Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!

Hello,
The most straight forward way to address this is to use a regulatory 'proxy' (i.e., Vera Rosas) rather than distributors to be the point of contact with ANVISA. This allows you to more flexibility.

I hope this helps!


------------------------------
Jim Luker RN, MS
Senior Regulatory Consultant
Innolitics
------------------------------

Original Message:
Sent: 15-Oct-2021 11:15
From: Anonymous Member
Subject: GMP Brazil

This message was posted by a user wishing to remain anonymous

Hello,
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!

Hello,

Completely agree with Jim - better to use a third party organisation to manage the product approvals as then you would have need to just get the GMP certification completed.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Oct-2021 08:51
From: Jim Luker
Subject: GMP Brazil

Hello,
The most straight forward way to address this is to use a regulatory 'proxy' (i.e., Vera Rosas) rather than distributors to be the point of contact with ANVISA. This allows you to more flexibility.

I hope this helps!


------------------------------
Jim Luker RN, MS
Senior Regulatory Consultant
Innolitics

Original Message:
Sent: 15-Oct-2021 11:15
From: Anonymous Member
Subject: GMP Brazil

This message was posted by a user wishing to remain anonymous

Hello,
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!

Thank you!

------------------------------
Arina Lunkina
Mississauga ON
Canada
------------------------------

Original Message:
Sent: 19-Oct-2021 06:12
From: Richard Vincins
Subject: GMP Brazil

Hello,

Completely agree with Jim - better to use a third party organisation to manage the product approvals as then you would have need to just get the GMP certification completed.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 18-Oct-2021 08:51
From: Jim Luker
Subject: GMP Brazil

Hello,
The most straight forward way to address this is to use a regulatory 'proxy' (i.e., Vera Rosas) rather than distributors to be the point of contact with ANVISA. This allows you to more flexibility.

I hope this helps!


------------------------------
Jim Luker RN, MS
Senior Regulatory Consultant
Innolitics

Original Message:
Sent: 15-Oct-2021 11:15
From: Anonymous Member
Subject: GMP Brazil

This message was posted by a user wishing to remain anonymous

Hello,
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!

Thank  you for the suggestion and for the link!

------------------------------
Arina Lunkina
Mississauga ON
Canada
------------------------------

Original Message:
Sent: 18-Oct-2021 08:51
From: Jim Luker
Subject: GMP Brazil

Hello,
The most straight forward way to address this is to use a regulatory 'proxy' (i.e., Vera Rosas) rather than distributors to be the point of contact with ANVISA. This allows you to more flexibility.

I hope this helps!


------------------------------
Jim Luker RN, MS
Senior Regulatory Consultant
Innolitics

Original Message:
Sent: 15-Oct-2021 11:15
From: Anonymous Member
Subject: GMP Brazil

This message was posted by a user wishing to remain anonymous

Hello,
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!

This message was posted by a user wishing to remain anonymous

Hi,
GMP certificate is issued to the MAH by manufacturer.  For example, if there is a TPM providing products to more than one company in Brazil, each local Brazilian company must request one individual GMP certificate.
Additionally, if the country of the manufacturer is part of IMDRF, or if the manufacturer has a MDSAP certificate including Brazilian requirements, the GMP certificate is issued without a dedicated ANVISA´s audit.  If not, ANVISA will schedule a audit (allowed to be virtual after covid-19), and this process can take 2 years or more.
If more than one Brazilian company requests the GMP certificate, ANVISA evaluate and use the same MDSAP certificate or the their audit report to issue the GMP certificate, but only if the audit scope is the same (product risk and classification).
Original Message:
Sent: 15-Oct-2021 11:15
From: Anonymous Member
Subject: GMP Brazil

This message was posted by a user wishing to remain anonymous

Hello,
I would appreciate if someone can shar a knowledge of GMP certification in Brazil. Our situation as follows, a medical device manufacturer (outside of Brazil) has plans to appoint two distributors in Brazil to be responsible for same device line but sold under different brand names. The risk class (IV) of the device requires to obtain GMP from Anvisa first to be able to get a market authorization for the device itself. As known GMP is issued to the manufacturer establishment, however the application and communications with Anvisa is accepted from the appointed local distributor in Brazil. How to deal if there are two responsible distributors? To go through GMP certification twice with each of the distributor (if that is permitted)? Or the manufacturer should get GMP certificate with one the appointed representatives and granted GMP  will be automatically applicable to any other distributors which manufacturer wishes to designate (provide that this is the same device, only a different brand name)?

Thank you in advance!