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Lebanon

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Lebanon

Medical Device Registration in Lebanon

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

Want to know more about this registration process?

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