{"id":12341,"date":"2022-02-15T06:00:38","date_gmt":"2022-02-15T09:00:38","guid":{"rendered":"https:\/\/www.mscmed.com.br\/?p=12341"},"modified":"2025-05-08T17:26:46","modified_gmt":"2025-05-08T20:26:46","slug":"atencao-para-a-revalidacao-de-registros","status":"publish","type":"post","link":"https:\/\/www.mscmed.com.br\/en\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/","title":{"rendered":"ATTENTION FOR RECORD REVALIDATION"},"content":{"rendered":"

In January 2018, the validity of medical device registrations increased from 5 years to 10 years, after the publication of RDC 211\/2018. Thus, the registrations granted or revalidated in 2013, which would need to be revalidated in 2018, as the period of 05 years would expire, had their validity extended to 10 years. Thus, only in 2023 would it be necessary to renew them.<\/span><\/p>\n

This means that ANVISA has not received a single request for revalidation of medical device registration for five years. That's about to change.<\/span><\/p>\n

The deadline for requesting registration revalidation is between 6 months and 12 months in advance of the expiration date. Thus, records expiring in 2023 may have already applied for revalidation.<\/span><\/p>\n

However, ATTENTION!<\/strong><\/span><\/span><\/p>\n

Since 2013, a lot has changed, and it is important to REVIEW the records for submitting the revalidation request. Some rules have changed and it is important to note them before submitting requests to renew your registrations. We suggest that this analysis be done in advance!<\/span><\/p>\n

Some issues worth reviewing and updating when submitting your revalidation request:<\/span><\/p>\n

    \n
  1. Clinical Evaluation<\/span><\/li>\n
  2. Risk management<\/span><\/li>\n
  3. Performance and stability tests<\/span><\/li>\n
  4. Grouping for sanitary registration<\/span><\/li>\n<\/ol>\n

    MSC MED will conduct a task force to review records that will expire in 2023. If you have records in your portfolio in this situation, please do not hesitate to contact us.<\/span><\/p>","protected":false},"excerpt":{"rendered":"

    Em Janeiro de 2018, a validade dos registros de dispositivos m\u00e9dicos passou de 05 anos para 10 anos, ap\u00f3s a publica\u00e7\u00e3o da RDC 211\/2018. Assim, os registros concedidos ou revalidados em 2013, que iriam precisar ser revalidados em 2018, j\u00e1 que iria vencer o prazo de 05 anos, tiveram a sua validade estendida para 10 anos. Assim, apenas em 2023 seria necess\u00e1rio renov\u00e1-los. Isso significa que h\u00e1 cinco anos a ANVISA n\u00e3o recebe um \u00fanico pedido de revalida\u00e7\u00e3o de registro de dispositivos m\u00e9dicos. Isso est\u00e1 prestes a mudar. O prazo para a solicita\u00e7\u00e3o de revalida\u00e7\u00e3o de registro \u00e9 de entre 06 meses a 12 meses de anteced\u00eancia em rela\u00e7\u00e3o ao vencimento. Assim, os registros vencendo em 2023 j\u00e1 podem ter solicitado o pedido de revalida\u00e7\u00e3o. Por\u00e9m, ATEN\u00c7\u00c3O! De 2013 para c\u00e1 muita coisa mudou, e \u00e9 importante REVISAR os registros para a submiss\u00e3o do pedido de revalida\u00e7\u00e3o. Algumas regras mudaram e \u00e9 importante not\u00e1-las antes de submeter os pedidos para renovar os seus registros. Sugerimos que essa an\u00e1lise seja feita com anteced\u00eancia! Algumas quest\u00f5es que valem a pena serem revisadas e atualizadas na submiss\u00e3o do seu pedido de revalida\u00e7\u00e3o: Avalia\u00e7\u00e3o Cl\u00ednica Gerenciamento de Riscos Ensaios de performance e estabilidade Agrupamento para registro sanit\u00e1rio A MSC MED ir\u00e1 realizar uma for\u00e7a-tarefa de revis\u00e3o de registros que ir\u00e3o vencer em 2023. Se voc\u00ea tem em seu portf\u00f3lio registros nessa situa\u00e7\u00e3o, n\u00e3o deixe de fazer contato conosco.<\/p>","protected":false},"author":1,"featured_media":12348,"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":[218,225,222],"tags":[],"class_list":["post-12341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dicas","category-equipamentos-medicos","category-regulacao-e-certificacao"],"yoast_head":"\nATEN\u00c7\u00c3O PARA A REVALIDA\u00c7\u00c3O DE REGISTROS - 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\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ATEN\u00c7\u00c3O PARA A REVALIDA\u00c7\u00c3O DE REGISTROS - MSC MED\" \/>\n<meta property=\"og:description\" content=\"Em Janeiro de 2018, a validade dos registros de dispositivos m\u00e9dicos passou de 05 anos para 10 anos, ap\u00f3s a publica\u00e7\u00e3o da RDC 211\/2018. Assim, os registros concedidos ou revalidados em 2013, que iriam precisar ser revalidados em 2018, j\u00e1 que iria vencer o prazo de 05 anos, tiveram a sua validade estendida para 10 anos. Assim, apenas em 2023 seria necess\u00e1rio renov\u00e1-los. Isso significa que h\u00e1 cinco anos a ANVISA n\u00e3o recebe um \u00fanico pedido de revalida\u00e7\u00e3o de registro de dispositivos m\u00e9dicos. Isso est\u00e1 prestes a mudar. O prazo para a solicita\u00e7\u00e3o de revalida\u00e7\u00e3o de registro \u00e9 de entre 06 meses a 12 meses de anteced\u00eancia em rela\u00e7\u00e3o ao vencimento. Assim, os registros vencendo em 2023 j\u00e1 podem ter solicitado o pedido de revalida\u00e7\u00e3o. Por\u00e9m, ATEN\u00c7\u00c3O! De 2013 para c\u00e1 muita coisa mudou, e \u00e9 importante REVISAR os registros para a submiss\u00e3o do pedido de revalida\u00e7\u00e3o. Algumas regras mudaram e \u00e9 importante not\u00e1-las antes de submeter os pedidos para renovar os seus registros. Sugerimos que essa an\u00e1lise seja feita com anteced\u00eancia! Algumas quest\u00f5es que valem a pena serem revisadas e atualizadas na submiss\u00e3o do seu pedido de revalida\u00e7\u00e3o: Avalia\u00e7\u00e3o Cl\u00ednica Gerenciamento de Riscos Ensaios de performance e estabilidade Agrupamento para registro sanit\u00e1rio A MSC MED ir\u00e1 realizar uma for\u00e7a-tarefa de revis\u00e3o de registros que ir\u00e3o vencer em 2023. Se voc\u00ea tem em seu portf\u00f3lio registros nessa situa\u00e7\u00e3o, n\u00e3o deixe de fazer contato conosco.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.mscmed.com.br\/en\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\" \/>\n<meta property=\"og:site_name\" content=\"MSC MED\" \/>\n<meta property=\"article:published_time\" content=\"2022-02-15T09:00:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-08T20:26:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.mscmed.com.br\/wp-content\/uploads\/2022\/02\/BANNER-BLOG_REVALIDACAO-REGISTRO.png\" \/>\n\t<meta property=\"og:image:width\" content=\"873\" \/>\n\t<meta property=\"og:image:height\" content=\"364\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/www.mscmed.com.br\/#\/schema\/person\/89b5e3be900bb1089fd668003da80f9d\"},\"headline\":\"ATEN\u00c7\u00c3O PARA A REVALIDA\u00c7\u00c3O DE REGISTROS\",\"datePublished\":\"2022-02-15T09:00:38+00:00\",\"dateModified\":\"2025-05-08T20:26:46+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\"},\"wordCount\":257,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.mscmed.com.br\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.mscmed.com.br\/wp-content\/uploads\/2022\/02\/BANNER-BLOG_REVALIDACAO-REGISTRO.png\",\"articleSection\":[\"Dicas\",\"Equipamentos M\u00e9dicos\",\"Regula\u00e7\u00e3o e Certifica\u00e7\u00e3o\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\",\"url\":\"https:\/\/www.mscmed.com.br\/2022\/02\/15\/atencao-para-a-revalidacao-de-registros\/\",\"name\":\"ATEN\u00c7\u00c3O PARA A REVALIDA\u00c7\u00c3O DE REGISTROS - 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