| Regulatory Authority | Saudi Food and Drug Authority |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A, B, C, D |
| Medical Device Regulations | Rules and regulations | Click Here |
| Device Classification Guidelines |
Guidance on Requirements for Medical Device Listing and Marketing Authorization (Refer Page 110) | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | Class A devices requires 1 month and higher class devices may take 10 to 12 months |
| Technical Documentation Format |
Refer to Annex 3 and 4 | Click Here |
| Requirement of Authorized Representative | YES |
| Language Requirement | Labels must be in Arabic (for home use products) and English Language |
| Labeling Requirements |
It shall comply with the labelling requirements specified in the “Essential Principles of Safety and Performance” specified in Annex (1) and/or Annex (2) depending on the type of the device | Click Here |
| Clinical Trials Information |
Requirements for Clinical Trials of Medical Devices | Click Here |
| Certificate of Free Sale |
Saudi Food & Drug Authority (Medical Device Sector) issues SFSC upon request by a local Manufactures. The SFSC states that your medical device can be marketed legally within Saudi Arabian market. | Click Here |
| Post Market Surveillance |
Within (2 days) from the date of occurrence or awareness of adverse events or complaint, in case it represents a serious public health threat. Within (10 days) from the date of occurrence or awareness of adverse events or complaint, in case it represents a threat that may cause or contribute, directly or indirectly, in death or serious injury. Within (30 days) from the date of occurrence or awareness of adverse events or complaint, in case it represents any effect other than what mentioned in the aforementioned items. When the NCMDR contacts manufacturers, authorized representatives and healthcare providers for following up the investigation of incident, adverse event or complaint, they shall response within (5 days). | Click Here |
| Field Safety Corrective Action |
A. Manufacturer through its Authorized Representative (AR) or importer shall report to the SFDA any FSCA when the KSA is affected by filling the) Add New Device FSN( form via NCMDR website.
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| Advertising and Promotions |
Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices | Click Here |
| Additional Information | Class I Non-sterile/ Non-Measuring Low-Risk Medical Devices must secure a Medical Device National Registry (MDNR) Listing while other classes must secure Medical Device Marketing Authorization (MDMA). |