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Oman

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

Guidance

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

Want to know more about this registration process?