Saudi Arabia Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Saudi Arabia.
Related services for Saudi Arabia:
- Saudi Arabia (KSA) Authorized Representative with the SFDA
- SFDA medical device registration in Saudi Arabia
Related resources:
- Medical Device Registration in Saudi Arabia
- Saudi Arabia Approval Process for Medical Devices
- Saudi Food & Drug Authority
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Medical Devices Interim Regulation | 4/16/1439 | 12/2017 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Guidance on Medical Device Field Safety Corrective Actions | MDS-G22 | English | |
| Log in | Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices | MDS-G34 | English | |
| Log in | Guidance on Innovative Medical Devices | MDS-G43 | English | |
| Log in | Guidance on Requirements for Reporting of Incident and Adverse Event of Medical Devices | MDS-G39 | 2019 | English |
| Log in | Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices | MDS-G41 | 2019 | English |
| Log in | Guidance on Medical Devices Classification | MDS-G42 | 2019 | English |
| Log in | Guidance on Labeling Requirements for Medical Device | MDS-G10 | 2015 | English |
| Log in | Guidance on Medical Devices Grouping | MDS-G7 | 2018 | English |
| Log in | Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives | MDS-G45 | 2020 | English |
| Log in | Guidance on Requirements for Medical Device Listing and Marketing Authorization | MDS - G5 | 2019 | English |
