Medical Device Registration in
Ministry of Health
The General People’s Committee for Health and Environment
Medical Device Regulation
Libyan Regulation for Medical Devices
The Libyan authorities accept all classification systems
- 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
- 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.
Labels and IFUs should be in Arabic or English