Jordan medical device registration timeline
Source-linked clocksJordan Food and Drug Administration (JFDA) review clocks and end-to-end planning ranges, using the MDD-derived فئات Class I, IIa, IIb and III plus an active-implant فئة classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I and Class IIa outside the Annex 7 list(No registration — import permission from the Director General only) Art. 5(ي) is explicit that medical supplies in Class I and Class II a are not registered, except the items listed in Annex 7, which go to the Committee on the Annex 1 conditions | 0 days | 0 days | — | Verified |
| Class IIb and Class III(Registration by the Medical Devices and Supplies Committee) Art. 3(b)(3): the Committee must decide within a period not exceeding 45 working days from the date the Directorate receives the application with its documents complete | 45 working days | 4-8 months | — | Verified |
| Any class listed in Annex 7, in pharmaceutical form, drug-containing, a surgical suture, a disinfectant or sterilant, or carrying a medical claim(Registration by the Medical Devices and Supplies Committee) Art. 5(أ) pulls this group into registration whatever its class, on the Annexes 1, 4 and 5 conditions, and Art. 3(b)(3) applies the same 45-working-day committee decision to it | 45 working days | 4-8 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesJordan Medical Device Registration Process
Step-by-step JFDA registration process. Total estimated timeline: 0 days.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by JFDA. Appoint a Authorized person (الشخص المفوض) of a Jordanian importer.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to JFDA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksJFDA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. JFDA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, JFDA issues Jordan market authorization certificate.
- Authorized person (الشخص المفوض) approved by the Directorate, holding at least a diploma, who files and follows every transaction
- Valid commercial register and a professions licence for the importer, or one expired by no more than three months
- Locally manufactured supplies are registered only after their manufacturing site and production lines are approved against the JFDA good manufacturing practice guide (Art. 5(ط))
- Import of used or refurbished devices is prohibited, except for exhibition and re-export without circulation in the Jordanian market (Art. 5(ز))
- The Committee meets four times a month, and its decisions are taken unanimously or by a majority of those present (Art. 3(a))
- Appeal: 30 days from notification of a decision to the Objections Committee constituted under the Law (Art. 13)
- The Art. 5(ج) and 5(د) import permissions remain a separate gate for every consignment, registered or not, and carry no published period
Reviewed 2026-08-30. End-to-end totals remain planning estimates.