Ministry of Health

Ministry of Health (Libya)

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

Registration Process

• 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

ISO 13485:2016

Authorized Representative

Yes

Special Notes

Labels and IFUs should be in Arabic or English