Laboratory Test Request Description

Saudi Arabia FDA Medical Devices Laboratory needed to test for Samples which are collected normally during inspection at the port of entry or at in establishment inspection or on healthcare facilities , or at local manufacture. Tests are required as follow:

1. Quality, safety, performance test of a medical device placed on the market which is the following medical device must be consider for the test on the lab:
 Anesthesia machine, Ventilator, Dialysis, Defibrillator, Cardiopulmonary system, IV Pump.
 Lens (Ultraviolet level protection for lens, Polarized lenses), frame, contact lens solution.

2. Verify the frequency rate (50/60HZ)
3. In vitro diagnostic test which include stability, analytical, performance test.
4. Accelerated ageing test
5. Material test
6. Sterility testing.


Number: 11-00011


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