Kingdom of Bahrain
- Regulatory Authority:
National Health Regulatory Body under the Ministry of Health of the Kingdom of Bahrain
- Language of labeling and documentation:
Arabic, English
- Registration period:
2–3 months
If medical device has marketing authorization in Saudi Arabia (SFDA)
4–6 months
If medical device HAS NO marketing authorization Saudi Arabia (SFDA)
- License validity period:
3 years
If medical device has marketing authorization in Saudi Arabia (SFDA):
Depends on the quality certificate
If medical device HAS NO marketing authorization in Saudi Arabia (SFDA)
- Authorized Representative:
country resident
- Legislations:
Medical Device Regulation (MDR) Ver 2.0