Jordan Vigilance and Adverse Event Reporting Requirements for Medical Devices

1. Key takeaways

Jordan requires adverse event reporting for medical devices, and the reporting obligation covers three categories of parties: manufacturers who become aware that an adverse event has occurred with their device in Jordan, authorised representatives (ARs) who receive adverse event reports from healthcare institutions, patients or other sources, and healthcare institutions themselves, including hospitals, pharmacies and medical centres. The GRZAN conclusion is that vigilance obligations in Jordan operate on multiple parallel channels: the same event can reach the authority from several directions at once, and each channel carries its own duty to report. A manufacturer therefore cannot assume that the AR has filed the report on its behalf, and silence on one channel is not cured by activity on another.

The second takeaway: the JFDA provides an adverse event reporting form through its online services portal (services.jfda.jo). Reports may be submitted by hospitals, pharmacies and medical centres, and the form captures information on the reporting party, the device involved, a description of the event and the patient outcome. In practical terms, this is the entry point through which individual adverse events enter the Jordanian system, so the quality and completeness of what is filled in determines how the event is handled downstream.

The third takeaway: Jordan’s device vigilance system shares its origins with the national pharmacovigilance system. Within the JFDA there is a dedicated Rational Drug Use and Pharmacovigilance Department, and the national pharmacovigilance database covers safety signals across all regulated health products, not only medicines. Devices are therefore drawn into an existing safety infrastructure rather than a system built from scratch.

2. Legal basis

Clause numbers are subject to the Arabic originals published in the Jordanian Official Gazette and by the JFDA. The table above identifies the instruments and the locators that carry the reporting obligation; the exact clause numbering should always be confirmed in the Arabic text before it is relied on in a submission or a procedure.

3. Expert insights

Insight one: a vigilance system that grew out of pharmacovigilance signals a comparatively mature institution. Jordan has already established a national pharmacovigilance database and issued guidance on the detection and reporting of adverse reactions. Device vigilance borrows the same infrastructure, which means that its reporting processes and signal-handling mechanisms are more developed than those of many markets of comparable size. For companies, the practical consequence is that reports filed through this system are processed on established tracks, and the authority is experienced in working with safety data.

Insight two: the vigilance duties of the AR are statutory. Under the 2019 circulation criteria and the import directives, AR obligations include handling post-market surveillance, complaints and vigilance activities. This duty is not discharged by contractual arrangements; an agreement can only define how the parties cooperate internally on these activities. In other words, the contract allocates work, but it cannot reallocate the legal responsibility away from the AR.

Insight three: timely reporting of serious adverse events is the core requirement. Manufacturers and ARs should establish clear processes for receiving, recording and reporting adverse events occurring in Jordan, keep records of every adverse event reported in Jordan regardless of severity, and report serious adverse events to the JFDA promptly (practical estimate). The distinction matters: record-keeping covers everything, while prompt notification targets the serious subset.

Insight four: JFDA market surveillance includes active monitoring. The JFDA conducts random sampling and testing of devices on the market in its quality control laboratories, inspects distribution channels to verify compliance with storage and handling requirements, reviews the ongoing compliance of labelling and advertising, and monitors adverse event reports and safety signals through the national vigilance system. Together these form a four-dimensional surveillance network, and vigilance is one of its active lines rather than a passive filing repository.

Insight five: the 2025 update of market control requirements will reinforce post-market oversight. In 2025 Jordan updated the testing, compliance and market control requirements for medical products, sterilisers and detergents. A strengthening on the market control side is typically accompanied by more detailed vigilance reporting requirements, so companies should expect the reporting expectations around their products to become more specific rather than more lenient.

4. Practical recommendations

First, establish a Jordan-specific vigilance process. Define the path from receipt of a report by the AR to notification of the JFDA, together with the responsible persons and deadlines, and quantify these in the agreement. A generic global process is not enough, because the Jordanian channels and the AR’s statutory role need to be visible in the procedure.

Second, retain records of all adverse events. Events reported in Jordan should be recorded regardless of severity, so that they are available for JFDA inspection whenever the authority asks to see them.

Third, appoint an operational owner for reporting through the JFDA portal. The reporting form collects the reporting party, the device, the event description and the patient outcome, so it should be completed by a person who is familiar with the product and can describe the event accurately.

Fourth, link vigilance data back to the risk documentation. Adverse event information should feed into the risk management documentation, closing the post-market loop between field experience and the risk file.

5. Verification checklist

• □ A Jordan-specific vigilance process is in place, defining the path, responsible persons and deadlines
• □ The AR’s vigilance reporting duties and deadlines are quantified in the agreement
• □ Records of all adverse events reported in Jordan are retained, regardless of severity
• □ An operational owner for reporting through the JFDA online portal (services.jfda.jo) is designated
• □ A mechanism exists for the timely reporting of serious adverse events to the JFDA (practical estimate)
• □ Vigilance data is linked into the risk management documentation and kept updated
• □ Vigilance-related changes in the 2025 market control requirements update are tracked
• □ Cited clause numbers are verified against the Arabic originals of the Official Gazette

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