Medical Device Registration Saudi Arabia
Ministry of Health:
Regulatory Authority:
Saudi Food & Drug Authority (SFDA)
Medical Device Regulation:
Medical Devices Interim Regulation
Official Language:
Arabic
Classification:
Class A, B, C & D
Medical Device Registration in Saudi Arabia:
- Determine the device classification
- Appoint an Authorized Representative
- Prepare the application form and required documentation.
- Submit the information for registration purposes
- Provide the medical device listing information to the Medical Device National Registry (MDNR)
- Submit Medical Device Marketing Authorization (MDMA)
- Once approved, the device can be marketed
Documents Required:
- Application Form
- Authorized Representative
- MDNR Listing
- Technical File
- Conformity Assessment Report
- Medical Device Market Authorization Certificate
Post-market surveillance:
Adverse events to be reported to the SFA
Applicable QMS:
ISO 13485
Registration Timeline:
Class A – 1 month
Class B – 2-6 months
Class C – 4-8 months
Class D – 6-12 months
Authorized Representative:
Yes
License Validity:
3 years