Brazil | Resolution 837, 13 December 2023 b| Clinical trials with medical devices

Title of document
Draft resolution number 1123, 27 October 2022;

Description
Draft resolution number 1123, 27 October 2022 - previously notified through G/TBT/N/BRA/1458  - which contains provisions on the performance of clinical trials with medical devices in Brazi, was adopted as Resolution 837, 13 December 2023. The final text is available only in Portuguese and can be downloaded at: https://antigo.anvisa.gov.br/documents/10181/6478920/RDC_837_2023_.pdf/d76982bf-db7c-43c8-9e1f-35b3c1bee159

Notifying member: Brazil

Notification: G/TBT/N/BRA/1458/Add.1

Objective tag
Protection of human health or safety (TBT)

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 04/01/2024
• Final date for comments: N/A
• Proposed date of adoption: N/A