Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref. : EIC 413/3
18 May 2023
Dear Sirs,
Commercial Information Circular No. 341/2023
Brazil : New Filing Requirements for Imported Medical Devices
The National Health Agency ("Agência Nacional de Vigilância Sanitária" in Portuguese/ ANVISA) of Brazil recently issued a press release reminding stakeholders that the new filing requirements for imported medical devices entered into force on 17 April 2023. The relevant press release (in Portuguese) is at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-orienta-sobre-protocolo-para-importacao-de-dispositivos-medicos.
2.For details of the Brazilian measures and the products involved, traders are advised to consult their importers in Brazil and/or the relevant Brazilian Resolution (in Portuguese) which is available at: http://antigo.anvisa.gov.br/documents/10181/2718376/%288%29RDC_81_2008_COMP.pdf/c7d32e84-98d9-47ce-9551-7e6f06110830.
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.