Medical Device Registration in
Oman
Ministry of Health:
Ministry of Health, Oman
Regulatory Authority:
Directorate General of Medical Device Control
Medical Device Regulation:
Law Royal Decree 35/2015
Official Language:
Arabic
Classification:
Class A, B, C and D
Registration Process:
- Appoint an Authorized Representative
- Complete the application form and submit all the required documents
- Once approved, the applicant will receive a Registration Certificate
Documents Required:
- Application Form
- CE certificate
- Free Sales Certificate
- QMS certificate
- User Manual, Labels or Package Inserts
- Declaration of Conformity
Legalized/Notarised Documents (if any)
Free Sales Certificate
Applicable QMS:
ISO 13485
Registration Timeline:
2 years
Authorized Representative:
Yes
License Validity:
5 years