Morocco Medical Device Product Registration

T

Tiffany

Hi mates,

Knowing that Morocco is going to regulate medical devices registration soon and wondering they will also implying the local representative for registration and any specific technical documentation required for registration? Is this local representative meant must be distributor and only one local representative allow?

By the way any guidelines for Morocco product regiatration that could have better picture and procedures on this?

:thanx:

Tiffany
 
Z

Zandra

I want to know the same thing!
I'm searching and searching but no informations!
Please help us :(

Thank you
 
T

theondine

Hi all,

the enforcement date of the regulations in Morocco is expected to be September 2014. Please see attached the regulation I received recently.
It is in French, but a good start, hopefully.
 

Attachments

  • BO_6188_Fr Loi relative aux Dispositifs Médicaux.pdf
    2 MB · Views: 585
S

sreenu927

Quite Involved in Discussions
Morocco accepts CE Marking. So you can submit the technical file or design dossier for registering your medical device or IVD in Morocco.
For translation, it accepts French labeling.

Hope this helps!

Regards,
Sreenu
 
P

philou49

Hi Everybody
I have collected different documents (in french) if its help someone...
I have on my side some questions unsolved:
Who is the owner of the registration : Manufacturer, importer, distributor ?
Who is supposed to register ?
If we have multiple distributor do we need multiple registration ?
If the device are X-ray generator, is there any specific requirement in Moroco ?
Is there somewhere on the web a accessible database for registred product in moroco ?
 

Attachments

  • Liste pour composition dossier DMP.pdf
    642.8 KB · Views: 326
  • fiche signaletique (nouvelle).doc
    22.5 KB · Views: 240
H

helloferoz

Hello All

I am in the same Boat as you guys are, there isnt anything on Morocco MOH website and neither any authentic source of information. I need information about how to register a product in Morocco? What documentation is required?
How classification of the products are regulated? How import and Export regulations work?

Please if some one has some good information it would be much appreciated if you can share it.

I need this information at the earliest possible as i am looking to register many innovative products in Morocco.

Thanks
FAZ
 
A

apuigvert

Involved In Discussions
helloferoz said:
Hello All

I am in the same Boat as you guys are, there isnt anything on Morocco MOH website and neither any authentic source of information. I need information about how to register a product in Morocco? What documentation is required?
How classification of the products are regulated? How import and Export regulations work?

Please if some one has some good information it would be much appreciated if you can share it.

I need this information at the earliest possible as i am looking to register many innovative products in Morocco.

Thanks
FAZ
Click to expand...

Hello! What I know so far is that the regulation is quite similar to the 93/42/EEC (currently replaced by the MDR). You need an authorized representative, and the product must be CE marked to be approved in Morocco. I hope this helps.
 
S

Sicco

Involved In Discussions
Hello,
we register devices through our distributor in Morocco.
Basically they asked us for below list of items. Registration was made base on our EC certificate.
  • DoC with accessories and REF/ID numbers for each article.
  • EC Certificate
  • GMDN code
  • ISO13485 Certificate
  • Authorization Letter
  • Labelling
  • User-Manual
  • Advertisement materials - catalogues/leaflets/One sheeter
 
A

apuigvert

Involved In Discussions
Hello all, I am trying to obtain information about the importation scheme in Morocco. If the registration is done through one distributor, is it possible for another distributor to import the product using the same license? For example, if the distributor that owns the license issues a letter authorizing the second one to import the device. Thanks!
 
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