Objectives:

The Compliance and Enforcement Executive Management objectives are to insure that importers, distributors, authorized representative of foreign and local manufacturers of Medical Devices, and all Medical Devices and their accessories they supply to the KSA market are in compliance with SFDA- Medical Devices rules and regulations, as well as insuring safety, effectiveness and quality of medical devices.


Responsibilities:

Inspection Department:

  1. Inspection of medical devices and IVDs establishments.
  2. Inspection of medical devices and IVDs the Saudi market.
  3. Assure the compliance of medical devices and IVDs on the Saudi market with SFDA- Medical Devices rules and regulations.

Compliance Assessment Department:

  1. Assess evidence and documents gathered throughout inspection process
  2. Classify non-compliances and determine action needed in coordination with other medical devices sector departments.
  3. Conduct follow-up visit on the establishments
  4. Ensure resolution

Enforcement Department:

Implement enforcement actions against establishments in violation of the SFDA- Medical Devices regulation.

Port of Entry Department:

  1. Ensure the submitted documents complies with relevant provisions of SFDA.
  2. Ensure the importers are registered in (MDNR).
  3. Ensure the importers have obtained (MDEL) license .
  4. Ensure the imported medical device has obtained ( MDMA).
  5. Ensure there is no recall on the imported Medical Devices.
  6. Perform a random Sampling of imported MDs for Inspection.