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Marcelo Antunes

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#1
Some people asked me - maybe years ago :) - to write something about the medical device registration process regulated by Anvisa in Brazil. Well, i´ve made a flowchart (based on a guidance document Anvisa developed) for a potential client and thought it might help others here. It´s a generic flowchart detailing the generic documentation that is needed to obtain the register. Cheers.
 

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kristigusman

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Re: Medical device registration process in Brazil - Anvisa

Some people asked me - maybe years ago :) - to write something about the medical device registration process regulated by Anvisa in Brazil. Well, i´ve made a flowchart (based on a guidance document Anvisa developed) for a potential client and thought it might help others here. It´s a generic flowchart detailing the generic documentation that is needed to obtain the register. Cheers.
Where can I find that guidance document developed by ANVISA you mentioned?
 

Marcelo Antunes

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Re: Medical device registration process in Brazil - Anvisa

Where can I find that guidance document developed by ANVISA you mentioned?
Great timing on the question. The document i mentioned was made last year, but has been postponed ever since. It´s been officially published last week, but has had a lot of modifications.

This is because there´s been recently some major modifications in the medical device registration processes.

The manual can be accessed on the following link: Manual for the regulatization of medical equipment at Anvisa - Brazil (in portuguese)

Not that the manual is for medical "equipment', usually related to medical electrical equipment, and not really for the whole lot of medical devices..but as this is the only one of it´s kind, i usuallu use it to "guess" some interpretations on other kinds of devices too.
 

gramaley

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#5
Re: Medical device registration process in Brazil - Anvisa

I'm told the GMP requirements are going to be strictly enforced as of May 2010 and that any class 2 devices that are on the market and have not been part of the B-GMP inspection process will be illegal. I'm told that some bigger medical device companies are so concerned that they are asking their certification bodies to talk to ANVISA about accepting similar type surveillance, CMDCAS certificates and to consider IAF MDCAS accredited ISO 13485 certificates (program still being developed) INMETRO is an IAF member.

My question is, how are they determining the risk class of a medical device? are they using GHTF risk rules? Are they borrowing from the US FDA product classifications?

Thanks for the chart and the link to the manual, unfortunately for us "foreigners" we don't speak/read portuguese, so the manual is mostly useless.
 

Marcelo Antunes

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#6
Re: Medical device registration process in Brazil - Anvisa

The Brazilian classification rules as the same as the medical device diretive classification rules (not the revised ones). RDC 185, which is the general medical device legislation, is almost a copy of the MDD.

This is the basic problem of the brazilian regulation...it´s based on the MDD, but have a GMP derived from the FDA.

The discussion on Anvisa accepting ISO 13485 certification is an old one. In general, Anvisa´s refusal on accepting ISO 13485 is dus to the fact that ISo 13485 is "less stringent" than a GMP. This is true, but they miss the point that both are ways to demonstrate the "quality system" aspect of medical device regulations.

You´re right, recently there´s been major modifications on brazilian the medical device requirements. RDC 25 (whose implementation period will be until May 2010) requires a strictly enforced B-GMP inspection scheme, even to foreign manufacturers. It applies to product of Class III and IV (IIb and III of MDD), II, III and IIIa IVDs, and the exceptions of RDC 24 (see below, these products are the ones to which the future RDC 26 will apply).

RDC 24 is for Class I and II devices...devices under RDC 24 do not require a registration anymore..they requires a "cadastre" (but there´s a list of exceptions, for example, medical electrical equipment). Equipment under RDC 24 does not need a B-GMP certificate, but they still need to comply to the B-GMP

RDC 26 (which is in public consultation right now) will apply to the exception list of RDC 24 and will also require a strictly enforced B-GMP inspection scheme, even to foreign manufacturers. These devices will still need registration.

Abimed (which is the brazilian medical devices importer and distributor association) has been for a time trying to convince Anvisa on the acceptance of foreign inspections of ISO 13485 (this would be in place of the GMP) to no avail.

The option of using an INMETRO_IAF scheme is a new possibility we are discussing, but it applies only to the certification of medical electrical equipment, not to other medical devices (incidentally, i´m a member of Abimed and i usually gives them technical help on the medical electrical equipment certification process, of which i have a lot of experience).
 

gramaley

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#7
Re: Medical device registration process in Brazil - Anvisa

Wow, thanks. This is very helpful. I'm working on the IAF MDCAS accredited ISO 13485 certificate. Inmetro appears to be operating as an accreditation body for certification of products for ANVISA, but they also provide accreditation activities for QMS under the ISO 9001 scheme, which we all know is unnacceptable for our sector. Nonetheless, the ISO 13485 QMS accreditation process for IAF MDCAS utilizes ISO 17021, just as INMETRO should be familiar with in accreditation activities for ISO 9001. The transition for them to provided accredited certificates under IAF MDCAS for ISO 13485 is not beyond their capability.

Your organization may want to revisit this idea, since IAF MDCAS would allow ANVISA to use INMETRO's QMS accrediation services in the future to create a more competent (and transparent ISO 13485 surveillance program) one that will ultimately replace failed national approaches to using national GMP inspections. I say it will fail, because people demand healthcare from the plethora of devices sold everywhere outside their borders. There are 90,000 medical device circulating from all parts of the world. To filter them through a GMP is impossible. The US FDA has tried this and failed terribly. The average foreign manufacture making class 2 devices gets inspected only once in 27 years. There simply are not enough inspectors or money to pay for the demand for medical devices. If the US has failed this badly, how can any country succeed.

FYI the FDA is looking to transition to ISO 13485 over the next 8 years. They're just not sure how. I'm talking with them though and they are at least listening. I hope ANVISA will too.
 
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kakadu

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#8
Re: Medical device registration process in Brazil - Anvisa

Marcelo, I notice in your registration flowchart that only some medical electrical equipment require the INMETRO mark. I have also read elsewhere that INMETRO certification of electro-medical devices is restricted to a list of devices published by ANVISA as "IN-8". Do you know of a copy of this list in English or can you outline the inlcuded devices? Our company makes MDD class IIa & IIb ventilation and related devices. Some of our devices receive UL/CSA certification but others from EU do not.
 

Marcelo Antunes

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#9
Re: Medical Device Registration Process in Brazil - Anvisa

The list of particular standards (until now, only equipment which have particular standards and brazilian laboratories accreditated on them are under compulsory certification - the list on IN 08 reflects the Brazilian lab accreditation) is on IN 08, which can be seen in the following link: http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=27015&word (the link is for RDC 32, which is the regulation regarding certification..you need to click on "Instrução Normativa nº 8, de 29 de maio de 2007" to go th IN and the list).
The list is of brazilian ABNT NBR standards, but they´re mainly equivalent to IEC second edition particulars.



BUTTTTTTTTTTTTT...some more news i forgot to tell before...... there will be a radical change in the brazilian medical electrical equipment certification scheme... Anvisa will require compulsory certification to ALL medical electrical equipment under ABNT NBR IEC 60601-1 (the general standards, equivalente to the second edition IEC), not only the ones with particulars.

This has not yet been done, but Anvisa has already stated that (meaning there´s a 99.999999 % chance of happening), and, as this will be done via a revision of IN 08, it won´t even need a public consultation (although Anvisa will give a 6-month "transition" time, due to the need of capacity updating by the labs.

This will in my opinion cause a whole change on the field (a lot of manufacturers has never done certification due to not having compulsory particular equipment), but in fact is an old idea (for example, it was not implemented before due to shortage of laboratories to fulfill the demand).
 

gramaley

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#10
Re: Medical Device Registration Process in Brazil - Anvisa

Since this is such a hot topic right now for medical device industry, I tried to translate these documents into English using the Google translator. I had to cycle the translation back and forth a few times on the longer documents, like the Guidance to get it to fully translate. (I attached the Guidance in English).

One point I'd like to make about INMETRO is that they are "signatory" to a multilateral recognition agreement among other Accreditation Bodies that provide accreditation of product testing labs. Indeed, the language in the ANVISA reg is much like the OSHA 29 CFR 1910 reg that states "Electrical Equipment must be approved" Perhaps this is Brazil's reciprocation.

Anyway, the way I understand the ILAC MRA is that INMETRO should recognize test reports issued by other labs that have been accredited by other ILAC MRA Signatories outside of Brazil. You would have to find out whether your lab was accreditated to ISO 17025 by another ILAC member that participated with INMETRO in signing the agreement to recognize each others accreditation activities. You may have to contact the lab and have them send over their "Accrediation Certificate" to ISO 17025. It will show you who the accreditation body was. Some labs in the US are accredited by SCC (Canada) as well as a US accreditation body (A2LA or ACLASS).

Although UL and other labs may offer "INMETRO certification" (at additional cost) I've found that other countries will accept a UL report (as is) if the testing lab (e.g. name and laboratory's street address) was accredited by an ILAC member MRA signatory (SCC, ACLASS, A2LA are all signatories - see attachment). INMETRO is a signatory with as many as 40 other international accreditation bodies that perform accreditation of testing labs. Since some important countries are turning to IEC 60601-1 for registering medical devices, this is something worth exploring.

The objective of "tested once, accepted everywhere" concept may help with Brazil, China, Israel and many other countries that are leaning towards use of the IEC 60601-1 standards for product approval. You may also want to check with IECEE.org for labs participating under a very similar "Certification Body "CB scheme". Although the CB Scheme this is a "Peer review" scheme occuring relying on assessments by the testing labs themselves, they are cooperating with the IAF and ILAC to make it more credible than ever.

If you already have a UL/CSA reports for your medical device, try and use the ILAC and IECEE schemes to build confidence in your existing test reports with foreign regulators who might otherwise insist on retesting to the same IEC 60601-1 standard. This can save many thousands of dollars.

I translated some of the other documents Marcello has so graciously pointed us to. I didn't want to overload the website, especially since anyone can translate this using google translator.
 

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