The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Requirements for Exporting Medical Devices to Libya

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
exports and exporting, libya, libyan ministry requirements, medical devices
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  Post Number #1  
Old 21st January 2011, 07:33 AM
Burgmeister

 
 
Total Posts: 105
Question Requirements for Exporting Medical Devices to Libya

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
Thanks to Burgmeister for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 22nd January 2011, 10:48 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Requirements for Exporting Medical Devices to Libya

Quote:
In Reply to Parent Post by Burgmeister View Post

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.
  Post Number #3  
Old 22nd January 2011, 11:04 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Look! Re: Requirements for Exporting Medical Devices to Libya

Refer my earlier post - Medical Device Registration requirements for Algeria and Libya

Also some FAQs on Libya HERE

.
  Post Number #4  
Old 22nd January 2011, 12:13 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Requirements for Exporting Medical Devices to Libya

Quote:
In Reply to Parent Post by Ajit Basrur View Post

Refer my earlier post - Medical Device Registration requirements for Algeria and Libya

Also some FAQs on Libya HERE
Both of those resources pertain to US Government rules...not relevant to medical device registration and regulation by Libya, and in any case not relevant to export from UK, i.e. the EC, to Libya.

Also, US exporters might want to note that some of that information may predate the current State Department stance vis-a-vis Libya.
  Post Number #5  
Old 22nd January 2011, 01:09 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Requirements for Exporting Medical Devices to Libya

This English-language website http://www.libyaonline.com/guide/gui...w=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.p...d=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.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #6  
Old 24th January 2011, 05:18 AM
Burgmeister

 
 
Total Posts: 105
Re: Requirements for Exporting Medical Devices to Libya

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.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Regulatory Requirements for Exporting Medical Devices to Bonaire emceedi EU Medical Device Regulations 1 13th July 2018 10:33 AM
Exporting Add-On for Medical Devices to the US - FDA Requirements Jojo63 Other Medical Device Related Standards 3 9th July 2014 10:51 AM
Requirements for Exporting Medical Devices to Australia Bridget Various Other Specifications, Standards, and related Requirements 25 7th December 2012 04:06 PM
Requirements for Exporting Class III Medical Devices into the UAE from the US or EU regina_q ISO 13485:2016 - Medical Device Quality Management Systems 2 23rd July 2012 10:36 AM
Pre-Approval Requirements - Exporting Medical Devices to China from the US Sarah-Shangh China Medical Device Regulations 4 4th March 2012 09:58 PM



The time now is 10:00 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"