Medical Device Registration in Venezuela

M

mjain

#1
Hello,

I am looking to register my medical device in Venezuela. Unfortunately the ministry of health site does not show any medical device regulation and I cannot find any other government webiste (("OICEMP") to provide this information.

Has anyone registered a medical device in Venezuela? Please share any insights :)

thank you so very much in advance for all the time and help.

Megha
 
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Ajit Basrur

Staff member
Admin
#2
Hello,

I am looking to register my medical device in Venezuela. Unfortunately the ministry of health site does not show any medical device regulation and I cannot find any other government webiste (("OICEMP") to provide this information.

Has anyone registered a medical device in Venezuela? Please share any insights :)

thank you so very much in advance for all the time and help.

Megha
Welcome to the Cove :bigwave:

We have information on Medical Devices in Venezuala here - http://elsmar.com/Forums/showthread.php?t=37792
 
M

mjain

#3
Thank you Ajit for your kind response. I have studied the thread mentioned in your post; I wanted to be pointed to the regulation/ web site where this information is explicitly mentioned. Would you be able to guide me?
Thank you again for all your help.

Megha
 
M

mjain

#5
thank you both for all the help. I will study this topic a bit more and share any insight with all.

Megha
 
C

cjr978

#6
I realize its a bit late - but in my experience Venezuela do indeed take noticable time.

For some reason their authorities like to split things out in to multiple small registrations some of which go through quickly and others can take up to about 4 months or so.

The documents required are pretty minimal, CFG's, certificate of analysis that kind of thing.

Beware their upcoming labelling requirements, which if they do end up in force means that the registration number will have to appear on the labels of your products. Currently our people on the ground there are saying those requirements aren't imminent (but that situation could change without warning)
 
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