Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

Roland chung

Trusted Information Resource
#1
Hello folks,

In the Brazil, as I know, there are certification process (INMETRO) and registration process (ANVISA) set for the medical device approval.

But I could not understand the INMETRO and ANVISA very well. I would like to raise some questions. Any comments are highly appreciated.

1) INMETRO is not only for medical device, it is also suitable for ordinary electrical products. Am I right?

2) ORDINANCE No. 350/2010 states that INMETRO is voluntary certification, except for products for which the Regulation Agency, Anvisa,
requires compulsory certification by means of the IN/Anvisa in effect. I want to know that where can I get the regulation of ANVISA? I could not find something in the www.anvisa.gov.br/eng/index.htm

3) I am wondering if all of the Medical Electrical Equipments are under the mandatory certification. I was told that if the standards are mandatory then the certification is compulsory. It seems that ABNT NBR IEC 60601 series are mandatory.

4) Can I skip the INMETRO certification and apply for the ANVISA registration directly? If there is an official document to explain this issue?

5) I was also told, the ANVISA could only be handled by UL Brazil. I am totally confused. As I know, certification bodies should be involved in the INMETRO process. But ANVISA can be done by Registration Offices and/or Legal Representers or Importers.

Thanks and regards,
Roland
 
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Marcelo

Inactive Registered Visitor
#2
1) INMETRO is not only for medical device, it is also suitable for ordinary electrical products. Am I right?
INMETRO is government agency which deals with metrology, quality and technology. From the standpoint of the government, any equipment which does not have a regulatory body could be regulated by Inmetro. Even the ones which have can use Inmetro process if they want to. Also, Inmetro is the Brazilian NMI, the Brazilian accreditator body, and a lot of other things. For example, all "formal" certification process, of everything in Brazil, are under Inmetro.

2) ORDINANCE No. 350/2010 states that INMETRO is voluntary certification, except for products for which the Regulation Agency, Anvisa,
requires compulsory certification by means of the IN/Anvisa in effect. I want to know that where can I get the regulation of ANVISA? I could not find something in the www.anvisa.gov.br/eng/index.htm
Nothing in English for medical devices. The Normative Instruction (IN) now is IN 03/2011 - http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/int0003_21_06_2011.html

Just to clarify things - to register/cadastre medical devices in Brazil, you have to go thru the regulator - Anvisa - registration/cadastre process. In the case of medical equipment, RDC 27/2011 is applicable, which requires compulsory certification following the Inmetro certification process (Ordinance 350). IN 03/201 details standards, and the devices towhich the standards are applicable needs compulsory certification for ANVISA registration/cadastre.

3) I am wondering if all of the Medical Electrical Equipments are under the mandatory certification. I was told that if the standards are mandatory then the certification is compulsory. It seems that ABNT NBR IEC 60601 series are mandatory.
Historically, medical electrical equipment have been the only equipment with compulsory certification. Since two regulations ago, ALL medical electrical equipment required compulsory certification (at least to the general standard) and the, RDC 27 expanded it´s scope to all equipment under Anvisa regulations. IN details which equipment needs compulsory certification. At the moment, there´s only standards for medical electrical equipment, meaning only MEE requires compulsory certification. When Anvisa puts other standards in IN, other equipment will also require compulsory certification (example - IEC 61010 will in the future be included in the IN, so compulsory certification wil be required for all laboratory medical equipment).

4) Can I skip the INMETRO certification and apply for the ANVISA registration directly? If there is an official document to explain this issue?
You can, but Anvisa will simply deny you registration/cadastre because you did not include the required documentation (in the case, the Inmetro certificate). In the past, you could begin the registration/cadastre process without finishing the Inmetro process, however since 2004 (when a RDC that defines that Anvisa can deny any petition automatically if the required documentation is not included was published) you cannot do this anymore.

No, there´s no "official" document to explain this, only this RDC that i mentioned (I don´t remember it´s number now).

5) I was also told, the ANVISA could only be handled by UL Brazil. I am totally confused. As I know, certification bodies should be involved in the INMETRO process. But ANVISA can be done by Registration Offices and/or Legal Representers or Importers.
Don´t know what you heard, but take care.

The Inmetro certification process is handled by CBs accredited by Inmetro to handle this process. UL is among them, but there are 12 others (TUV, NCC, BVQI, SGS, etc).

Besides the need for the certificate, there´s no other link between Anvisa and Inmetro processes. All Anvisa processes are handled only by Anvisa (example - if you need a B-GMP certificate - a requirement for device registration, not cadastre - you will need to ask Anvisa to perform an inspection, and after the inspection Anvisa will give you a certificate. Only Anvisa can do that.

For more info, take a look at this thread: Medical Device Registration Process in Brazil - Anvisa
 
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Roland chung

Trusted Information Resource
#3
Wow, well said and thank you. Unfortunately, as a foreigner, I can not read Portuguese documents. I am also surprise, as a big country, Brazilian government agency does not release English version documents.
 

Marcelo

Inactive Registered Visitor
#4
Hello Tomas, and welcome to the Cove!

This is an experience sharing forum, if you have articles with might help the other Covers and you can share them, why not share them in the forum so other Covers can benefit?
 
R

Reinheitsgebot

#5
Hi Marcelo,

I would be very grateful for your advice on a question to do with the scope of the ANVISA GMP audit of a company's manufacturing facilities.

Is there anything of a product-specific nature in the audit activities and certification award? - for example if company X makes ten different Class III/IV medical device product lines and is currently wishing to register two of these in Brazil, will ANVISA focus on the production processes related only to those two products when performing the GMP audit? - or will they, by default, tend to look at processes relevant to all ten product lines?

The reason I ask is supposing subsequently company X decides to register extra product lines in addition to the two previously registered, I am currently assuming that the GMP certifcate awarded by ANVISA would cover these extra products (in fact will cover all ten product lines) so there would be no need for any additional ANVISA GMP activities - would my assumption be correct?

On that basis, I presume it is advisable in all submission documents for the ANVISA GMP process to make it clear that the scope of the company's activities includes ten product lines, even if the current registration activity is only concerned with two of these.

I understand of course that the INMETRO technical certification processes are, in contrast, product-specific by nature, so one may well require ten separate INMETRO certifications if one wished to register all ten product lines.

Many thanks for any thoughts on the above,

Best Regards -

R'gbot
 

Marcelo

Inactive Registered Visitor
#6
The reason I ask is supposing subsequently company X decides to register extra product lines in addition to the two previously registered, I am currently assuming that the GMP certifcate awarded by ANVISA would cover these extra products (in fact will cover all ten product lines) so there would be no need for any additional ANVISA GMP activities - would my assumption be correct?
Anvisa "is" worried about the production process of the device/s which will be registered.

If the ten product lines are the same (the idea here is the same production processes) , when you go register the extra you can mention that to Anvisa and they will probably not require another inspection - I just mention probably because things are constantly changing at Anvisa and their interpretation right now seems to be that (I was discussing this subject this week and we have more than one case in which Anvisa did exactly what I said).

If you have too distinctive product lines (the best example is if you make implants and IVDs) then Anvisa will require two different certificates.
 
R

Reinheitsgebot

#7
Thank you for your advice Marcelo, I very much appreciate it.

It seems one would have to think carefully how closely the production of different products was related, in order to describe the scope of one's requested ANVISA audit, and to describe this quite precisely in the submission documents.

But I also take your point of course, at different times any given regulatory body may choose to vary their approach from what has been done previously, so one should not assume anything without first trying to gauge what the current thinking is.

Best Regards,

R'gbot
 
Last edited by a moderator:
H

HammyH

#8
Hi,

I am a new member and have a question concerning ANVISA Classification and INMETRO certification. I have been given contradictory advice regarding the classification of pregnancy tests. The tests are digital - i.e. they have a digital presentation of the result. I have been advised that these are Class IIIa IVDs and no INMETRO certification is required. On the other hand, I have also been advised that these are electro-medical (Rule 10, Class II) Medical Devices and INMETRO certification is required. We claim compliance with IEC 61010, for lab equipment, not 60101, and are hoping that we do not need to have the devices tested to 60101 for INMETRO certification.

I would really value you opinion on this situation.

Many thanks, HammyH
 

Marcelo

Inactive Registered Visitor
#9
Hi,

I am a new member and have a question concerning ANVISA Classification and INMETRO certification. I have been given contradictory advice regarding the classification of pregnancy tests. The tests are digital - i.e. they have a digital presentation of the result. I have been advised that these are Class IIIa IVDs and no INMETRO certification is required. On the other hand, I have also been advised that these are electro-medical (Rule 10, Class II) Medical Devices and INMETRO certification is required. We claim compliance with IEC 61010, for lab equipment, not 60101, and are hoping that we do not need to have the devices tested to 60101 for INMETRO certification.

I would really value you opinion on this situation.

Many thanks, HammyH
Hello HammyH and welcome to the Cove!

If they are MEE - Medical electrical equipment as defined by IEC 60601 - then Inmetro certification is required (please note that this is totally separate from the Anvisa classification scheme)

If they are any other kind ofelectrical medical device, then at the moment Inmetro certificatio is not required.

IN your case, as you already mentioned, they are possible considered lab equipment under 61010. IEC 61010 certification is not required at the moment, but will in the near future (we are finishing the internalization process of the third edition of the standard and Anvisa will begin requiring certification to IEC 61010 afterwards).

Also, some certification bodies do not know this (or they know, which is worse) and might be trying fo force you to do something which you don't need to.
 
H

HammyH

#10
Hi Marcelo,

Thanks for the welcome and for the information you have provided. We consider that the devices are not medical electrical equipment as defined by IEC 60601 and therefore INMETRO certification will not be required.

You say that IEC 61010 certification will be required soon. Do you know when this might be? We are currently in the process of registering products for sale in Brazil. We submitted GMP inspection requests to ANVISA in July 2011, so it is possible that the GMP inspections will take place towards the end of 2012. We would then like to make our regulatory submissions. Should we be ensuring that we have valid IEC 61010 test reports for the products now in case certification is required when we make our regulatory submissions to ANVISA, hopefully early in 2013?

Many thanks,
HammyH
 
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