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Jordan Medical Device Regulations

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
Approval Process
Classification Approval procedure
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 5 years validity.
Class IIa
Class IIb
Class III
Additional Information
Approval timeline 1-2 months approximate
License validity period 5 years
Fees $141, In case the Medical Device need analysis additional fees to be paid as: $71
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