Lebanon Medical Device Regulations

Agency
All medical devices are regulated by The Ministry of Public Health (MOPH)
Classification of Medical Device
International ClassificationExamplesRisk Level
AChemistry analyzerLow
BUrine test stripsLow - Moderate
CBlood Glucose self-testingHigh - Moderate
DHIV blood analyzerHigh
Premarket Approval Process
ABCD
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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