| Regulatory Authority | Ministry of Health and Prevention |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I,II,III,IV |
| Registration Process | Registration of a Medical Equipment Registration of a Medical Equipment Infographic | Click Here |
| Registration Timeline | 45 working days |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English Language |
| Adverse Event Reporting Form | Download |
| Additional Information | Marketing Authorization Holder companies and product manufacturing sites must be registered in MOHAP prior to the registration of their products. |