Saudi Arabia
- Regulatory Authority:
Saudi Food and Drug Authority (SFDA)
- Legislation:
Interim Order No.1-8-1429 of 2008
- Language of labeling and documentation:
English and Arabic
- Authorized Representative:
country resident
- Registration period:
5–6 months
A brief algorithm for registration of medical devices in Saudi Arabia:
02
Appointment of an Authorized Representative to manage device registration and communicate with SFDA on behalf of the manufacturer
06