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 ClassificationExamplesRisk Level
AChemistry analyzerLow
BUrine test stripsLow - Moderate
CBlood Glucose self-testingHigh - Moderate
DHIV blood analyzerHigh
Premarket Approval Process
ABCD
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
ValidityFive years
Postmarket Surveillance Implementation of post market surveillance systems, adverse incident reporting programs and vigilance activities required.
TimelineTwo years
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