Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

[tibon74]

Thank you Marcelo !
Also, the problem is the meaning of "expressive responsibility". If the legal manufacturer renovates the products after the request and under responsibility of registration holder, can we call that expressive responsibility ? How much does it take to have the approval from ANVISA?

On the other hand, is it possible to import and sale in brazil products which previously left the warehouse but never used ?

thanks again !

 

[tibon74]

Could someone help me?

thank you!

 

[Marcelo]

Also, the problem is the meaning of "expressive responsibility". If the legal manufacturer renovates the products after the request and under responsibility of registration holder, can we call that expressive responsibility ? How much does it take to have the approval from ANVISA?

There?s no defined meaning of this "express responsibility", but ANVISA an understanding that this means that the Brazilian registration holder has to perform the refurbishment. This is nut, and ANVISA is trying to change this regulation to correct the problem (please see a technical note (NOTA T?CNICA N? 05/2012/GQUIP/GGTPS/ANVISA - Esclarecer sobre a CP no 34/2011, que trata do recondicionamento de equipamentos usados destinados ao mercado brasileiro)

On the other hand, is it possible to import and sale in brazil products which previously left the warehouse but never used ?

There?s nothing clear on this aspect on the regulation, but in principle if it left the warehouse (and manufacturer?s control) it?s considered used, even if not used in practice.

 

[tibon74]

Thank you! is there another regulation than RDC25/2001 on the definition of used products (mainly for products not used in practice)?

In the Nota technica it is mentioned: "Ressalta-se que, no Brasil, a proibi??o da comercializa??o de equipamentos de interesse em sa?de usados, bem como, a obrigatoriedade de realiza??o do recondicionamento pelo detentor do registro/cadastro na Anvisa, ou por terceiro sob sua responsabilidade, j? existem e est?o em vigor desde 2001, por meio da Resolu??o Anvisa RDC n? 25, de 15 de fevereiro de 2001". By "por terceiro sob sua responsabilidade" I understand that a foreign legal manufacturer can be a third party. Correct ?

With this requirements "Fica proibida a importa??o de equipamentos m?dicos usados para serem comercializados, doados ou recondicionados no pa?s – o recondicionamento ser? permitido apenas para os equipamentos de produ??o nacional ou os que tenham ingressado no pa?s na condi??o de novo. Tal medida visa evitar que o Brasil se torne dep?sito de lixo tecnol?gico de outros pa?ses" it will be not possible to import Refurbished products if they were not be previously used in Brazil ?

A last question. How much time does it take to have the approval (authorization) from ANVISA to import Refurbished products?
thank you!

 

[tibon74]

Hello!

Could anyone help me?
on the other hand, does anyone know when CP34/2011 will be published ?

thank you !

 

[karen12]

Dear all,

Our company decided not to renew ANVISA of the device that was registered in 2010. At that time, GMP was not required so that we didn't receive on-site inspection from ANVISA.

In this case, until when are we able to sell the device into Brazilian market if the expiration date of ANVISA is Nov. 30th, 2014?

For instance, if the expiration date of device ANVISA is Nov. 30th in 2014 and the expiration date of GMP is Dec. 31st in 2014, is the distributor resided in Brail able to import the device from manufacturer until Nov. 30th and distribute the imported device until the GMP of the device expires which is Dec. 31st? Or can the distributor sell the imported device after the GMP expires since the devices were imported legally within the period?

Thank you so much in advance!!!

 

[Geo-Ans]

Hello Marcelo,

A quick question concerning ground bond test for manufacturing for medical equipment destined to Brazil.
Per Annex A of the Inmetro Ordinance 350, 100% manufacturing tests of ground bond and other tests are required in newly produced equipment.
The question is, a medical device marketed worldwide is classified as type B (or grounded equipment relying on a protective earth connection) but in lieu of a protective earth it complies with the limits of under 100uA patient leakage (no MoPP) or under 500uA patient leakage (1 MoPP) as certified by an acredited NRTL, since the medical equipment mentioned above relies in a functional earth construction instead of a protective earth, is there any approach to suffice the 100% manufacturing tests requirement ? or, would the regulator accept a construction brief detailing the compliance approach?.

Bottom line is not even possible to do a manufacturing ground bound test in equipment with no protective earth

Thanks in advance for any help,

Geo-Ans

 

[Marcelo]

A quick question concerning ground bond test for manufacturing for medical equipment destined to Brazil.
Per Annex A of the Inmetro Ordinance 350, 100% manufacturing tests of ground bond and other tests are required in newly produced equipment.
The question is, a medical device marketed worldwide is classified as type B (or grounded equipment relying on a protective earth connection) but in lieu of a protective earth it complies with the limits of under 100uA patient leakage (no MoPP) or under 500uA patient leakage (1 MoPP) as certified by an acredited NRTL, since the medical equipment mentioned above relies in a functional earth construction instead of a protective earth, is there any approach to suffice the 100% manufacturing tests requirement ? or, would the regulator accept a construction brief detailing the compliance approach?.

Bottom line is not even possible to do a manufacturing ground bound test in equipment with no protective earth

Hi

If it does not have protective earthing, earth bonding is not applicable (also, please note that type B is classification of the applied part, not the medical device. In this case, what shows that the device does not use protective earthing is it being type II - which I understand your device must be - not the applied part classification).

 

[yzl1018]

Marcello,
Hello!
Our factory intends to register a product in Brazil. Due to our product belongs to class III, we have to apply a GMP inspection.
However,before GMP inspection, what regulations should we comply with? Could you please show me the requirements, such as labelling, technical file, applicable product standard, adverse incident reporting, recall?
Note: I only know a BGMP regulation (RDC 16/2013).
Thank you in advance!

 

[Marcelo]

Our factory intends to register a product in Brazil. Due to our product belongs to class III, we have to apply a GMP inspection.
However,before GMP inspection, what regulations should we comply with? Could you please show me the requirements, such as labelling, technical file, applicable product standard, adverse incident reporting, recall?
Note: I only know a BGMP regulation (RDC 16/2013).
Thank you in advance!

Well, generally speaking, for a GMP inspection you need to comply with RDC 16/2013.

However, there are several other RDCs applicable to devices, and you may need to include some of them clearly in your quality system.

Two generic ones that are important are the post-market surveillance and field safety actions RDCs (RDC 67/2009 and RDC 23/2012).

For the other ones, it really depends on the device and an analysis of all applicable regulatory requirements from ANVISA and possible other regulators such as INMETRO.