Medical Device Registration Process in Brazil - Anvisa (Part 2)

Dear Marcelo,

We are registering class IV electro-medical devices in Brazil and we are wondering if the programmers need to be registered also or are considered as accessories. From our experience, it depends on the countries. Sometimes, it requires a specific same class as the devices registration, sometimes it is considered as accessories.

Does it need a specific registration? only an INMETRO certification? nothing and can be considered as an accessory for the devices?

Programmers are used at the implant to program the devices.

Thanks a lot!

We are registering class IV electro-medical devices in Brazil and we are wondering if the programmers need to be registered also or are considered as accessories. From our experience, it depends on the countries. Sometimes, it requires a specific same class as the devices registration, sometimes it is considered as accessories.

Does it need a specific registration? only an INMETRO certification? nothing and can be considered as an accessory for the devices?

Programmers are used at the implant to program the devices.

Click to expand...

The device is an active implant then?

You don?t need certification for active implantable programmers, but they are considered medical devices and need cadastre/registration.

Anyway, if it?s really an active implantable medical device (under ISO ISO 14708), you don?t need INMETRO certification right now even for the device.

Hi Marcelo,

Thanks for your quick response.

Indeed the device is an active implant. Do you mean that even if it's an electro-medical device, as it's an active implant, we don't need INMETRO certification?

For what i understood, we need to have this certification and it adds 6months to the overall general process. If we could go without it, that would be perfect.

And if i understood you correctly, you say that programmers don't need either INMETRO certification BUT need to registered as medical devices also. Right? Is it the same class as the active implant itself?

Thanks a lot.

Indeed the device is an active implant. Do you mean that even if it's an electro-medical device, as it's an active implant, we don't need INMETRO certification?

Click to expand...

Only if?s an active implant under ISO 14708.

For what i understood, we need to have this certification and it adds 6months to the overall general process. If we could go without it, that would be perfect.

Click to expand...

Well, your Brazil office or registration holder should?ve told you that.

And if i understood you correctly, you say that programmers don't need either INMETRO certification BUT need to registered as medical devices also. Right? Is it the same class as the active implant itself?

Click to expand...

Yes, no certification but needs cadastre/registration. It?s in fact considered an active implant itself, i nthe same rule and class of the active implant.

We haven't started the process yet. It's planned for any time soon. But i agree with you it's something we need to know ASAP. Thanks for your precisions.

Have a nice day!

Hello,

We will be inspected by ANVISA which requested us to fill a form. We have to indicate in this document if our medical devices are " Equipment" or " Materials". What is the difference between "Equipment" and "Materials. What should we to fill? for information we manufacture orthopedic prostheses (implants and instruments. We also manufacture a navigation system (instrument allowing an implantation computer-assisted)
Thank you for your help !
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We will be inspected by ANVISA which requested us to fill a form. We have to indicate in this document if our medical devices are " Equipment" or " Materials". What is the difference between "Equipment" and "Materials. What should we to fill? for information we manufacture orthopedic prostheses (implants and instruments. We also manufacture a navigation system (instrument allowing an implantation computer-assisted)
Thank you for your help !
bye!

Click to expand...

There's no clear definition in the regulations between equipment and materials, which is weird

Generally, equipment are active devices, such as medical electrical equipment, IVDs, etc (although there are some equipment which is not active such as non-powered wheelchairs).

If your implants are not active, they will be materials. Your navigation system is probably a equipment.

Hello !

ok thank you !!

Taieb

Hello everybody!

I would like to know if, during an ANVISA inspection, inspectors could see the technical files (registration files) submitted to ANVISA for the product registrations ?

thank you !!!!

Our company has moved to a new location and asked the auditor about having a inspection on new manufacturing site. He said that yearly maintenance inspection will be conducted and the certification will be updated once the maintenance inspection is complete. Then, is it ok to send our goods to Brazil with our new address or should we use our old address to send goods until we get yearly maintenance inspection?