Medical Device Marketing Authorization (MDMA) registration with the SFDA is required for Medical Devices and In-Vitro Medical Devices (IVD). The Medical Device registration with the SFDA can be grouped into MDMA applications as per the bundling criteria set out by the SFDA.
We, Bio-standards, will provide support for the registration of the medical devices with the SFDA and will also be responsible for reviewing the documents to ensure that they comply with the Saudi Food and Drug Authority’s (SFDA) requirements, submitting the documents on the SFDA’s database and communicating with the SFDA on behalf of the manufacture. Please note that a soft copy of the documents in the English language is required. Documents in the Arabic language can only be requested for home-use medical devices that can be used by a lay person.
Once the application has passed through the review stages and is found to be complying with the requirements, then SFDA approves the application and a Medical Device Marketing Authorization MDMA certificate is issued.
- Renewal application can be initiated 3 months (90 days) prior to the expiry of the current MDMA license. New product is NOT allowed to be added
- Update application (Minor/ Major) can be initiated any time to notify SFDA of any changes in the existing documentation or to add models/products to the existing application.
- New MDMA application takes approximately 3 to 4 months starting from the date of submission of the application to the SFDA.
- Renewal/Update MDMA application takes approximately 6 to 8 weeks starting from the date of submission of the application to the SFDA.
- The validity of the MDMA certificate is 3 years for the registration completed through the technical file assessment (TFA) rout.
- The validity of MDMA certificate for medium and high-risk medical devices is up to a maximum of 3 years, taking into account the validity of the conformity certificates issued by the recognized international bodies if it is less than three years.
- Validity of the renewal MDMA certificate is counted from the day of expiry of the old certificate.
| The Basis of the Application for SFDA Marketing Authorization | Evaluation Fee |
| All Class I / A General IVD (Other) / Exempt IVD (TGA) | SAR 15,000 |
| All Class II / Class IIa / B Self-test IVD / Listable IVD | SAR 19,000 |
| All Class IIb / Class III (CA,PAL) / C Annex II List B (IVD) | SAR 21,000 |
| All Other Class III / Class IV /AIMD / D Annex II List A (IVD) / Registrable IVD | SAR 23,000 |
| Update and Renew (Minor Modifications) | SAR 1,100 |
| Renew (Update DE Certificate) | SAR 1,500 |
| Update and Renew (Major Modifications) | SAR 5,000 |