Lebanon Medical Device Regulations

All medical devices are regulated by The Ministry of Public Health (MOPH)
Classification of Medical Device
International Classification Examples Risk Level
A Chemistry analyzer Low
B Urine test strips Low - Moderate
C Blood Glucose self-testing High - Moderate
D HIV blood analyzer High
Premarket Approval Process
Appoint an authorized representative (AR) in Bahrain to submit application.
Fill out application form and submit all required documents (listed below).
If approved, applicant will receive a registration certificate
List of Required Documents
  • Application
  • CE certificate copy
  • CFS
  • Quality Management System ISO 13485
  • User manual
  • Declaration of conformity
  • Distribution agreement covering the Territory of Lebanon signed by both parties and notarized/legalized by Lebanese Embassy in C.O.O
Additional Information
Postmarket Surveillance Some controls in place
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