cujo texto proposto encontra-se no texto da consulta p\u00fablica.\u00a0 Entre os destaques do texto proposto na consulta p\u00fablica est\u00e3o a elimina\u00e7\u00e3o da divis\u00e3o de sistemas de placas e parafusos em grandes\/pequenos e mini\/micro fragmentos, bem como a permiss\u00e3o expressa para fios de sutura ortop\u00e9dica e \u00e2ncoras de sutura serem registrados em conjunto com seus instrumentais insersores. Quem quiser visualizar o texto na \u00edntegra e deixar a sua opini\u00e3o pode acess\u00e1-lo no portal de consultas p\u00fablicas da ANVISA. 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