Jordan Medical Device Regulations

Regulatory Agency

The Food and Drug Administration (JFDA), under the Ministry of Health (MOH), regulates all medical devices in Jordan.

Medical Device Definition

Medical Device: every device, means, material, tool, item, reagent, and laboratory standard, whether used alone or in combination with others, including the software necessary for its use, and prepared by the manufacturer for use by humans to achieve any of the following purposes, and which does not achieve the desired goal of its use in/on a person body by pharmacological, immunological, or nutritional means, but his work can be helped by these means, and this is what distinguishes him from medicine.
1. Diagnosis, prevention, monitoring, treatment, or mitigation of diseases.
2. Diagnosis, monitoring, mitigation, and/or compensation for any injury or disability.
3. Exposing, compensating, or adjusting the anatomical position.
4. Pregnancy regulation.
5. Sterilization of medical devices, surfaces, and surgical kits.
6. Providing information for a medical or diagnostic purpose through laboratory tests of samples taken from the human body

Medical Device Classification System

Classification	Low Risk	Examples
Class I, Class Is, Class Im	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

Regulatory Approval Process

Classification	Approval process
Class I	Appoint an authorized representative (AR) in Jordan to submit the application. Request an electronic appointment through the link: http://application.jfda.jo/Cosmo Applicant shall pay fees needed Fill out the application form and submit all required documents. If approved, the applicant will receive a registration certificate with a 10-year validity.
Class IIa
Class IIb
Class III

Additional Information

Approval timeline	2-4 months approximate
License validity period	10 years
Fees	$142, In case the Medical Device need analysis additional fees to be paid as: $211

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