Lebanon Medical Device Regulations

Agency
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
A B C D
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