Medical Device Registration in
Lebanon
Ministry of Health
Regulatory Authority
Ministry of Public Health
Official Language
Arabic
Classification
Class I, II and III
Medical Device Registration in Lebanon
- 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