Oman Medical Device Regulations

REGULATORY AUTHORITY:

All medical devices are regulated by the Directorate General of Medical Supply, Ministry of Health.

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 a local authorized representative (AR) in Oman to submit application (required).
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 (DoC)

Additional Information

Validity	Five years
Postmarked Surveillance	Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities required.
Timeline	Two years