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Jordan

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Jordan

Medical Device Registration in Jordan

Ministry of Health:     

Ministry of Health, Jordan

Regulatory Authority:          

Jordanian Food and Drug Administration (JFDA)

Medical Device Regulation:          

Medical Devices Importation Regulations

EU MDR 2017/745

Good Practice Guide to Medical Supplies Manufacturing

Official Language:      

Arabic

Classification:    

Class I, IIa, IIb, III

Registration Process:

  • Determine the Device classification
  • Appoint an authorized representative (AR) in Jordan to submit an application.
  • Fill out the application form and submit all required documents
  • If approved, the applicant will receive a registration certificate
  • The applicant has the right to submit an objection to the MD committee within 30 working days from being notified of the committee’s decision.

Authorized Representative:          

Yes 

License Validity:               

4 years

Documents Required:          

  • Certificate of Free Sale (CFS)
  • Quality system certification
  • Declaration of conformity
  • Description of device and intended use
  • CE Certificate
  • Letter of Authorization
  • Original Catalogue
  • Samples of the outer pack, inner pack and insert leaflet (if available);
  • Finished product specifications and method of analysis of the medical Devices.
  • Technical File

Post-market surveillance:  

Adverse event report,

Serious public health threats – 2 day

Death or serious health deterioration – 10 days

Other serious incidents – 15 days

Legalized/Notarised Documents (if any)      

Free Sales Certificate

Applicable QMS:          

ISO 13485

Registration Timeline:         

Class I      – Approx. 4 months

Class IIa  – Approx. 4 months

Class IIb – Approx. 6-8 months

Class III – Approx. 8 months 

The approval process takes between four and eight months, depending on whether lab testing is required.

 

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