Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All, 


Does anyone have experience of selling medical devices into Azerbaijan or Morocco ? can you give any advice ?which regulations do we need to follow and where can we access these regulations. 

thanks very much in advance

For Morocco, you can find the regulations on the health ministry website​, available in Arabic and French.
https://www.sante.gov.ma/Reglementation/Pages/REGLEMENTATION-APPLICABLE-AU-PRODUITS-DE-SANTE.aspx

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 04-Feb-2021 08:25
From: Anonymous Member
Subject: Azerbaijan and Morrocco

This message was posted by a user wishing to remain anonymous

Hi All,


Does anyone have experience of selling medical devices into Azerbaijan or Morocco ? can you give any advice ?which regulations do we need to follow and where can we access these regulations.

thanks very much in advance

Hello,

For Azerbaijan there is no medical device specific information, so might need a local person to assist, but MOH: http://www.sehiyye.gov.az/ and the healthcare/pharma page: http://www.pharma.az/.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 04-Feb-2021 09:39
From: Anne LeBlanc
Subject: Azerbaijan and Morrocco

For Morocco, you can find the regulations on the health ministry website​, available in Arabic and French.
https://www.sante.gov.ma/Reglementation/Pages/REGLEMENTATION-APPLICABLE-AU-PRODUITS-DE-SANTE.aspx

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 04-Feb-2021 08:25
From: Anonymous Member
Subject: Azerbaijan and Morrocco

This message was posted by a user wishing to remain anonymous

Hi All,


Does anyone have experience of selling medical devices into Azerbaijan or Morocco ? can you give any advice ?which regulations do we need to follow and where can we access these regulations.

thanks very much in advance

Hello,

In Azerbaijan you will need to get Hygienic certificate locally for importation. Local importer should be able to do so. Documentation is provided in English or Russian or Azer language. Might take up to 1 month.
Labeling should be in Azer or English or Russian language. Turkish is also accepted.
IFU has to be in Azer language. At least you should be able to provide it if clinics requests. Especially for a higher risk products.
This is for MD.
For pharma products regulation is more complicated.
Hope that helps
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 04-Feb-2021 08:25
From: Anonymous Member
Subject: Azerbaijan and Morrocco

This message was posted by a user wishing to remain anonymous

Hi All,


Does anyone have experience of selling medical devices into Azerbaijan or Morocco ? can you give any advice ?which regulations do we need to follow and where can we access these regulations.

thanks very much in advance