Brazil (INMETRO) for Medical Electrical and IVD Equipment?

[KB2021]

Hello All,

Is there a list of products that are exempt from INMETRO certification?
Similar to how some countries do not require safety certification marks for products used in an Professional setting vs. Consumer setting?

I have only found if you have an ILAC accredited test report to IEC 60601-1 and apply for ANVISA registration that the INMETRO mark is not required. Is this same path also true for laboratory equipment with a report to IEC 61010-1?

Any references to the applicable rules would be greatly appreciated.

 

[Mikra]

Hello KB,

I am also face on the same situation as you.
If so, I appreciated it if you let me know how it was resolved. And is there anything you can Tip me along the way?

Thank you in advance for your kindness.

 

[kys123]

Hello KB,

I am also face on the same situation as you.
If so, I appreciated it if you let me know how it was resolved. And is there anything you can Tip me along the way?

Thank you in advance for your kindness.

Hello Mikra,

Let me explain the current legislation for a bit of context:

We currently have in force RDC 549/2021 which states that "all equipments under sanitary surveillance must prove that they are safe and effective through a SBAC certification" (SBAC = Brazilian Conformity Assessment System, which frankly is just a fancy way of saying INMETRO evaluation and certification) and "the assessment of their safety and efficacy must be based in the technical standards indicated through IN 49/2019".

IN 49/2019 was revoked by IN 116/2021, which is currently in force and lists the current applicable technical standards in its Annex I.
ABNT NBR is just the Brazilian Association of Technical Standards versions of the IEC standards, so for example, if IEC 60601-2-19 is applicable to your device, it will need an INMETRO certification for this standard and any others that may apply in order to be registered and sold in Brazil.

Regarding medical devices with an ILAC report: yes, it can be used, as long as it spans all the applicable Brazilian standards, but you'll still need a Brazilian notified body to verify it.

I'll include the list of other non-electrical medical devices subject to INMETRO certification (this list and future updates can be seen here) since it may be helpful for other people looking for this kind of information:

• Single-use sterile hypodermic needles
• Sigle-use sterile hypodermic syringes
• Pacifiers
• Transfusion sets (single-use, gravitational and for infusion pumps)
• Mammary implants
• Gloves for surgical and nonsurgical use
• Baby bottles and bottle nipples
• Male condom

If you still need any help I'd be happy to assist.

 

[Mikra]

Thank you for a detailed description.

It is difficult to comply with the 60601 series as our products's intended purpose is for In vitro diagnostic.
As you know, the 60601-1 describes it as "in vitro diagnostic equipment that does not fall within the definition of ME equipment covered by the IEC 61010 series.".
So that's the part I'm confused about.
Does IEC 61010 series equipment not have to go through INMETRO certification despite using electricity?

Best regards,

 

[kys123]

Thank you for a detailed description.

It is difficult to comply with the 60601 series as our products's intended purpose is for In vitro diagnostic.
As you know, the 60601-1 describes it as "in vitro diagnostic equipment that does not fall within the definition of ME equipment covered by the IEC 61010 series.".
So that's the part I'm confused about.
Does IEC 61010 series equipment not have to go through INMETRO certification despite using electricity?

Best regards,

You're welcome.

I can tell you for sure that Anvisa does not require INMETRO certifications for IVD devices, and as far as I am aware none of the current standards in IN 116/2021 apply to them.