Implementation of GMP - Technical files for ANVISA Registration

O

orthoimplants

Dear All,

I apologize if I am posting my request not in the right thread as I am quite new here and need to find out how the things are going here.

I am working in a small sized company located in Switzerland. We are selling orthopaedic implants such a nailing, plating and spine systems ( class IIa and IIb according to CE requirements). So far we were PLM and now we are going to manufacture own products with a partner acting as subcontractor.

We have already appointed a distributor company in Brazil. So we need to get registrated by ANVISA.

We are certified according to ISO 13485 and have CE approval.

We are looking for someone who is capable to assist & lead us with following:
a) implementation of GMP procedures
b) creating technical files for class IIa and IIb products

Who can offer us such a service ?

I would appreciate your answers.

Thanks in advance
 
M

Marcelo

Inactive Registered Visitor
Hello and welcome to the Cove!

You are in the right thread.

You mentioned that you have already appointed a distributor company, is it a medical device company or one of those BHR services? If the latter, they usually can offer services for implementation of GMP procedures and technical file creation. If not, even your distributor company could help you with that, maybe.

Regarding the devices, as you have classes IIa and IIb (which usually means class II and III in Brazil) and understanding that your IIa devices are not in the exemption list of IN 02, you will have two pathways, the cadaster one (which does not need the GMP certificate) for classe IIa, and the registro one (which requires the GMP certificate) for class IIb. As the GMP certificate is taking years to get, you will need to focus on the class IIa devices.

As always, due to all those complications, my suggestion would be that, whoever you use, to create a regulatory strategy plan for your devices to better deal with those uncertainties in the Brazilian process (which mint get a little more complex this year as ANVISA is going to revise RDC no 59/08 and IN no 01/09 and mayyyyybe begin the INMETRO certification process for orthopedic implants that they have been wanting for a long time - although I doubt about this last one in the near future :)).
 
O

orthoimplants

Hi Marcelo,

thanks a lot for your prompt reply.

We appointed a distributor company and they will be the BRH. We are aware that having the distributor as BRH might result in disadvantages for us. Unfortunately they are not in the position to provide us support in implementation of GMP.

You are right it will takes quite long until getting Anvisa approval. In the meantime we would like to take the time for the implementation of GMP and technical files.

You mention Anvisa may be begin the INMETRO certification process. Does this mean that the registration procedure is becoming even more complicated and difficult ?


We would prefer a Brazilian consulting company than a German or Swiss one. We believe that Brazilian consulting companies are more common and used to the regular procedures of Anvisa.

I noticed from your profile you are working for SQR Consulting. Do you offer such a service to lead companies for Anivsa approval ?
or can you recommend a consulting company ?

In case you would not like to post any company names and I can provide you my email address you can mail to.

Best
Mirko
 
M

Marcelo

Inactive Registered Visitor
Hello Mirko

You are right it will takes quite long until getting Anvisa approval. In the meantime we would like to take the time for the implementation of GMP and technical files.
Click to expand...

In fact, there are two different times. It takes time to get the registration after submission (one year or more nowadays for materials such as yours) and it also takes a lot of time (more than 3 years now) to get the GMP certificate, if you need it. In your case, you would only need the GMP certificate for your class IIb devices (which are under the "registro" route), not your class IIa (which are under the "cadastro" route) - those you can submit quickly. For more general information on those processes, please take a look at the following threads:

Medical Equipment Inmetro Certification Process in Brazil - Part 1

Medical Device Registration Process in Brazil - Anvisa (Part 2)

Medical Device Registration Process in Brazil - Anvisa (Part 3)

You mention Anvisa may be begin the INMETRO certification process. Does this mean that the registration procedure is becoming even more complicated and difficult ?
Click to expand...

Yes, ANVISA has for some time commenting that they will require, in the future, the INMETRO certificate for some implants. And yes, the registration will be a lot more complicated and difficult. But I don?t think this will be required this year, in my opinion it will still take some time because there?s a need to establish the capacity in Brazil for the certification, meaning, accredit certification bodies and test houses (but ANVISA did work with some labs in the past year to develop the capacity for testing, because they are still pursuing this option).


I noticed from your profile you are working for SQR Consulting. Do you offer such a service to lead companies for Anivsa approval ?
or can you recommend a consulting company ?

In case you would not like to post any company names and I can provide you my email address you can mail to.
Click to expand...

Yes, I do offer these services, I will PM you with more information.
 
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