BR – Plano de Ação de Pesquisa Clínica no Brasil (in Portuguese)
Published in Brasil, Clinical Investigation and Clinical Trial
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- Free emergency regulatory service – Medical device registration in Brazil
- Serviço gratuito em caráter emergencial – Registro de dispositivos médicos no Brasil
- Brasil – DECRETO Nº 10.229, DE 5 DE FEVEREIRO DE 2020 (in Portuguese)
- Brazil – ANVISA RDC Nº 336, DE 30 DE JANEIRO DE 2020 – Deadlines for ANVISA response
- ANVISA – CONSULTA PÚBLICA Nº 734, DE 22 DE OUTUBRO DE 2019 – Registro de dispositivos médicos para diagnóstico in vitro (in vitro diagnostic medical mevices registration)
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- EU – MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
- EU – MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
- US – FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
- FDIS of ISO 14155:2020 (edition 3)
- MHRA Revised Guidance – Clinical investigations of medical devices – guidance for manufacturers
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- US – FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
- FDIS of ISO 14155:2020 (edition 3)
- MHRA Revised Guidance – Clinical investigations of medical devices – guidance for manufacturers
- IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
- Grey literature and medical devices
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