Oman Medical Device Regulations

Agency
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
Postmarket Surveillance Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities required.
Timeline Two years
Need More Information