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

[Marcelo]

By the way, when a subcontrator must be inspected by ANVISA?
With Single Audit Program, can an only one inspection of a subcontrator be enough for several manufacturers ?

A subcontractor that is the contract manufacturer, you mean? They are usually inspected on the parts of RDC 16 that apply to what they do.

There?s a technical note from ANVISA that explains this - NOTA T?CNICA N? 002/2009/GGTPS/ANVISA (unfortunately the ANVISA website is not working at the moment).

 

[tibon74]

thank you for your answer Marcelo! I have more specific questions.
Question 1: As manufacturer should I request an ANVISA inspection for our raw casting suppliers?
Question 2 : A a component is manufactured by a contrat manufacturer. Then, this part is assamble to a finished product (manufactured in our manufacturing plant) in our manufacturing plant. As manufacturer, should I request an ANVISA inspection for the contrat manufacturer?
many thanks!

 

[Marcelo]

As manufacturer should I request an ANVISA inspection for our raw casting suppliers?

No, suppliers have to be controlled by you.

A a component is manufactured by a contrat manufacturer. Then, this part is assamble to a finished product (manufactured in our manufacturing plant) in our manufacturing plant. As manufacturer, should I request an ANVISA inspection for the contrat manufacturer?

No, only your plant that assemblies the device needs to be inspected. This is the same situation as above, in fact.

 

[tibon74]

Hi Marcelo,

Many thanks! CP 20 indcate "Single paragraph. The grant of approval of the caput of this article may occur upon presentation of a valid audit report, issued by a third party auditing organization, according to specific programs, both recognized by ANVISA.". What does it mean? I understand that it will not be necessary to be insepected by ANVISA if the manufacturer provides an inspection report from recognized authority (FDA, LNE Gmed...) following the MDSAP. Is it exact? Will ANVISA recognize an insepection report from recognized authority dated of 2013 for example ?

 

[Marcelo]

Many thanks! CP 20 indcate "Single paragraph. The grant of approval of the caput of this article may occur upon presentation of a valid audit report, issued by a third party auditing organization, according to specific programs, both recognized by ANVISA.". What does it mean? I understand that it will not be necessary to be insepected by ANVISA if the manufacturer provides an inspection report from recognized authority (FDA, LNE Gmed...) following the MDSAP. Is it exact? Will ANVISA recognize an insepection report from recognized authority dated of 2013 for example ?

Yes, this paragraph was created so ANVISA could accept MDSAP reports (this option don?t exist in regulations at the moment). There don?t seem to be any other "program" in the future as of now, only the MSDAP.

 

[whyjay]

Hi

Is GMP inspection still required for exporting from US to Brazil for a Class1 or Class2 devices as of now?

Regards,
Jagan

 

[Marcelo]

Yes, but only if the device is in the exemption list of Normative Instruction. 02 of May 31, 2011.

 

[whyjay]

Thanks for the reply.

I have checked the translated document on Emergo website.

So based on this list, materials like:

1. Bandages,
2. Surgical dressings
3. Surgical tapes
4. Topical glues (liquid bandages)
5. Hydrogels etc

can go for abbreviated Cadastre process.

Is it a correct assumption?

Jagan

 

[Marcelo]

So based on this list, materials like:

1. Bandages,
2. Surgical dressings
3. Surgical tapes
4. Topical glues (liquid bandages)
5. Hydrogels etc

can go for abbreviated Cadastre process.

It?s correct for 1,2 and 3.

4 and 5 would probably be registro due to IN 02

"1.2.2 Products constituted by gels, creams, pastes, liquids or powder that come into direct contact with the organism"

so they would need the GMP certificate.

 

[whyjay]

Ok. Makes sense for 1,2 & 3.

It is a bit confusing in case of 4 & 5, especially for number 4.

A topical glue or adhesive is like a bandage in use and does not enter the body (ie, not internal use).


Jagan