INMETRO process of Hypodermic Needle in Brazil

[Jenny Baek]

Hello everyone

I need help from a Forums member regarding the INMETRO certification in Brazil.

Our company are preparing for a Brazil medical device registraion of a Class 3 product.

Our products are inserted into the human body and do not require INMETRO certification, but Hypodermic Needle, which is included as an accessory which is necessary the INMETRO certificate and we are preparing for the INMETRO test.
(We final pack the needle in the blister with the product.)

We know that the INMETRO certificate requires a manufacturer audit.
Q1) In this case, Is it necessary audit for all manufacturer? It means real manufacturer site (Needle) and final manufacturer site (our product inculding Needle).

In case of Needle manufacter, They already get the INMETRO certificate but this is certified by a non-us company. We know that this certificate can not be used because it is not a certificate issued in our name or in the name of our BRH.
Q2) To register ANVISA, who the certificate issue? BRH or our company?

Q3) I am refer to INMETRO guideline of needle (Portaria n.º 501, de 29 de dezembro de 2011). It issued in 2011. Is it latest guideline?

I look forward Forums member's answer who know INMETRO process.

Thank you

 

[Marcelo]

We know that the INMETRO certificate requires a manufacturer audit.
Q1) In this case, Is it necessary audit for all manufacturer? It means real manufacturer site (Needle) and final manufacturer site (our product inculding Needle).

Comment Marcelo: Probably both, but this need tone clarified with ANVISA (for registration, because then you would need both GMP Certificates) and the OCP (for INMETRO).

In case of Needle manufacter, They already get the INMETRO certificate but this is certified by a non-us company. We know that this certificate can not be used because it is not a certificate issued in our name or in the name of our BRH.

Comment Marcelo: As you use their device to create a "system" to sell, you can use their certificate. For the registration, you will need verification and validation activities that show that the use of these devices together is safe.

Q2) To register ANVISA, who the certificate issue? BRH or our company?

Comment Marcelo: As I mentioned previously, in the particular case you do not need the INMETRO certificate in principle.

Q3) I am refer to INMETRO guideline of needle (Portaria n.º 501, de 29 de dezembro de 2011). It issued in 2011. Is it latest guideline?

Comment Marcelo: It is not a guideline (which are not mandatory), it's regulations (which are mandatory). But yes. it is still Portaria n.º 501.

 

[Jenny Baek]

We know that the INMETRO certificate requires a manufacturer audit.
Q1) In this case, Is it necessary audit for all manufacturer? It means real manufacturer site (Needle) and final manufacturer site (our product inculding Needle)...

I really thank you for your reply