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.