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Lebanon Medical Device Regulations


Regulatory Authority

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 Lebanon 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

 

Post market Surveillance

Some controls in place