Legal requirement for same indications as in Country of Origin

Chinquada

Starting to get Involved
#1
Hi, I need to know, if there is any legal requirement to register the same indications for a medical device as approved in the country or origin.
In case yes, could you please make a reference as to the law/guidance and country where such a requirement exists?
I am especially interested, if such a "written requirement" would be available for the region of Latin America.

Your help and feed-back is much appreciated.
Thanks a lot in advance,
Chinquada
 

somashekar

Super Moderator
Staff member
Super Moderator
#2
Hi, I need to know, if there is any legal requirement to register the same indications for a medical device as approved in the country or origin.
In case yes, could you please make a reference as to the law/guidance and country where such a requirement exists?
I am especially interested, if such a "written requirement" would be available for the region of Latin America.

Your help and feed-back is much appreciated.
Thanks a lot in advance,
Chinquada
Hi ..
I believe you are talking about the intended use of the Medical device.
The is no such legal requirement for any uniformity across regions.
Its the Manufacturer who determines the intended use and supports with all credentials to meet the said intended use to the regulators.
Were you looking for this ....or am I missing something in your question.
 

Chinquada

Starting to get Involved
#3
Yes, I am talking about the intended use of a Medical Device. Especially about global registrations in various regions. In most countries part of registration is a Free Sales Certificate. Do you know a legal requirement to have the same intended use registered as in the country, that issued the Free Sales Certificate?
 

somashekar

Super Moderator
Staff member
Super Moderator
#4
Yes, I am talking about the intended use of a Medical Device. Especially about global registrations in various regions. In most countries part of registration is a Free Sales Certificate. Do you know a legal requirement to have the same intended use registered as in the country, that issued the Free Sales Certificate?
As far as I know, the free sale certificate is issued to whatever you describe as the device name and model in your application. There is no question about intended use in this certification issue.
 

sreenu927

Quite Involved in Discussions
#5
Yes. If you are registering in a country based on registration approval of another country, then the intended use must be the same. I don't remember anything specific in regulations at this moment, however, the guidance documents would definitely mention about this requirement.
Otherwise, if different intended use, then considered as two separate products that will force to the manufacturer to have 2 separate SKU/REF #, Design Master file, etc..
But again it depends on which country are you referrring to; some may accept with justifications on similarities/differences between 2 intended uses of same product. Also need to consider if it is a medical device or an IVD (IVD vs RUO).

And in some countries, in FSC application, intended use statement has to be indicated.

Regards
Sreenu
 
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