It is based on the SFDA’s team plan and visit schedule

Yes, it is mandatory

Food clearance conditions and requirements : Click Here

1.   King Khaled airport – Riyadh

2.   King Abdulaziz airport - Jeddah

3.   King Fahad Airport – Dammam 

4.   Prince Mohammed Bin Abdulaziz International Airport – Medina

5.   King Abdulaziz sea port - Dammam

6.   King Abdullah Sea port - Rabigh

7.   Jeddah Islamic sea port

8.   Dry port – Riyadh

9.   Al-Batha outlet - Al-Ahsaa

10.   King Fahd Causeway- Al Khobar

11.   Al- Khafji outlet

12.   Al-Hadethah outlet – Qurayyat

13.   Salwa outlet

1. Login with user name and password.
2. Choose update.
3. Confirm update.

1. Register an account through the link: https://mrmr.sfda.gov.sa
2. Fill-in personal data and choose the type of facility.
3. Activate your account via the link sent to the registered email,
4. Login with user name and password.
5. Send a request, after you fill out all required fields attaching all required documents.

SFDA represented by the medical devices sector requires obtaining prior approval before conducting any clinical study in accordance with the requirements mentioned in the 'Guideline for the Requirements of Clinical Studies for Medical Devices and Products (MDS - G20) and in compliance with the International Standard (ISO 14155) Concerning Good Clinical Practice.
The guidelines of the requirements for conducting clinical studies on medical devices can be referred to through the following links on the SFDA website:

- النسخة العربية:  https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20a.pdfG20)ar.pdf
- النسخة الإنجليزية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20e_0.pdf

if SFDA deems to  the necessity of conducting a study to evaluate the device, according to the frequency or severity of accidents, it may result in the addition of some conditions, which will inevitably be based on the methodology of risk analysis based on scientific foundations, and considering the best international practices.

Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon
becoming aware that adverse event, incident, a complaint has occurred, as follows:
− Not later than (2) working days from the date of awareness, if the adverse event, incident,
and complaint represent a serious public health threat.
− Not later than (10) working days from the date of awareness if the adverse event, incident,
complaint that results in an unanticipated death or unanticipated serious injury.
− Not later than (30) calendar days from the date of awareness for all adverse events, incidents,
complaints which are not associated with high risks.
− If SFDA initiate a report of adverse event, incident, complaint, the response shall be received
within (5) working days.