Jordan Medical Device Regulations

Agency
All medical devices are regulated by the Food and Drug Administration (JFDA) under the Ministry of Health (MOH).
Medical Device Definition
Every device / tool / material / or item used separately or engaged with other including all programs needed for operating same which are prepared by the manufacturer for human use for the purpose of achieving any of following:
  1. Diagnosis, prevention, supervision, treatment or reduction of diseases.
  2. Diagnosis , supervision, reduction of / usage instead of any damage.
  3. Diagnosis, replacement / or amendment to the physiological situation.
Medical Devices Importation Regulations, Art. 2.
Classification of Medical Device
International Classification Examples Risk Level
I Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale Low
IIa Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask Low - Moderate
IIb Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens High - Moderate
III HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker High
Premarket Approval Process
Class I Class IIa Class IIb Class III
Appoint an authorized representative (AR) in Jordan to submit application.
Fill out application form and submit all required documents (listed below).
If approved, applicant will receive a registration certificate
Applicant has the right to submit an objection to the MD committee within 30 working days from being notified of committee's decision.
List of Required Documents
  • CFS
  • Quality system certification
  • Declaration of conformity
  • Description of device and intended use
  • Clinical and preclinical data
Additional Information
Validity Four years unless other certification expires first.
Postmarket Surveillance Some controls in place.
Timeline Low risk: approx. 4 months. High risk: approx. 8 months.
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