Ministry of Health

Ministry of Public Health

Regulatory Authority

Ministry of Public Health

Official Language

Arabic

Classification

Class I, II and III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative or Distribution partner
• Prepare the Technical Documentation and submit to MoPH
• Once approved, the device can be marketed in Lebanon.

Documents Required

• Technical Documents
• Certificate of Free Sales
• CE or US FDA certificate
• QMS or GMP certificate
• Certificate of Analysis
• 2 samples
• Stability data of 1 batch from manufacture to expiry date
• Storage conditions
• Summary of product characteristics or Leaflet
• Distribution agreement
• Company Profile

Legalized/Notarised Documents (if any)

• QMS or GMP certificate
• Distribution agreement

Applicable QMS

ISO 13485

Registration Timeline

3 – 6 months

License Validity

Does not expire