Brazil : Various Requirements Concerning Customised Medical Devices

tradecircular

19-12-2024

24-hour hotline : 23 922 922

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

Ref. : EIC 413/3

19 December 2024

Dear Sirs,

Commercial Information Circular No. 1048/2024

Brazil : Various Requirements Concerning Customised Medical Devices

The National Health Agency ("Agência Nacional de Vigilância Sanitária" in Portuguese/ ANVISA) of Brazil issued Collegiate Board Resolution RDC 925/2024 to set forth requirements for the manufacture, marketing, import and exposure to use of customised medical devices. For details, traders are advised to consult their importers in Brazil and/or refer to the Board Resolution (in Portuguese) available at:

https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000925&seqAto=000&valorAno=2024&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true.

ENQUIRIES

2.For enquiries concerning the content of this circular, please contact us at telephone number 2398 5405.

Yours faithfully,

(Dixon FUNG)
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.

2024-12-20

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