Cost or Fees to Register Medical Devices in Venezuela

Z

zhang126

#1
hi!

what is the cost or fees to register medical devices in Velezuela?

Class 1
Class 2
Class 3

And timeline of the registration process?
 
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Marcelo

Inactive Registered Visitor
#2
As far as i know (i´ve never done a registration in Venezuela, but i´ve read the regulation) there´s no official fees for the registration...you will need to pay for the translation of documents (in castellano) and for some certificates, but there´s no registry fee.

The regulation says that the Health Ministry has 20 days, after you send all the necessary documentation, to decide to give the registration (or not, if tyhe documentation lacks what it´s needed). Again, i´ve n opractical experience, but as the regulation is simple (basically documentation) i would say that it can be done very quickly indeed.
 

bio_subbu

Super Moderator
#3
Hi

There are several agencies are involved in the Venezuelan medical device regulation

1. MPPS (Ministry of Health) - The Ministerio del Poder Popular para la Salud

2. SACS - (Autonomous Service of Sanitary Controllership)- The Servicio Autonomo de Contraloria Sanitaria

3. OICEMP –¬ (Formerly the Office of Registration and Control for Medical and Paramedical Equipment and Supplies)

4. INHRR (The Instituto Nacional de Higiene Rafael Rangel)

But there is no official fee for registration, you need to pay for official bank in order to process sanitary registration, INHRR for medical device analysis (if applicable), Private lab testing, Translation fees and Global service fees.

Regards
S. Subramaniam
 
R

Raymond12

#4
Dear all,

Please could someone help me with regard to changing registration holder in Mexico. What are teh regulations/ process?

Any help would be greatly appreciated

Many thanks in advance
Ray
 

bio_subbu

Super Moderator
#5
Dear all,

Please could someone help me with regard to changing registration holder in Mexico. What are teh regulations/ process?

Any help would be greatly appreciated

Many thanks in advance
Ray
Hi Ray

Emergo Group has written an article on “Regulatory process for marketing medical devices in Mexico” and the article available in their website. I think the details for changing regulator is mentioned, please refer here.

Regards
S. Subramaniam
 
Last edited:
R

Raymond12

#6
Thank you for this information,

on the website it states 'The process of transferring a medical device registration in Mexico is simple and discussed in Article 190 of Reglamento de Insumos para la Salud'

I have tried searching for this but cant seem to find it. Do you know what is stated in this article?

Many thanks

Ray
 
R

Rollo1962

#7
As far as i know (i?ve never done a registration in Venezuela, but i?ve read the regulation) there?s no official fees for the registration...you will need to pay for the translation of documents (in castellano) and for some certificates, but there?s no registry fee.

The regulation says that the Health Ministry has 20 days, after you send all the necessary documentation, to decide to give the registration (or not, if tyhe documentation lacks what it?s needed). Again, i?ve n opractical experience, but as the regulation is simple (basically documentation) i would say that it can be done very quickly indeed.
Dear Marcelo,
I hope you can help me in understanding some aspects of Venezuelan regulation.
In particular, could you please confirm if foreign manufacturer, that want to distribute in Venezuela, need to have a local authorized representatives, and if this representative could be the local distributor? The product registration to OICEMP is made in the name of the foreign manufacturer or in the name of the local representative? And finally, which is the impact in changing a local representative and distributor (e.g., the registration need to be repeated, a simply notification must be forwarded to OICEMP, others)?
Thank you in advance for the attention and time you will take on this request.
Very best regards.
Rolando
 

Marcelo

Inactive Registered Visitor
#8
You need someone in Venezuela to register your device. Please note that this in fact is not an authorized representative, because it has full responsibility for the device (people think the same in Brazil, meaning, they think the Brazilian entity is an representative, like in Europe, but it's not, as it has full responsibility over the device). This could be the local distributor. The registration is made in the name of the Venezuelan entity. And if you change the entity, you need to repeat the registration with another entity (and the original entity will maintain the registration during the 5 years period of registration.
 
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