Saudi Arabia Medical Device Regulations
All documents listed below were published by Saudi Food and Drug Authority (SFDA) and are in PDF format.
Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Medical Devices Interim Regulation | en | 4/16/1439 | 12/2017 |
| National Provisions and Requirements for Medical Devices | en | SA-001 | 10/2018 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Barcode FAQ | en | FAQ | 08/2015 |
| Guidance for Local Manufacturers | en | MDS - G2 | 01/2013 |
| Guidance for Medical Device Authorised Representatives | en | MDS - G3 | 01/2013 |
| Guidance for Medical Devices Importers and Distributors | en | MDS - G1 | 01/2013 |
| Guidance for Overseas Manufacturers | en | MDS - G4 | 01/2013 |
| Guidance on Marketing Authorization Procedures | en | MDS - G5 | 01/2013 |
| Guidance on Medical Devices Bundling/Grouping Criteria | en | MDS - G7 | 06/2018 |
| Guidance on Post-Marketing Surveilance | en | MDS - G6 | 04/2009 |
| Implementing Rule On Licensing Of Authorized Representatives | en | MDS - IR5 v4 | 07/2018 |
| Implementing Rule On Marketing Authorization | en | MDS – IR 6 v4 | 07/2018 |
| Implementing Rule On Post-Marketing Surveillance | en | MDS – IR 7 v2 | 07/2018 |
| Implementing Rule on Designation and Oversight of Conformity Assessment Bodies | en | MDS - IR1 v2 | 01/2010 |
| Implementing Rule on Establishment Licensing | en | MDS - IR4 v5 | 07/2018 |
| Implementing Rule on Establishment Registration | en | MDS - IR2 v4 | 07/2018 |
| Implementing Rule on Medical Devices Listing | en | MDS - IR3 v5 | 07/2018 |
| Implementing Rule on Safeguard Procedures | en | MDS-IR8 v2 | 07/2018 |
Additional Information
| Document | Language | Number | Published |
|---|---|---|---|
| Authorised Representative application fees and review times | en | MDS - AN005 | 12/2010 |
| Establishment licensing application fees and review times | en | MDS - AN006 | 12/2010 |
| Marketing Authorization application fees and review times | en | 2/13/MDS-AN012 | 03/2019 |