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
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