Are the ISO Standards actually required for health product registration on ANVISA?

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rafaelbpa

#1
Hello!

Me and my coworkers are working on a product that we belive that would help a lot of people if we can make the dream true, but we have some doubts.

We are trying to develop a health product, so it has a lot of rules. Does anyone know if the ISO 11073 standard is required or is just a standard created for those who want to create products which communicate with others products on market?

If we don't want that our product communicate with other device, except our, even so we have to build it based on ISO 11073 standard?


Thanks in advance.
 
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Marcelo

Inactive Registered Visitor
#2
Re: Are the ISO Standards actually required for health product registration on ANVISA

Standards are not "required" in Brazil (or anywhere) unless they are mandatory (for example, under INMETRO certification).

The ISO 11073 series is for device communication, if your device does not communicate, you don?t need to follow it. Even if your device can communicate, you do not need to follow it, but in this case it might create problems when you try to communicate with another device.
 
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rafaelbpa

#3
Re: Are the ISO Standards actually required for health product registration on ANVISA

Marcelo Antunes, thanks for the quick response, but I still have some doubts.

Yes, it's true, 11073 is for device communication, but we are building our own hardware and software. We don't want that our device communicate with other devices. So, in this case, still we have to follow the ISO 11073 standard?

And if we don't follow this standard, can't we obtain INMETRO certification? Is that a problem?


Best regards
 

Marcelo

Inactive Registered Visitor
#4
Re: Are the ISO Standards actually required for health product registration on ANVISA

We don't want that our device communicate with other devices. So, in this case, still we have to follow the ISO 11073 standard?
No.

And if we don't follow this standard, can't we obtain INMETRO certification? Is that a problem?
No, I just used the example of INMETRO certification, this standard is not used in any INMETRO certification scheme.
 
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rafaelbpa

#5
Re: Are the ISO Standards actually required for health product registration on ANVISA

Oh thanks for clarify!

You helped a lot. Thanks!
 
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