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 |
|---|---|---|---|
| National Provisions and Requirements for Medical Devices | en | SA-001 | 09/2014 |
| The Interim Regulatory Scheme | en | 1-8-1429 | 12/2008 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Barcode FAQ | en | FAQ | 08/2015 |
| Guidance for Local Manufacturers | en | MDS - G2 | 04/2009 |
| Guidance for Medical Device Authorised Representatives | en | MDS - G3 | 04/2009 |
| Guidance for Medical Devices Importers and Distributors | en | MDS - G1 | 04/2009 |
| Guidance for Overseas Manufacturers | en | MDS - G4 | 04/2009 |
| Guidance on Marketing Authorization Procedures | en | MDS - G5 | 04/2009 |
| Guidance on Medical Devices Bundling/Grouping Criteria | en | MDS - G7 | 04/2009 |
| Guidance on Post-Marketing Surveilance | en | MDS - G6 | 04/2009 |
| Implementing Rule On Licensing Of Authorised Representatives | en | MDS - IR5 v3 | 02/2011 |
| Implementing Rule On Marketing Authorisation | en | MDS – IR 6 v3 | 04/2009 |
| Implementing Rule On Post- Marketing Surveillance | en | MDS – IR 7 v1 | 01/2010 |
| Implementing Rule on Designation and Oversight of Conformity Assessment Bodies | en | MDS - IR1 v2 | 01/2010 |
| Implementing Rule on Establishment Licensing | en | MDS - IR4 v4 | 02/2011 |
| Implementing Rule on Establishment Registration | en | MDS - IR2 v3 | 04/2010 |
| Implementing Rule on Medical Devices Listing | en | MDS - IR3 v4 | 04/2010 |
| Implementing Rule on Safeguard Procedures | en | MDS-IR8 | 01/2010 |
Forms and Applications
| Document | Language | Number | Published |
|---|---|---|---|
| Marketing Authorization Application form | en | for use with MDS IR6 | 01/2010 |
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 | 09/2014 |
