TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/1458/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft resolution number 1123, 27 October 2022;

Objective

Protection of human health or safety (TBT)

Product Covered

Medical equipment (ICS code(s): 11.040)

Document Notification

Link to ePing

HSCODE

ICSCODE

11.040 - Medical equipment; 11.040 - Medical equipment

Keywords

Human health; Human health

Specific Regions

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

Notified Document

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/BRA/1458/Add.1

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