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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref. : EIC 413/3

18 January 2024

Dear Sirs,

Commercial Information Circular No. 84/2024

Brazil : Updated Requirements for In Vitro Diagnostic Medical Devices

The National Health Agency ("Agência Nacional de Vigilância Sanitária" in Portuguese/ ANVISA) of Brazil issued Collegiate Board Resolution RDC 830/2023 to update the requirements for in vitro diagnostic medical devices. The updated requirement will take effect from 1 June 2024.

2.For details, traders are advised to consult their importers in Brazil and/or the relevant Brazilian Resolution and Press Release (in Portuguese) available at:

Resolution No. 830/2023
https://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9

Press Release:
https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-atualiza-regras-sobre-dispositivos-medicos-para-diagnostico-in-vitro

ENQUIRIES

3.For enquiries concerning the content of this circular, please contact Miss K Y HO at telephone number 2398 5405.

Yours faithfully,

(Miss Priscilla MOK)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.