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brazil, cadastre process (simplified registration), infusion pumps and devices, inmetro certification process, inmetro mark (brazilian conformity mark), syringes
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Old 5th January 2012, 10:45 AM
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Look! INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets

Hello all

Continuing the trend of Anvisa using INmetro certification as a means to verify some claims of safety and efficacy of medical devices, Inmetro published last week 3 new regulations - certification for syringes, needles and infusion sets.

The certification process uses Type 5 (the same as medical equipment certification) or type 7 (batch) iso certifications ans will required prior to registrations/cadastre of these devices. They also uses ISO standards for type testing.

In portuguese, on the following links:

Portaria INMETRO / MDIC número 501 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Agulhas Hipodérmicas Estéreis para Uso Único e Agulhas Gengivais Estéreis para Uso Único

Portaria INMETRO / MDIC número 502 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Equipos de Uso Único de Transfusão, de Infusão Gravitacional e de Infusão para Uso com Bomba de Infusão

Portaria INMETRO / MDIC número 503 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Seringas Hipodérmicas Estéreis de Uso Único

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Old 16th August 2012, 12:16 PM
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Re: INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets

Thanks Marcello for this information.
Looks like we have to expect a bunch of other products requiring the certification in the next future, isn't it?
How do I find the OCB that has the equipment performing the tests?
The scopes may just say "non-active products"...Can I find a comprehensive list of medical devices with mandatory INMETRO Certification?

I also found this N° 162 of 2012 (RTAC001804.pdf) on breast implants... Do the OCB provide tests on the breast implants?
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