Brazil Local Networking Group

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------

Hi Carolina

You can register the device accessory together with the device in the same registration, and, if the accessory itself is a medical device (what ANVISA call a "part" or if the accessory is not exclusive to the device in question), you will also need to register the accessory separately.

You should read "Manual para regularização de equipamentos médicos na Anvisa" - https://tinyurl.com/y6mu43bp (look for - Produtos que podem ficar incluídos no registro ou cadastro do equipamento) for a morre in depth (albeit a little confusing :-)) explanation.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
------------------------------

Original Message:
Sent: 25-Sep-2019 12:27
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------

Thank you Marcelo. It helped. 

I do have another question on this, hoping you or somebody else in RAPS community could help me.

For importing in Brazil, is it allowed to put the part or accessory (manufactured by an OEM) in the box together with the MD? Or it should be wrapped to the MD box, having each one, the MD and part/accesory its own labeling?

Thank you!

------------------------------
C.Oviedo
RA Executive
------------------------------

Original Message:
Sent: 25-Sep-2019 20:00
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

Hi Carolina

You can register the device accessory together with the device in the same registration, and, if the accessory itself is a medical device (what ANVISA call a "part" or if the accessory is not exclusive to the device in question), you will also need to register the accessory separately.

You should read "Manual para regularização de equipamentos médicos na Anvisa" - https://tinyurl.com/y6mu43bp (look for - Produtos que podem ficar incluídos no registro ou cadastro do equipamento) for a morre in depth (albeit a little confusing :-)) explanation.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 25-Sep-2019 12:27
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------

If the part or accessory is not a medical device in itself, you can include it in the MD. If it is a medical device in itself, generally (in particular if you have to register it separately) you need the they have their own labeling and package.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
------------------------------

Original Message:
Sent: 08-Oct-2019 18:47
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Thank you Marcelo. It helped.

I do have another question on this, hoping you or somebody else in RAPS community could help me.

For importing in Brazil, is it allowed to put the part or accessory (manufactured by an OEM) in the box together with the MD? Or it should be wrapped to the MD box, having each one, the MD and part/accesory its own labeling?

Thank you!

------------------------------
C.Oviedo
RA Executive

Original Message:
Sent: 25-Sep-2019 20:00
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

Hi Carolina

You can register the device accessory together with the device in the same registration, and, if the accessory itself is a medical device (what ANVISA call a "part" or if the accessory is not exclusive to the device in question), you will also need to register the accessory separately.

You should read "Manual para regularização de equipamentos médicos na Anvisa" - https://tinyurl.com/y6mu43bp (look for - Produtos que podem ficar incluídos no registro ou cadastro do equipamento) for a morre in depth (albeit a little confusing :-)) explanation.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 25-Sep-2019 12:27
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------

Thank you again Marcelo.

Is there some regulation in Brazil that explain this?

------------------------------
C.Oviedo
RA Executive
------------------------------

Original Message:
Sent: 09-Oct-2019 06:17
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

If the part or accessory is not a medical device in itself, you can include it in the MD. If it is a medical device in itself, generally (in particular if you have to register it separately) you need the they have their own labeling and package.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 08-Oct-2019 18:47
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Thank you Marcelo. It helped.

I do have another question on this, hoping you or somebody else in RAPS community could help me.

For importing in Brazil, is it allowed to put the part or accessory (manufactured by an OEM) in the box together with the MD? Or it should be wrapped to the MD box, having each one, the MD and part/accesory its own labeling?

Thank you!

------------------------------
C.Oviedo
RA Executive

Original Message:
Sent: 25-Sep-2019 20:00
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

Hi Carolina

You can register the device accessory together with the device in the same registration, and, if the accessory itself is a medical device (what ANVISA call a "part" or if the accessory is not exclusive to the device in question), you will also need to register the accessory separately.

You should read "Manual para regularização de equipamentos médicos na Anvisa" - https://tinyurl.com/y6mu43bp (look for - Produtos que podem ficar incluídos no registro ou cadastro do equipamento) for a morre in depth (albeit a little confusing :-)) explanation.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 25-Sep-2019 12:27
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------

No, but it's explained in the manual I mentioned before.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
------------------------------

Original Message:
Sent: 09-Oct-2019 11:09
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Thank you again Marcelo.

Is there some regulation in Brazil that explain this?

------------------------------
C.Oviedo
RA Executive

Original Message:
Sent: 09-Oct-2019 06:17
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

If the part or accessory is not a medical device in itself, you can include it in the MD. If it is a medical device in itself, generally (in particular if you have to register it separately) you need the they have their own labeling and package.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 08-Oct-2019 18:47
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Thank you Marcelo. It helped.

I do have another question on this, hoping you or somebody else in RAPS community could help me.

For importing in Brazil, is it allowed to put the part or accessory (manufactured by an OEM) in the box together with the MD? Or it should be wrapped to the MD box, having each one, the MD and part/accesory its own labeling?

Thank you!

------------------------------
C.Oviedo
RA Executive

Original Message:
Sent: 25-Sep-2019 20:00
From: Marcelo Antunes
Subject: Registration of a device with an accessory manufactured by an OEM

Hi Carolina

You can register the device accessory together with the device in the same registration, and, if the accessory itself is a medical device (what ANVISA call a "part" or if the accessory is not exclusive to the device in question), you will also need to register the accessory separately.

You should read "Manual para regularização de equipamentos médicos na Anvisa" - https://tinyurl.com/y6mu43bp (look for - Produtos que podem ficar incluídos no registro ou cadastro do equipamento) for a morre in depth (albeit a little confusing :-)) explanation.

------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 25-Sep-2019 12:27
From: Carolina Oviedo
Subject: Registration of a device with an accessory manufactured by an OEM

Dear Brazil Community

Could you advice on registration requirements for a medical device intended to be sold together with an accessory which is manufactured by an OEM?

I did consult RDC 185/2001 PART 3 – Procedures for Registration, section 12; this section indicates that "The medical product and its accessories shall have the same manufacturer.". But I didn´t find in the regulation the scenario for accessories manufactured by OEMs.

Thank you!



------------------------------
C.Oviedo
RA Executive
------------------------------