Medical Device Registration in
Ministry of Health:
Medical Device Regulation:
EU MDR 2017/745
Class I, IIa, IIb, III
- 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.
- 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
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
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.