Medical Device Regulatory Requirements in Oman
| Regulatory Authority |
The Directorate General of Pharmaceutical affairs and Drug Control |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
They accept all types
of classification |
| Medical Device Regulations |
Medical Device Guidelines
| Click Here
|
| Registration Process |
Requirements of High Risk Medical Devices /In
vitro diagnostic devices ( IVD) Registration in
Sultanate of Oman
| Click Here
|
| Registration Timeline |
3 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Arabic/English Language |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025