IVD Registration in Jordan: Classification, Dossier and Testing

1. Key takeaways

In vitro diagnostic products (IVDs) are regulated in Jordan under the medical device regime, but they follow a separate risk classification and clinical evaluation pathway. GRZAN’s conclusion is that an IVD cannot be classified by directly applying the device Class I/IIa/IIb/III rules; it must be handled under the IVD’s own classification system. Trying to force an IVD into a device class usually produces either an over-classified project with wasted effort or an under-classified one that is corrected mid-review.

• The second conclusion: the Jordanian classification examples for IVDs span multiple risk tiers — cholesterol/uric acid testing systems are Class I, pregnancy self-testing is Class IIa, blood glucose self-testing is Class IIb, and HIV blood-donor screening is Class III. The same technology platform falls into different tiers depending on the analyte, so the classification determination must centre on the intended use. Reading the classification from the instrument or the platform, instead of from what the test is used for and by whom, is the most common way IVD projects start down the wrong tier.
• The third conclusion: the IVD documentation requirements carry clear traces of pharmaceutical review. Requirements such as the certificate of analysis (CoA), the analytical methods, the chromatograms of the reference standards and the degradation products, and the stability data carry more weight in an IVD dossier than they do for ordinary devices. A manufacturer preparing an IVD submission should therefore build the analytical package first, not last, since it is the part of the dossier most likely to be scrutinised line by line.

2. Legal basis

Article numbers are subject to the Arabic originals published in the official gazette of Jordan and issued by JFDA; the amounts are the official fees listed in the JFDA fee schedule.

3. Expert insights

Insight 1: the classification is determined jointly by the analyte and the scenario of use. The difference between blood glucose self-testing (Class IIb) and a cholesterol/uric acid testing system (Class I) lies not in the technical complexity but in the consequences of a misjudgement and the scenario of use — in a self-testing scenario there is no professional available to interpret the results, so the risk class is raised. When classifying an IVD, companies should treat “whether it is self-testing” as an important variable. The same reagent can legitimately sit in two different tiers depending only on who reads the result, so the label claims and the intended-use statement must be written with the classification in mind from the start.

Insight 2: analytical performance data are the core of the IVD dossier. Jordan requires the submission of analysis reports for samples of the same batch number, analysis certificates for the reference standards or other materials requiring analysis, material safety data sheets for the reference standards, the composition and quantities of the active and inactive materials, the finished product specifications, all validated test and analysis methods, stability data applicable to laboratory and calculation activities (including storage conditions and validity), and HPLC and GC chromatograms of the samples, the reference standards and the degradation products. This list closely resembles the submission requirements for pharmaceutical active substances. Manufacturers used to device-style dossiers should budget distinctly more analytical effort here, because each element is reviewed as evidence in its own right.

Insight 3: the stability data requirement covers the “entire shelf life”. The stability studies must cover the complete shelf life and include the two dimensions of storage conditions and validity. For cold-chain reagents, this means genuine real-time stability data are required, rather than an extrapolation from accelerated stability studies. Real-time studies take as long as the shelf life itself, so they belong on the critical path of product development, not at the end of it.

Insight 4: IVD reagents are a high-frequency trigger for local testing. Certain IVD reagents may require performance specification verification at the JFDA central laboratory (Amman). The batch testing fee is 125 JOD, incurred batch by batch at the circulation stage.

Insight 5: the outer packaging must use an independent language. The importation directives require the outer packaging to use an independent language (independent language). Combined with Jordan’s Arabic-labelling requirement, the outer packaging and the instructions for use of an IVD should be designed bilingually. The artwork should be checked for both requirements at the design stage, since reprinting packaging late in a project is one of the most expensive corrections available.

4. Practical recommendations

• Make the classification determination centre on the intended use. Clarify the analyte, the scenario of use (self-testing / professional use) and whether the product is used for screening (blood-donor screening falls into the high-risk tier).
• Prepare the analytical data to pharmaceutical standards. Assemble the certificates of analysis, the chromatograms, the reference-standard materials and the material safety data sheets in advance.
• Design the stability data for the entire shelf life. Cold-chain products should rely primarily on real-time stability data, and the storage conditions should be stated in the dossier.
• Reserve budget and cycle for batch testing. The batch testing fee for IVD reagents at the circulation stage is 125 JOD (per batch).

5. Verification checklist

• □ Complete the IVD classification determination on the intended use and the scenario of use
• □ Assemble the certificates of analysis, the analytical methods, the reference-standard materials and the material safety data sheets
• □ Confirm the stability data cover the complete shelf life and include the storage conditions
• □ Prepare the HPLC / GC chromatograms of the samples, the reference standards and the degradation products
• □ Confirm the outer packaging and the instructions for use are designed bilingually in Arabic and English
• □ Reserve a budget of 125 JOD per batch for batch testing
• □ Verify the cited article numbers against the Arabic original 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 JFDA registration applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzan.com