Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil

Hi all,

We are medical manufacturing firm in Cape Town South Africa and would like to register in Brasil to be able to sell our Spinal System. I am not 100% sure if INMETRO is applicable to us as we do not manufacture an electrical product. We are currently certified by SGS against ISO13485, have CE mark and have 510(k) approval in USA.

I saw on one of the posts that SGS is one of the CB's that can do INMETRO certification. We have just completed a surveillance audit last week with SGS, with no problems and are due for the recertification next year. Do you think already having audits done by SGS may speed up the process, or would ANVISA still need to come out here to audit us?

thanks

Re: Anvisa & INMETRO

Hello sandieash and welcome to the Cove!

I am not 100% sure if INMETRO is applicable to us as we do not manufacture an electrical product

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Inmetro certification is not only for medical electrical products. Right now, it´s for condoms, syringe,s needles, infusion bags, and mammary implants.

I saw on one of the posts that SGS is one of the CB's that can do INMETRO certification.

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This might be related to medical electrical certification.

Do you think already having audits done by SGS may speed up the process

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No.

, or would ANVISA still need to come out here to audit us?

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They will if you your device is under the registration process (classes II and IV and some class II).

For more info on all of this please, review the following threads:

- Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

- Medical Device Registration Process in Brazil - Anvisa

Hi Marcelo,

thanks for the reply - it does clarify things. Have a good day