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Medical Equipment Inmetro Certification Process in Brazil - Part 1

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Paramedic

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#21
Re: Medical Equipment Inmetro Certification Process in Brazil

RDC 350/10 states among other things that some points of the audit can be left out if the manufacturer maintains a QM-system according to RDC59/00 or ISO13485. If I want to register the device after the audit and type test, I need to have the Certificate acc. to RDC 59/00 anyway. Is it then a real advantage to maintain ISO13485 ?
 

Marcelo Antunes

Addicted to standards
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#22
Re: Medical Equipment Inmetro Certification Process in Brazil

RDC 350/10 states among other things that some points of the audit can be left out if the manufacturer maintains a QM-system according to RDC59/00 or ISO13485. If I want to register the device after the audit and type test, I need to have the Certificate acc. to RDC 59/00 anyway. Is it then a real advantage to maintain ISO13485 ?
The point that can be left out is the assessment of the itens of ISO 13485, if you dave a CERTIFIED ISO 13485 system or a CERTIFIED B-GMP.

The advantage is generally related to the timing and the fact that a lot of manufacturers are alread ISO 13485-certified, but not RDC 59 certified.

At the moment it can take more than a year to get a RDC 59 certificate. If you use this route, tyou will need to wait that time to even begin the Inmetro certification process.

This was also done to maintain the "detachment" of both regulators (INmetro and Anvisa). As Inmetro is an IAF and ILAC accreditator, it does have to use international standards in it´s processes. The option to use a RDC 59 certtificate is therefore this, an option to the usual system.
 
E

engmanager

#24
Re: Medical Equipment Inmetro Certification Process in Brazil

Can a company provide its own 60601-1-4 documentation to Inmetro or does it need to be certified by a TUV/UL type agency?

While we followed the standard, we did not complete the checklist. It was not required by UL or TUV at the time of initial certification. Thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#25
Re: Medical Equipment Inmetro Certification Process in Brazil

Can a company provide its own 60601-1-4 documentation to Inmetro or does it need to be certified by a TUV/UL type agency?

While we followed the standard, we did not complete the checklist. It was not required by UL or TUV at the time of initial certification. Thanks
Technicaly, you would need to have a test report for IEC 60601-1-4. However, some certification bodies (they conduct the process, not Inmetro) are accepting the information provided by the manufacturers, and they analyse this documentation (instead of a the house).
 
R

recruit

#26
Re: Medical Equipment Inmetro Certification Process in Brazil

I would say that the MDD guidance (NB-MED/2.5.2) would be a better guidance to use. At least that´s what i´m mainly using to draft the brazilian guidance document.
Good news. But the MDD guidance is relevant to CE approval which is significant from INMETRO certificate. I wonder how you will establish the guidance. When will the new guidance be released?
 
E

engmanager

#27
Re: Medical Equipment Inmetro Certification Process in Brazil

Our products are currently registered by Anvisa and sold in Brazil (without Inmetro certification). We are now going through re-registration with Anvisa on the same products. Is there a way we could justify not getting Inmetro certification on the current products?

We are trying use UL Brazil for the Inmetro cert and finding it difficult at best.

If no way out of getting Inmetro, any suggestions for another agency besides UL?

We went the UL route due to having UL approval in the states.

Thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#28
Re: Medical Equipment Inmetro Certification Process in Brazil

Is there a way we could justify not getting Inmetro certification on the current products?
No, if your product is a medical electrical equipment as defined in IEC 60601-1, certification is mandatory.

If no way out of getting Inmetro, any suggestions for another agency besides UL?
There´s a lot of certifications bodies operating in Brazil for med, for example TUV, NCC, SGS...
 
R

recruit

#29
Re: Medical Equipment Inmetro Certification Process in Brazil

Hi Marcelo.
Our certified body require update these old certificates according to Portaria 350 as follows:
1. audit of the importer
2. audit the manufacturer accordance with ISO 13485
3. reissue of the certificates.

For Item 2, the body needs a copy of the last factory inspection REPORT of
ISO 13485 rather than ISO 13485 certificate. Do you think it is reasonable? In fact, our facility got B-GMP last year. Is it acceptable that provide publication OJ of B-GMP from ANVISA?

Another question, after updating these certificates, will expire date of certificate automatically extend another five years?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#30
Re: Medical Equipment Inmetro Certification Process in Brazil

Hello Recruit

Yes, at the moment there´s 3 things you can do to fulfill the quality system requirements of Portaria 350.

1 - be audited to some requirements of ISO 13485 as detailed in Annex B
2 - have an valid and traceable ISO 13485 certificate.
3 - have a valid B-GMP certificate

Please note that "a copy of the last factory inspection REPORT of
ISO 13485 rather than ISO 13485 certificate" is not an option..they need to audit, or use a valid and traceable certificate.

You need the B=GMP certificatr per se but i would not this it wold be a problem using the publication of the GMP from the OJ (althoug this is not clear on the regulation).

And yes, you have another 5 year valid certificate, but please be aware that the maintenance process would be more stringtnet following Portaria 350.
 
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