JFDA Directorate of Medical Devices and Supplies: The Actual Review Authority in Jordan

1. Key takeaways

The actual review body for medical device registration in Jordan is the Directorate of Medical Devices and Supplies under JFDA. In all of GRZAN’s Jordan project communications, this directorate is treated as the sole technical window; any attempt to communicate around it produces no procedural effect.

The second conclusion concerns the institutional history: the directorate was upgraded to an independent Directorate in 2012. Before that, it had belonged since 2006 to the registration division of the Drug Administration, and was later elevated to a Section within that administration. This history shows that Jordanian device regulation grew out of the drug regulatory system; its review mindset, document format expectations and deficiency-handling habits all carry visible traces of drug review practice.

The third conclusion is that the directorate regulates both “devices” and “supplies”. Companies often assume that supplies are regulated loosely; in reality supplies are managed at the same level as devices within the same directorate, and controls such as import invoice approval and batch testing apply to supplies in the same way.

• The Directorate of Medical Devices and Supplies under JFDA is the only technical review window for device registration.
• The directorate became an independent Directorate in 2012, having grown out of the drug registration system since 2006.
• Devices and supplies are regulated side by side; supplies do not enjoy lighter control.
• Review practice retains drug-style preferences for specifications, analytical methods, certificates of analysis and stability data.

The practical meaning for companies is that the working style of the directorate must be anticipated rather than discovered. A reviewer trained in the drug tradition asks for substance behind each claim: a specification is backed by a method, a method by validation, a batch by a certificate of analysis. Preparing the dossier in that spirit, before the first query arrives, shortens the review and reduces the number of deficiency rounds that would otherwise stretch the timeline.

2. Legal basis

The instruments below define the directorate’s mandate and the import conditions it applies.

Provision numbers are subject to the Arabic original texts of the Jordanian Official Gazette; the institutional history is based on JFDA public materials.

3. Expert insights

Insight 1: the drug-review gene shapes document preferences. Because device regulation emerged from the drug system, Jordan shows a higher acceptance for drug-style documents such as finished product specifications, analytical methods, certificates of analysis (CoA) and stability data than for purely engineering-style documents. When GRZAN compiles dossiers for IVDs and reagent-bearing products, the materials are deliberately organised according to these preferences to reduce back-and-forth exchanges. A dossier built this way passes screening with fewer queries, because each claim already carries its own evidence trail.

Insight 2: the importation directives expressly cover sterilizers and detergents. The formal title of the directive is itself “Medical Devices Importation Directives Including Sterilizers & Detergents”. This means hospital disinfection products and sterilants used for devices enter Jordan through the device channel, not the chemical or cosmetics channel. A company that submits through the cosmetics route will be returned at formal screening. The channel also determines who inspects the product, which documents accompany each shipment, and how a query about a disinfection claim is answered; discovering the correct channel after a refusal means re-compiling the file under a different legal basis.

Insight 3: laser devices carry a separate front-end approval. JFDA has made clear that import invoices for various laser devices cannot be settled without a no-objection position from the Directorate of Professions and Institutions Licensing under the Ministry of Health, ensuring that use is confined to licensed beauty establishments. This is a cross-departmental front-end gate specific to certain devices, and it is a step that is very easy to trip over in practice. Planning the front-end approval early keeps the shipping calendar intact, because the no-objection position is obtained in parallel with dossier preparation instead of after it.

4. Practical recommendations

• Anchor all technical communication to the Directorate of Medical Devices and Supplies. The AR’s contact person should be able to reach the directorate window directly; the more intermediary layers there are, the slower deficiency responses become.
• For laser and filler-injection products, obtain the cross-departmental position before arranging shipment. A missing front-end step will directly stall import invoice approval.
• Do not lower the documentary standard for supplies. JFDA has set explicit requirements for retaining import invoices and sales records for sterilants, detergents and injection filler products.
• Maintain a written log of every technical exchange with the directorate, so that positions taken in earlier rounds remain consistent when the file moves between reviewers.

5. Verification checklist

• □ Confirm the accepting window is the JFDA Directorate of Medical Devices and Supplies
• □ Confirm whether the product falls within sterilants or detergents and takes the device channel rather than the cosmetics channel
• □ Confirm whether the product is laser-based and needs the front-end position of the Ministry of Health Directorate of Professions and Institutions Licensing
• □ Confirm the AR contact can communicate directly with the directorate
• □ Keep an internal escalation path so that a stalled query at the directorate window is raised through formal correspondence rather than left unanswered
• □ Check whether JFDA has recently adjusted the directorate’s internal division of work or accepting window
• □ 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