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

Obtain approval in

Lebanon

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