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:

Diagnosis, prevention, supervision, treatment or reduction of diseases.
Diagnosis , supervision, reduction of / usage instead of any damage.
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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