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Yemen

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Yemen

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.

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