Import Invoice Approval: The Permit Process for Every Shipment

1. Key takeaways

Jordan applies approval on every import shipment to medical devices: each commercial import must apply to the JFDA for import invoice approval, against a fee of 10 JOD per invoice. GRZAN’s conclusion is that the registration certificate answers whether the product may enter Jordan at all, while the import invoice approval answers whether this specific batch may enter — the two are serial steps, not parallel ones. In other words, holding a certificate does not by itself open the market; the certificate only makes each subsequent shipment eligible for approval.

• Second conclusion: from October 9, 2025, Class IIb devices may not be imported until their registration has been completed and approved by the JFDA (implantable devices are exempt). This new policy tightens the precondition of import invoice approval to a completed registration. The approval is administrative in nature, but its preconditions are substantive.
• Third conclusion: the import approval step requires an institutional representative or an authorised representative to be present. The JFDA import approval procedure published on the Jordan Trade Portal provides that a representative must be present when import documents are processed, which means that every single batch requires the actual involvement of the AR.

2. Legal basis

The import invoice approval requirement and its preconditions rest on the following instruments. The circular of October 2025 sits at the top of the hierarchy for Class IIb products, so it is listed first.

Provision locations follow the Jordan Trade Portal and JFDA announcements; the amounts are the official fees listed in the JFDA fee schedule.

3. Expert insights

Insight 1: the 2025 circular changed the precondition structure of import approval. Before it took effect, the relationship between import and registration retained a degree of practical elasticity. After the circular, imports of Class IIb products are hard-conditioned on a registration approved by the JFDA. GRZAN reads this change as the marker of Jordan’s shift from an approach that encouraged registration to one that makes registration mandatory. For companies with Class IIb portfolios, the circular therefore sets the true market entry date: not the day of application, but the day of approval.

Insight 2: the exemption for implantable devices reflects considerations of clinical urgency. The circular states expressly that the decision does not apply to implantable medical devices, which remain exempt. This arrangement prevents implantable devices from suffering supply interruption caused by customs restrictions, and represents the JFDA’s balance between quality assurance and clinical access. The exemption keeps time-critical implants flowing for patients and removes one approval step for that category.

Insight 3: the legislative purpose of the circular is quality assurance and patient safety. The JFDA explains in the circular that its purpose is to improve the quality assurance and patient safety of medical devices supplied to the Jordanian market. On this basis, companies can anticipate that similar tightening measures may be extended to other risk classes. The stated purpose also explains the direction of travel: measures justified by patient safety are the easiest for a regulator to extend.

Insight 4: approval per batch sustains a continuous dependence on the AR. The fee of 10 JOD per batch is small, but every batch requires the AR to commit manpower and to be present in person. This institutional design means that a one-time registration cannot free the manufacturer from its dependence on the AR. Each shipment is, in effect, a small joint operation between the manufacturer and the AR.

Insight 5: sterilizers, disinfectants and filler injections carry separate record-keeping duties on import. The JFDA requires the relevant importers to retain, for each imported batch, the import invoice and the sales list, stating the purchasers, so as to ensure that the products are used only by authorised institutions. The record-keeping duty turns each sale into a documented, auditable event.

4. Practical recommendations

• Manage import approval as a standalone operational process. For every batch, schedule the invoice, the fee payment and the presence handling as one workflow. The process should name who prepares, who pays and who appears.
• Gate the import plan for Class IIb products on a completed registration. Do not arrange commercial shipments before the registration has been approved, so as to avoid goods being held at port. The registration milestone, not the sales forecast, should drive the shipping calendar.
• Check the applicability of the exemption for implantable products. Confirm whether the product falls within the implantable category; the exemption does not apply to non-implantable Class IIb products. The classification of each stock-keeping unit should be recorded before shipments are planned.
• Reserve time for the AR’s presence handling. Approval per batch means the AR’s responsiveness directly affects clearance speed, so response deadlines should be agreed in the agreement. Clearance speed is a commercial variable, not only a regulatory one.

5. Verification checklist

• □ Confirm that the products to be imported have completed JFDA registration and hold a registration certificate
• □ Check whether Class IIb products satisfy the registration precondition of circular No. 54863/1/5 (2025-10-09)
• □ Confirm whether implantable products qualify for the exemption
• □ Reserve the 10 JOD fee for the import invoice approval of every batch
• □ Confirm that the AR’s representative can be present to process the import documents
• □ A per-batch retention mechanism for sales lists is in place for sterilizers, disinfectants and filler injections
• □ Re-verify the import approval procedure against the Jordan Trade Portal and JFDA announcements

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Jordanian market. Our team coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com