Venezuela Medical Device Labeling Requirements

[cjr978]

I understand the Venezuela recently made mandatory requirements for the labelling of medical devices (such as having the product description in writing and the registration number on the label).
Can anyone point me in the direction of information about this, specifically what label information is required exactly, at what stage it is required (importation, or at the point of use) and possibly even work arounds to make life easier for our freight forwarder.
thanks

 

[Ajit Basrur]

I understand the Venezuela recently made mandatory requirements for the labelling of medical devices (such as having the product description in writing and the registration number on the label).
Can anyone point me in the direction of information about this, specifically what label information is required exactly, at what stage it is required (importation, or at the point of use) and possibly even work arounds to make life easier for our freight forwarder.
thanks

Take a look here - http://www.medical-promek.com/regMed_Venezuela.php

You can officially contact the regulatory body in Venezuala at

Oficina de Inscripcion y control de equipos y Material
Medico Paramedico ("OICEMP")
Torre Sur, Piso 8, Oficina 821,
Centro Simon Bolivar,
Caracas 1010, Venezuala,

Phone - (011) 58212 408-0012
Fax - (011) 58212 483-4219

Disclaimer - I have no connection with the weblink and came across through a search engine.

 

[cjr978]

Thanks for the quick reply, this wasnt quite the information i was looking for. I believe Venezuela have very recently introduced new requirements (possibly just regarding shipping containers on import).

best regards
Chris

 

[Ajit Basrur]

Thanks for the quick reply, this wasnt quite the information i was looking for. I believe Venezuela have very recently introduced new requirements (possibly just regarding shipping containers on import).

best regards
Chris

I suggest you to contact the OICEMP then

 

[Marco L.]

I would like to have an information about user?s manual of medical devices. Can manufacturers provide instructions for use in electronic format only and replace the paper copy? What type of medical device can be accompanied by electronic instructions for use?

Thank you very much!!

Marco

 

[ljuliadavila]

I am intersted in finding out about Marco's question as well. Can you replace manuals with electronic versions (flash drive or a card refering to the manufacturers site, etc)

Thanks!

 

[Marcelo]

I am intersted in finding out about Marco's question as well. Can you replace manuals with electronic versions (flash drive or a card refering to the manufacturers site, etc)

There?s still only a few medical devices regs in Venezuela a none give this option, so I would say that it?s not possible.