Saudi Authorized Representative with the SFDA

 

Saudi Medical Device Authorized Representative

Bio-Standards is the first independent Authorized Representative and Medical Devices Regulatory Service provider in Saudi Arabia, Bio-Standards is a KSA licensed Authorized Representative and is operated by a highly experienced team specializing in SFDA regulations & Systems.

According to Saudi Food & Drug regulations, Medical Device manufacturers who are not based in the kingdom of Saudi Arabia (KSA) must appoint a local Authorized Representative. The Authorized Representative act as a liaison between you and the kingdom of Saudi Arabia Food & Drug Authority(SFDA), as specified by the Medical Devices Interim Regulation(MDIR), Decree No. 1-8-1429/2008 . The Authorized Representative assumes regulatory representation for the products in the KSA Market and is responsible for submitting registration of your Device with the SFDA.

Medical Device Registration and regulations in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA, and registration in one of these markets is mandatory in order to register in Saudi Arabia.

 

We are your strongest link in Saudi Arabia as Dealing with Saudi Food & Drugs Authority (SFDA), Compile Medical Device Marketing Authorization (MDMA), Post Market Surveillance, Inform SFDA of incidents outside KSA, Cooperate with the distributors and importers.

 

Bio-Standards as your Saudi Medical Device Authorized Representative Will:

  • Submit the Authorized Representation registrations with the Saudi FDA.
  • Administer the Authorized Representative registration fees.
  • Submit your MDMA application (Medical Device Marketing Authorization ) with the SFDA.
  • Administer MDMA application (Medical Device Marketing Authorization ) fees.
  • Notify the SFDA of any Changes to the product(s) .
  • Assist in adverse event reporting to the SFDA , in close liaison with you and distributors.
  • Assist in Device Feield Safety Corrective Actions (recalls) .
  • Assist in providing marketing/advertising materials to the SFDA for approval.
  • Be available at all times to interact between the manufacturer and the SFDA.