Registration Process Guidance for Custom-Made Medical Devices in South/Latin America

F

FR_md24

#1
Dear all,

is there a particular regulation or procedure for custom-made medical devices in South America? Is the registration process the same as all other medical devices or there are specific dispositions (like in EU or Australia)?

Thank you very much
 
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Marcelo

Inactive Registered Visitor
#2
Re: Registration Process for Custom-Made Medical Devices in South America

There are no "South-America" regulations, each country has its own regulations (as is the case of the rest of the world).

In Brazil, for example, custom-made devices follows the general registration procedures.
 
F

FR_md24

#3
Re: Registration Process for Custom-Made Medical Devices in South America

Thank you!
I am aware that no overall South America regulatory framework exists.

However, I can't find any specific information about custom-made medical device regulations in South America countries, so I am led into thinking that they follow the general registration procedures.

Do you know if other countries (i.e. Mexico, Chile, Argentina, Colombia, Venezuela) have specific regulations?

Thank you again!
 

Marcelo

Inactive Registered Visitor
#4
Re: Registration Process for Custom-Made Medical Devices in South America

However, I can't find any specific information about custom-made medical device regulations in South America countries, so I am led into thinking that they follow the general registration procedures.

Do you know if other countries (i.e. Mexico, Chile, Argentina, Colombia, Venezuela) have specific regulations?
Yes, sorry, you are right in this line of thought. I made review in the past and did not find any particular requirement for custom-made devices (I only know that ANVISA applies the general registration procedure because I asked them directly).

I?ve just performed another quick review on the old and new regulations for different countries and also did not find any specific.

So yes, in general they probably use the same registration procedure, unless there?s some obcure regulation that I don?t now about.
 
D

dallltho

#5
Re: Registration Process for Custom-Made Medical Devices in South America

Marcelo, I have been told that Custom-made (prescription products prescribed directly and made uniquely for 1 patient) requires some sort of authorization outside of the normal ANVISA registration process. Do you know if that is true? Since we both speak Portuguese, is there any Norma Instrutiva in Portuguese from ANVISA that offers any more information on this topic?

Thanks,

P.S. Regarding your review of the Latin America requirements for Custom devices, did you find anything for Mexico or Argentina? Any information or direction on how I can find out more information would be helpful.
 
D

dallltho

#6
Guidance on Custom Devices in any Latin American Country: Brazil, Argentina, Colombia

Hello and que tal.
Just reaching out to see if anyone has found any good documents or guidances on Custom Devices (dispositivos recetados y hechos a la medida para pacientes especificos) and their requirements or exemptions from these countries. I am particularly looking for Colombia at present but if you know of others from ANVISA, COFEPRIS, ANMAT, etc please let me know.
 

Marcelo

Inactive Registered Visitor
#7
Re: Registration Process for Custom-Made Medical Devices in South America

Marcelo, I have been told that Custom-made (prescription products prescribed directly and made uniquely for 1 patient) requires some sort of authorization outside of the normal ANVISA registration process. Do you know if that is true? Since we both speak Portuguese, is there any Norma Instrutiva in Portuguese from ANVISA that offers any more information on this topic?
For custom-made orthopedic devices, you do not follow the registration procedure, however, you need to send clinical justification information to ANVISA, and they will give an authorization. For others, you do follow the normal registration process.

And no, there?s no guidance on that, unfortunately.

P.S. Regarding your review of the Latin America requirements for Custom devices, did you find anything for Mexico or Argentina? Any information or direction on how I can find out more information would be helpful.
Nope, sorry!
 

Marcelo

Inactive Registered Visitor
#8
Re: Registration Process for Custom-Made Medical Devices in South America

As I?ve put in another thread, I?ve just made another review on Colombia and found some info:

Now that you mention it, I did a quick review of Colombian requirements and ended up finding some stuff.

Here are two documents, on for GMP for custom-made orthopedic devices and one for custom-made eye devices.

However, I did not find other info. It seems that those devices do not need registration, however, the manufacturers do have to register the plants and have to fulfill the mentioned regs.
 
F

FR_md24

#9
Re: Registration Process Guidance for Custom-Made Medical Devices in South/Latin Amer

Thank you very much!
 

tibon74

Involved In Discussions
#10
Re: Registration Process for Custom-Made Medical Devices in South America

Hi Marcelo,

If a custom instrument is used for the implantation of orthopedics implant (approved in brazil), should we follow the usel registration process?

thank you!
 
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