Medical Device Registration in
Ministry of Health
Ministry of public Health & Population Yemen
Supreme Board of Drugs and Medical Appliances or SBDMA
Medical Device Regulation
Republican Decree No. 44/1971 on the Establishment of the Supreme Board of Drugs and Medical Appliances
Class I, IIa, IIb, III, and IV
- Determine the device classification
- Appoint an Authorized Agent.
- The Appointed Agent must register with the Ministry of Industry and Trade.
- The agent must register the manufacturer with the MPHP, which regulates Medical Devices through the SBDMA.
- The agent must begin the registration of the product itself with the Yemenite authorities.
- Once approved, the device can be marketed in Yemen
- Technical Documentation
- GMP certificate or ISO 13485
- FSC (Free Sale Certificate)
- A CE Mark is not required but can ease the registration process.
- In the case of invasive Devices, either USA FDA approval or certification from the Gulf
- Cooperation Council (GCC); in case that the registration in any of these markets has not yet been obtained, an on-site inspection must take place at the manufacturer’s expense.
All documentation may be submitted in English.