Medical Device Registration in
Libya
Ministry of Health
Regulatory Authority
The General People’s Committee for Health and Environment
Medical Device Regulation
Libyan Regulation for Medical Devices
Official Language
Arabic
Classification
The Libyan authorities accept all classification systems
Medical Device Registration in Libya
- The registration procedure is conducted as part of an annual purchasing program for imported medical Devices.
- The registration process must be carried out by a local representative
Documents Required
- Annex No. (5) of Tender No. 17 – 2011 (Annex XVI),
- Technical Documentation
- ISO and GMP certificates for sterile medical Devices, certificates and methods of analysis for the final product,
- Stability study for the final product,
- Accompanied sample’s CoA
- Samples of the final product to carry out three complete tests.
Applicable QMS
Authorized Representative
Yes
Special Notes
Labels and IFUs should be in Arabic or English