Regulatory Agency
The Food and Drug Administration (JFDA), under the Ministry of Health (MOH), regulates all medical devices in Jordan.
Medical Device Definition
A medical device in Jordan means Every device/tool/material or item used separately or engaged with others, including all programs needed for operating same, which the manufacturer prepares for human use to achieve the following:
- Diagnosis, prevention, supervision, treatment, or reduction of diseases.
- Diagnosis, supervision, reduction of or usage instead of any damage.
- Diagnosis, replacement, or amendment to the physiological situation.
- Planning pregnancy.
- Sterilization of medical devices, surfaces, and surgical kits.
- Providing information for a medical or diagnostic purpose through laboratory tests of samples taken from the human body.
This does not accomplish its clear mission from its usage in/on the human body through a pharmaceutical tool or in an immunological or photosynthesis way. Still, its mission could be achieved by using any of these devices, making it distinct from other drugs.
Medical Device Classification System
Classification |
Low Risk |
Examples |
Class I |
Low risk |
Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale |
Class IIa |
Low–moderate risk |
Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask |
Class IIb |
High- Moderate risk |
Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens |
Class III |
High risk |
HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker |