Requirements for Exporting Medical Devices to Libya

Burgmeister

Involved In Discussions
#1
Hi all.

I wonder if there are any people on here whose company exports medical devices to Libya? If so, are there any requirements for registering your devices IN LIBYA? I am happy that I understand the controls this end (UK), but I am getting conflicting information regarding Libyan Ministry requirements. Unfortuantely I can't find any information directly from a Libyan government source so I would be grateful for any info from anyone with experience in this area.

Thanks
 

Stijloor

Super Moderator
Staff member
Super Moderator
#2
Hi all.

I wonder if there are any people on here whose company exports medical devices to Libya? If so, are there any requirements for registering your devices IN LIBYA? I am happy that I understand the controls this end (UK), but I am getting conflicting information regarding Libyan Ministry requirements. Unfortunately, I can't find any information directly from a Libyan government source so I would be grateful for any info from anyone with experience in this area.

Thanks
Can someone help?

Thank you!!

Stijloor.
 

MIREGMGR

Inactive Registered Visitor
#4

MIREGMGR

Inactive Registered Visitor
#5
This English-language website http://www.libyaonline.com/guide/guide.php?page=1&show=33&userid=49 has a listing of Libyan governmental agencies and ministries, with phone numbers and websites.

The governmental website system seems to be quite comprehensive. I don't find any mention of medical device import registration or regulation on the sites for the Ministry of Economy and Trade. At the Ministry of Health and Environment site, the limited English language subsite lists a Directorate for Drugs and Medical Equipment, with a Department for Medical Equipment and Supplies and another one for Registration and Inspection.

By drilling down at the Arabic site with the help of Google-translate, I found the terms-and-conditions document for Tender #39, which I gather is the annual purchasing program of the governmental health system for imported pharma and devices. There is an English-language requirements document (the regular one is English, the "detailed" one is Arabic) on this page: http://www.health.gov.ly/web/index.php?option=com_docman&task=cat_view&gid=38&Itemid=77. It makes reference, in the Technical File section, to requirements for:

B) - (ISO) & (GMP) certificates for sterile Medical devices ;
C) ISO certificate from the manufactures of the laboratory reagents and
Devices .


It sounds to me as if Libya follows what my company calls a "third tier" approach, in that they accept documentation from a supplier of a manufacturer's conformance to a first tier regulatory system (in this case, ISO 13485) as sufficient to establish that devices from that manufacturer are acceptable for import and use.

I'd guess that a CE certificate would be helpful as well, though it isn't called out.

I don't see any indication of a requirement for registration of the external supplier. Perhaps, as in several other Arabic-culture countries, there is a separate requirement for registration of the local importing company as an agent of the external supplier, with regulation applied to the local importer.
 

Burgmeister

Involved In Discussions
#6
Thanks Miregmgr. Most helpful. I have sent an email to the Health Department in Libya to seek confirmation of the process. Whether they reply or not is another matter......

If they do reply I will post the response here so that it may help others who come across this in the future. Given that UKTI is positively promoting Libya as a 'place to do business' it may well be something fellow members of this forum come across.
 

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