Jordan Medical Device Classification Rules: Four Classes with Is and Im Sub-Classes

1. Key takeaways

Jordan applies a risk-based system of four basic classes (I, IIa, IIb, III) that recognises two Class I sub-classes (Is and Im), corresponding to the EU classification model. GRZAN’s classification conclusion is straightforward: for products already holding CE certificates, the EU classification is usually accepted directly in Jordan; for products already holding FDA approval, the United States classification can be mapped onto the Jordanian system.

The second conclusion is that classification is the first decision variable of Jordanian registration. It determines the depth of documentation, whether a clinical evaluation report is needed, whether local sample testing may be triggered, and — since 9 October 2025 — whether the product falls within the mandatory category that must complete registration before importation.

The third conclusion is that a classification error costs a restart. Under-classification leads to supplementary submissions during technical review; over-classification needlessly increases the documentary burden and the timeline without adding any value.

• Four classes I, IIa, IIb and III, with Is and Im sub-classes, mapped to the EU model.
• Classification governs dossier depth, clinical evaluation, local testing and, since October 2025, importability.
• Existing CE or FDA classifications serve as anchors that are usually accepted in Jordan.
• Errors in either direction carry real cost: restart, delay or wasted effort.

Classification is where the international and local dimensions of Jordanian regulation meet. The classes themselves are internationally familiar, so evidence built for other markets travels well, yet the consequences of a class — the documents, the testing and the importability rules — are decided locally. Companies should treat the classification file as a living document: drafted once against the four dimensions, then re-examined whenever the product, its intended use or the applicable circulars change.

2. Legal basis

The classification system rests on the following instruments.

Provision numbers are subject to the Arabic original texts issued in the Jordanian Official Gazette and by JFDA.

3. Expert insights

Insight 1: the determination dimensions follow the internationally common rules. Jordan’s classification factors are intended use, degree of invasiveness, duration of contact with the patient, and whether the device is active. These correspond to the four core variables of the EU classification rules, so companies can reuse their existing classification rationale documents rather than writing new ones from scratch. The reuse is not only convenient; it also keeps the classification story consistent across markets, so that a question raised in Jordan can be answered with the same rationale already accepted elsewhere.

Insight 2: the Is and Im sub-classes bring additional documents. Is applies to Class I devices supplied sterile, and Im applies to Class I devices with a measuring function. Compared with ordinary Class I devices, both sub-classes may trigger additional requirements: sterile devices need sterilisation validation documentation, and measuring devices need metrological performance documentation. When GRZAN compiles a Class I dossier, it first confirms whether the product falls into either sub-class.

Insight 3: Class IIb holds a special position after 2025. Under JFDA Circular No. 54863/1/5 of 9 October 2025, Class IIb devices may not be imported before registration is completed and JFDA approval is obtained, with implantable devices exempted. This rule pushes Class IIb from a “procedural requirement” to a “hard customs gate”, and the commercial consequences of classification determination are thereby magnified.

Insight 4: the classification examples allow cross-checking. Cholesterol/uric acid testing systems, surgical instruments, bandages, surgical camera systems, electric operating tables and patient scales fall in Class I; pregnancy self-tests, electric hospital beds, surgical lights and surgical masks in Class IIa; blood glucose self-tests, ECG machines, X-ray machines, syringes, condoms and contact lenses in Class IIb; HIV blood donor screening, stents, intraocular lenses, defibrillators and pacemakers in Class III. Companies can self-check against these examples first, then return to the rules for verification.

4. Practical recommendations

• Issue a written classification rationale. Do not treat classification as a form-filling item; produce a document covering the four dimensions of intended use, invasiveness, contact duration and active nature, and submit it with the dossier.
• Use the existing CE or FDA classification as an anchor. Citing the classification conclusions of a notified body or FDA directly can markedly reduce the probability of JFDA queries.
• Reschedule project plans for products falling into Class IIb. Since the 2025 circular took effect, the completion date of a IIb registration directly determines when imports become possible; move the registration lead-in from “before shipment” to the commercial negotiation period.
• Record the classification rationale, the anchoring CE or FDA conclusion and the applicable circulars in one place, so that the basis of every registration decision remains auditable.

5. Verification checklist

• □ Issue a written classification rationale along the four dimensions of intended use, invasiveness, contact duration and active nature
• □ Check whether the product falls into the Is (sterile) or Im (measuring) sub-class and prepare the corresponding additional documents
• □ Cross-check against the existing CE or FDA classification conclusions
• □ If classified as Class IIb, confirm the applicability of Circular No. 54863/1/5 (9 October 2025) and the implantable exemption judgement
• □ If classified as Class III, confirm whether an EC full quality assurance system and a design examination declaration of conformity are required
• □ Re-verify the cited provision numbers against the Arabic original texts of the Official Gazette

Regulatory information verified as of 29 October 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 Jordan Food and Drug Administration (JFDA) registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com