Jordan Circular 54863/1/5: Class IIb Import Requires JFDA Registration

1. Key takeaways

On October 9, 2025, the Jordan Food and Drug Administration issued Circular No. 54863/1/5: medical devices classified as Class IIb may not be imported into Jordan until the registration procedure has been completed and the JFDA has granted approval. The GRZAN conclusion is that this is the most significant change in Jordanian device regulation in the past two years: it rewrites registration from a “pre-market procedure” into a “precondition for customs clearance”, so that the question of whether a product can enter the country is decided at the border, on the strength of the certificate alone.

The second takeaway: implantable medical devices are not covered by the decision and remain exempt. This exception is the first sieve for determining whether a product is affected, and it must be checked before any scheduling or shipping decision is made on the basis of the circular.

The third takeaway: the stated legislative purpose of the circular is to improve quality assurance and patient safety for medical devices supplied to the Jordanian market. On this basis GRZAN judges that similar tightening measures may extend to other risk classes, which means companies outside Class IIb should not treat this as an isolated event.

2. Legal basis

The circular’s number and date are as published by the JFDA; clause numbers are subject to the Arabic originals in the Jordanian Official Gazette; the amounts are official fees listed in the JFDA fee schedule.

3. Expert insights

Insight one: this is the first differentiated lever GRZAN has selected for the Jordanian market. The substance of the circular is to elevate “registration first” from a procedural convention to a mandatory condition. Before it, companies had practical room to manoeuvre on the sequencing of importation and registration; after it, importation of Class IIb products is hard-conditioned on registration approval, and the sequencing room that used to exist is gone.

Insight two: the exemption for implantables reflects the priority given to clinical access. Implantable devices generally fall into Class III, whose registration pathway is already the most demanding. The exemption avoids supply interruptions for clinically needed implantable devices caused by customs restrictions, striking a balance between quality assurance and patient access on the part of the authority.

Insight three: the range of affected product lines is clear. Under Jordan’s classification examples, Class IIb covers self-testing blood glucose meters, electrocardiographs, X-ray machines, syringes, condoms and contact lenses. All of these are categories with substantial Chinese export volumes, so the affected scope is broad, and many exporters will need to revisit their Jordanian pipeline rather than a single product.

Insight four: import invoice approval (10 JOD) is the enforcement point of the new policy. The circular is executed at the per-shipment import approval stage — a Class IIb product without a valid registration certificate cannot have its import invoice finalised. This makes the new policy operational rather than a statement of principle: the check happens on every shipment, not occasionally.

Insight five: the immediate enforceability of the circular derives from JFDA institutional autonomy. Law No. 41 of 2008 grants the JFDA financial and administrative autonomy, and circulars carry immediate effect in its regulatory practice. Compliance tracking must therefore treat the circular as the smallest unit of analysis, since a single circular can change import conditions without any transition period.

Insight six: project scheduling logic has been rewritten. For Class IIb products, the completion time of registration shifts from “affecting time to market” to “determining when importation is possible”. Entry arrangements for samples, clinical trial units and exhibition items all need to be redesigned, because the old assumption that goods can land while paperwork continues no longer holds for this class.

4. Practical recommendations

First, immediately compile the list of Class IIb products sold in Jordan and verify registration status item by item. For products without a registration certificate, suspend commercial shipment arrangements until the certificate is in hand.

Second, verify applicability of the implantable exemption. Confirm whether the product falls into the implantable category; non-implantable Class IIb products do not benefit from the exemption.

Third, move registration forward into the commercial negotiation stage. Registration of Class IIb products should begin during channel negotiations, not after orders are confirmed, so that the certificate never becomes the bottleneck of a signed contract.

Fourth, redesign the entry arrangements for samples and exhibition items. Before registration is completed, the entry routes for Class IIb samples, clinical trial units and exhibition samples need separate planning.

Fifth, establish a circular-level tracking mechanism. Review JFDA circulars quarterly and watch whether similar requirements extend to other risk classes.

5. Verification checklist

• □ The list of Class IIb products sold in Jordan is compiled and registration status verified item by item
• □ The scope of Circular No. 54863/1/5 (2025-10-09) and the implantable exemption are confirmed
• □ Commercial shipment arrangements for Class IIb products without completed registration are suspended
• □ Registration of Class IIb products is moved forward into the commercial negotiation stage
• □ Entry arrangements for samples, clinical trial units and exhibition items are replanned
• □ A quarterly mechanism for reviewing JFDA circulars is in place
• □ The circular’s content is verified against JFDA official announcements and the Arabic originals

Regulatory information verified as of October 29, 2026.

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 manages adverse event reporting and recall coordination with the JFDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com