Can there be multiple Brazil Registration Holder (BRH) for same model ?

Y

youuu

#1
Hello everyone:bigwave:

I have a question regarding BRH (Brazil Registration Holder) for ANVISA registration.
Brazil's medical device certification is taking too much time so I was wondering if the company could have multiple BRHs for same models.
Or is one company restricted to having one BRH?

Thank you very much in advance!:thanx:
 
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Ajit Basrur

Staff member
Admin
#2
Hello everyone:bigwave:

I have a question regarding BRH (Brazil Registration Holder) for ANVISA registration.
Brazil's medical device certification is taking too much time so I was wondering if the company could have multiple BRHs for same models.
Or is one company restricted to having one BRH?

Thank you very much in advance!:thanx:
Welcome youuu :bigwave:

Per Emergo, http://www.emergogroup.com/services/brazil/brazilian-registration-holder

The BRH will ?own? not only the registration but also the GMP certification and only the BRH can grant permission for others to import using the approval in their name. Please note, once a BRH is assigned to the device, it cannot be transferred for commercial reasons (i.e. you wish to switch distributors) and can only be transferred, for example, if two companies merge or one is spun off the other. If you select us as the BRH, we will be identified on the registration and would fully cooperate with you so that you control the approval of your device and who can and cannot import your products.

Disclaimer : I do not belong to Emergo and in no way advertise for Emergo.
 

Cindy

Registered
#4
Yes, you can have more than one, for exampe, if you are insatisfied with one you can begin the process for egistration with another, but it?s not expected to be a permanent arrangement, only a transitional one.
Hi, Marcelo!
I am Cindy working at medical device manufacturer in South of Korea.
Could the company still have multiple BRHs for same models? Is it still valid now? Where can I find this information in ANVISA regulations?
 
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