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

Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref. : EIC 413/3

24 March 2022

Dear Sirs,

Commercial Information Circular No. 245/2022

Brazil : New Regulation on Importation and Commercialisation of Used and Refurbished Medical Devices

The National Health Agency ("Agência Nacional de Vigilância Sanitária" in Portuguese/ ANVISA) of Brazil issued Resolution RDC No. 579/2021 on the new regulation on the importation and commercialisation of used and refurbished medical devices for use in Brazil effective on 1 January 2022. Among other requirements, used medical devices for professional use must be commercialised with an indelible label that allows the product to be tracked and shows the ANVISA authorisation number. Only ANVISA-authorised entities will be allowed to commercialise these products.

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: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-579-de-25-de-novembro-de-2021-363480054.

ENQUIRIES

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

Yours faithfully,

(Ms Sandra 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.