• White Page Details
For Free Consultation
Mobile No- +971556008944

Jordan Medical Device Regulations


Regulatory Authority

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.

 

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.

Post market Surveillance

Some controls in place.

Timeline

Low risk: approx. 4 months. High risk: approx. 8 months.