In Venezuela, do I have to register Molecular diagnostics kits or IVD kits?

[Leo Gustaf Damien]

Hello. I would like to ask some help.

I'd like to know, If I want to sell Molecular diagnostics kits or reagents in Venezuela,
do I have to register my Molecular diagnostics kits or reagents
(ex : Influenza diagnostics kits, Salmonella diagnostics reagent kit, IVD reagents, etc.) in MOH Venezuela or something?

I mean the Molecular diagnostics kits or reagents (ex : Influenza diagnostics kits, etc.) also have to be registered to sell the kits in Venezuela?
I already know some Medical Devices with electricity have to be registered tho.
but especially my kits & reagents have to be registered?


May I also have information about regulation and registration in Venezuela for the kits and reagents ?
I cannot find information on google but the posts in the Elsmar Cove Forums of 2007 and 2012 (Cost or Fees to Register Medical Devices in Venezuela
& Medical Device Registration in Venezuela)

It seems the Venezuela government haven't announced any detail information about the regulation for IVD. I wish I could get any information about the regulation as possible.

Thank you a lot!!



In Venezuela, IVD, Molecular Diagnostics Kit, Reagents, Regulations, Registrations, Venezuela, medical devices (general), Molecular Diagnostics

 

[Marc]

I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.