{"id":1344,"date":"2026-05-23T08:00:00","date_gmt":"2026-05-23T11:00:00","guid":{"rendered":"https:\/\/sevenresiduosaude.com.br\/blog\/?p=1344"},"modified":"2026-05-23T08:00:00","modified_gmt":"2026-05-23T11:00:00","slug":"notivisa-pgrss-passo-a-passo-evento-adverso","status":"publish","type":"post","link":"https:\/\/sevenresiduosaude.com.br\/blog\/notivisa-pgrss-passo-a-passo-evento-adverso\/","title":{"rendered":"NOTIVISA + PGRSS \u2014 passo a passo evento adverso"},"content":{"rendered":"

Por que NOTIVISA \u00e9 obrigat\u00f3rio no PGRSS<\/h2>\n

NOTIVISA = Sistema Nacional de Notifica\u00e7\u00f5es em Vigil\u00e2ncia Sanit\u00e1ria<\/strong> (notivisa.anvisa.gov.br). Toda cl\u00ednica\/hospital deve notificar eventos adversos relacionados a produtos de sa\u00fade<\/strong> em 72h da ci\u00eancia. PGRSS gera 4 categorias notific\u00e1veis: OPME defeituosa retornada<\/strong> + medicamento vencido encontrado em estoque<\/strong> + evento adverso transfusional<\/strong> + acidente com fonte radioativa Grupo C<\/strong>. Falha de notifica\u00e7\u00e3o = auto ANVISA + perda alvar\u00e1. RDC 67\/2009 + RDC 4\/2009 + RDC 296\/2019.<\/p>\n

Tabela 5 eventos PGRSS notific\u00e1veis NOTIVISA<\/h2>\n\n\n\n\n\n\n\n\n\n
Evento<\/th>\nPrazo<\/th>\nFormul\u00e1rio<\/th>\nAnexo<\/th>\n<\/tr>\n<\/thead>\n
OPME defeituosa (stent, pr\u00f3tese, implante)<\/td>\n72h ci\u00eancia<\/td>\nTecnovigil\u00e2ncia<\/td>\nfoto + lote + RT<\/td>\n<\/tr>\n
Medicamento vencido em uso<\/td>\n72h ci\u00eancia<\/td>\nFarmacovigil\u00e2ncia<\/td>\nlote + foto + paciente<\/td>\n<\/tr>\n
Evento transfusional adverso<\/td>\n24h rea\u00e7\u00e3o<\/td>\nHemovigil\u00e2ncia<\/td>\nlote + paciente + tipagem<\/td>\n<\/tr>\n
Acidente fonte radioativa<\/td>\nimediato<\/td>\nSangue + radia\u00e7\u00e3o<\/td>\ndos\u00edmetro + CNEN<\/td>\n<\/tr>\n
Cosm\u00e9tico com rea\u00e7\u00e3o al\u00e9rgica grave<\/td>\n72h<\/td>\nCosmetovigil\u00e2ncia<\/td>\nlote + foto<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Cap\u00edtulo 6 passos NOTIVISA + PGRSS<\/h2>\n

Procedimento operacional:<\/p>\n

    \n
  1. Identifica\u00e7\u00e3o<\/strong> evento adverso pela equipe (RT informado em \u226424h)<\/li>\n
  2. Triagem<\/strong> \u2014 confirmar relacionado a produto + nexo causal<\/li>\n
  3. Cadastro<\/strong> notivisa.anvisa.gov.br via login institucional gov.br\/CNES<\/li>\n
  4. Anexar<\/strong> lote + foto + lote rastre\u00e1vel + paciente anonimizado<\/li>\n
  5. Resposta ANVISA<\/strong> 5-30 dias \u00fateis (eventual visita)<\/li>\n
  6. Arquivo digital<\/strong> + impress\u00e3o + ata 5 anos m\u00ednimo<\/li>\n<\/ol>\n

    3 perfis impacto<\/h2>\n

    Cl\u00ednica MEI:<\/strong> raros eventos (1-3\/ano). Custo treinamento R$ 200-500.<\/p>\n

    Cl\u00ednica m\u00e9dia:<\/strong> 5-15 eventos\/ano. RT dedicado R$ 800-1500\/m\u00eas.<\/p>\n

    Hospital:<\/strong> 30-100+ eventos\/ano. Equipe vigil\u00e2ncia R$ 4-10k\/m\u00eas.<\/p>\n

    3 erros frequentes<\/h2>\n
      \n
    1. Notificar fora prazo (>72h) \u2014 auto + suspens\u00e3o<\/li>\n
    2. Sem anexar lote\/foto \u2014 invalida processo<\/li>\n
    3. Sem arquivo 5 anos \u2014 descumpre RDC 296<\/li>\n<\/ol>\n

      Solicite consultoria NOTIVISA + PGRSS<\/a><\/strong> \u2014 cap\u00edtulo tecnovigil\u00e2ncia + farmacovigil\u00e2ncia + hemovigil\u00e2ncia.<\/p>\n","protected":false},"excerpt":{"rendered":"

      Fluxo NOTIVISA evento adverso PGRSS: notifica\u00e7\u00e3o 72h, formul\u00e1rio, anexo, acompanhamento ANVISA.<\/p>\n","protected":false},"author":3,"featured_media":1343,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[274,2269,1828,22],"class_list":["post-1344","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-legislacao","tag-anvisa","tag-evento-adverso","tag-notivisa","tag-rdc-222"],"_links":{"self":[{"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/posts\/1344","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/comments?post=1344"}],"version-history":[{"count":1,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/posts\/1344\/revisions"}],"predecessor-version":[{"id":3913,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/posts\/1344\/revisions\/3913"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/media\/1343"}],"wp:attachment":[{"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/media?parent=1344"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/categories?post=1344"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sevenresiduosaude.com.br\/blog\/wp-json\/wp\/v2\/tags?post=1344"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}