Medical Device Registration in Yemen

Ministry of Health

Ministry of public Health & Population Yemen

Regulatory Authority

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

Official Language

Arabic

Classification

Class I, IIa, IIb, III, and IV

Registration Process

• 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

Documents Required

• 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.

Applicable QMS

ISO 13485:2016

Registration Timeline

3-6 months

Authorized Representative

Yes

License Validity

5 years

Special Notes

All documentation may be submitted in English.