TBT BSN | Notification

Notification Detail :: G/TBT/N/BRA/929/Add.2

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Draft resolution number 734, 22 October 2019.

Objective

Protection of human health or safety (TBT)

Product Covered

HS Code(s): 3002300, 3822 (In vitro diagnosis products)

Document Notification

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HSCODE

300230 - Vaccines for veterinary medicine; 3822 - Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, and certified reference materials (excl. compound diagnostic reagents designed to be administered to the patient, blood-grouping reagents, animal blood prepared for therapeutic, prophylactic or diagnostic uses and vaccines, toxins, cultures of micro-organisms and similar products); 300230 - Vaccines for veterinary medicine; 3822 - Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 30.02 or 30.06; certified reference materials.

ICSCODE

11.100.10 - In vitro diagnostic test systems; 11.100.10 - In vitro diagnostic test systems

Keywords

Labelling; Labelling

Specific Regions

Description

The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was adopted as Resolution 830, 6 December 2023.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9

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/929/Add.2

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