Local Laboratory Testing Requirements for Devices and IVDs in Jordan

1. Key takeaways

Local laboratory testing in Jordan is conditionally triggered rather than universally required: certain Class IIb and Class III high-risk devices, and certain IVD reagents, may be required to send samples to the JFDA central laboratory or to the Royal Scientific Society of Jordan (RSS) for testing. GRZAN’s conclusion is that whether it is triggered depends on the product risk and the sufficiency of the existing test reports; not all products trigger it. Companies should therefore hold two plans in parallel: one for a cycle without local testing and one for a cycle with it, so that the project can absorb the trigger without replanning from scratch.

• The second conclusion: once triggered, the cycle cost is significant. Local testing stretches the overall registration cycle by a further several weeks to several months (practical estimate), and it adds a batch testing fee of 125 JOD.
• The third conclusion: in 2025 Jordan updated the testing, compliance and market control requirements for medical products, sterilizers and detergents, while at the same time JFDA is equipping its laboratories to WHO and PIC/S requirements. The two directions compound each other: the coverage and the frequency of local testing are trending upward. Both developments point in the same direction: the reliance on purely foreign test data is becoming narrower over time, not wider.

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 core of the trigger judgement is the “sufficiency of the existing test reports”. For products holding CE or FDA approvals, the technical documentation already contains complete performance testing, biocompatibility, electrical safety and sterilisation validation data, so JFDA is more likely to accept these conclusions and the probability of local sample submission falls accordingly. For products on the FSC alternative pathway, which lack the technical review conclusions of a stringent regulatory authority, the probability of being required to submit samples rises (practical estimate). The testing requirement, in other words, moves inversely with the strength of the reference approval behind the dossier.

Insight 2: laboratory capability upgrades will shift the trigger distribution. JFDA has listed the equipping of its laboratories to WHO and PIC/S requirements as a key programme. Once the testing capability is upgraded, projects that previously relied on foreign reports because of insufficient local capability may be brought into the scope of local testing. Companies should plan on the assumption of a rising trigger probability. What was accepted on foreign reports last year may be called in for local verification this year, and the plan should carry that margin rather than assume yesterday’s practice.

Insight 3: batch testing and registration testing are two distinct steps. In the fee schedule, the fee for “batch testing / circulation” is 125 JOD, which points to batch-by-batch testing at the circulation stage; sample testing at the registration stage belongs to the technical evaluation. Both can occur, and companies should budget for them separately. Conflating the two line items is how testing costs end up understated at approval time and disputed at invoice time.

Insight 4: sample delivery must be completed through the AR. All sample delivery must be operated through the AR’s linked account in the JFDA system. The customs clearance, the delivery and the results tracking of the samples all depend on the AR’s execution capability. This is one more reason the selection of the AR should weigh operational capacity, not only price.

Insight 5: the room to contest testing results is limited. Local testing results are the direct basis of JFDA’s technical evaluation; if the results fall short, remediation and a resubmission of samples is usually required, which extends the cycle further. There is no shortcut around a failed local test; the only protection is submitting samples whose existing test reports are complete and defensible in the first place.

4. Practical recommendations

• Assess the probability of sample submission at the product initiation stage. High-risk devices and IVD reagents without CE/FDA approval should be planned for cycle and budget on a “high probability of sample submission” basis.
• Treat a CE or FDA approval as a tool for lowering the probability of sample submission. A reference-country approval brings not only a simplification of the documents, but also the possibility of a testing exemption.
• Budget the registration sample submission and the batch testing (125 JOD) separately.
• Reserve logistics and customs clearance time for sample delivery. Sample entry is subject to the relevant JFDA procedures and should be coordinated with the AR in advance.

5. Verification checklist

• □ Assess the probability of local sample submission for the products to be registered (by risk class and reference-approval status)
• □ Reserve several weeks to several months for local testing in the cycle plan (practical estimate)
• □ Budget the registration sample submission costs and the batch testing fee of 125 JOD separately
• □ Confirm the sample delivery is operated by the AR through the JFDA system account
• □ Check whether the 2025 testing requirement update adds new testing items
• □ Monitor the impact of the progress of JFDA’s laboratory construction on the testing scope
• □ 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