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anvisa, brazil, cadastre process (simplified registration), mdr (medical device regulations), medical device company or industry, medical devices (general), registration to a standard
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  #41  
Old 10th December 2009, 08:44 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
In Reply to Parent Post by mmantunes View Post

No, as i said before, devices under RDC 24 (cadastre) are exept from the need to send the certificate in the registration petition.

This applies (RDC 25) to class II and IV devices, IVD devices of class II, III and IIIA and devices under IN 13 (the exceptions of RDC 24).
Halllo Marcelo,
I have just studied IN13/09. In my opinion, the exeptions of RDC24 are listed in IN07/09. The scope of IN13/09 is the documentation which has to be submitted for the registration.

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  #42  
Old 10th December 2009, 08:48 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Can anyonme tell me how subcontractors will be audited, please ? Does ANVISA perform the audit of the sucontractors by reviewing the audit reports of the Legal Manufacturer ?
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  #43  
Old 10th December 2009, 08:51 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
Halllo Marcelo,
I have just studied IN13/09. In my opinion, the exeptions of RDC24 are listed in IN07/09. The scope of IN13/09 is the documentation which has to be submitted for the registration.
Yes, the type of products that are exempt are "described" in IN 07, but what i tried to say is that IN 13 generally aplies to the exemptions of RDC 24, not that RDC 24 describes what is exempt.

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  #44  
Old 10th December 2009, 09:07 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
Can anyonme tell me how subcontractors will be audited, please ? Does ANVISA perform the audit of the sucontractors by reviewing the audit reports of the Legal Manufacturer ?
From what Anvisa is declaring, depending on how critical, to the manufacturing process, is the work perform by the third party Anvisa will audit this third party (the main concern of Anvisa is to audit the critical parts, not an "office" with a lot of papers).

Incidently, yesterday the head of the medical device pre-market division of Anvisa told that they have done 40 foreign inspections and will do more 30 this year, and that Anvisa expects to perform 400 next year. Some more detailed information will be available after i talk with people that was audited (because this is a new process and some of the details aren´t yet well defined).

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  #45  
Old 10th December 2009, 09:09 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
Could anyone point me in the right direction with regard to medical device regulations for registering a class II medical device.
RDC 185 is the general registry reg, but we have right now RDC 24 and IN 13 (as mentiones in the other replies for this thread). Depending on you product, you might need a cadastre (RDC 24) or a registry (IN 13).

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  #46  
Old 10th December 2009, 10:01 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
In Reply to Parent Post by mmantunes View Post

From what Anvisa is declaring, depending on how critical, to the manufacturing process, is the work perform by the third party Anvisa will audit this third party (the main concern of Anvisa is to audit the critical parts, not an "office" with a lot of papers).

Incidently, yesterday the head of the medical device pre-market division of Anvisa told that they have done 40 foreign inspections and will do more 30 this year, and that Anvisa expects to perform 400 next year. Some more detailed information will be available after i talk with people that was audited (because this is a new process and some of the details aren´t yet well defined).
But how will ANVISA do this if we have for example 50 (or more) subcontractors ? For us it would become cost- and time-expensive and for ANVISA time-expensive.

Another question that I have is: Will the audit be concerned on products/product groups and the certificate issued accordingly ? For example: If I want to get a GMP-Certificate for a product range from product groups A to G - do I have to be audited for EACH product group, or can a representative product (for example C) be audited and the other product groups are also covered ?
  #47  
Old 10th December 2009, 10:07 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Quote:
But how will ANVISA do this if we have for example 50 (or more) subcontractors ? For us it would become cost- and time-expensive and for ANVISA time-expensive.
They will have to decide what to do on each case. As Anvisa will only have the tax fee to pay for the inpections, they will have to compromise on something.

Please keep in mind that there will be a lot of impossible situations in this process, but what is clear is that Anvisa will do something. The amin problem here is that the level of impredictability will only get worse.

Quote:
Another question that I have is: Will the audit be concerned on products/product groups and the certificate issued accordingly ? For example: If I want to get a GMP-Certificate for a product range from product groups A to G - do I have to be audited for EACH product group, or can a representative product (for example C) be audited and the other product groups are also covered ?
These are two questions. these kind of "product ranges' are usually registered as a family, if that´s what you mean.

In the case of inspections, again, the point is the manufacturing process. ig the manufacturing process is for all products in the range, then you will only audit this.

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  #48  
Old 10th December 2009, 10:22 AM
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Re: Medical Device Registration Process in Brazil - Anvisa

Sorry, I am not sure if I understood correctly. For example: I have a surgical laser system, endoscopic equipment, instruments etc.
If only for example the endoscopic equipment is audited: will this be sufficient for all the other kinds of products (laser, instruments,....) ?
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