Batch Testing and Release: When the 125 JOD Batch Testing Fee Applies

1. Key takeaways

The JFDA fee schedule prices batch testing / circulation at 125 JOD, incurred per batch. GRZAN’s conclusion is that this fee covers the testing and release of imported batches at the circulation stage, and that it is a different step from the sampling submitted for technical evaluation at the registration stage — the two are separate procedures and may both occur for the same product. Conflating the two leads to budget errors, because the registration sampling is part of the one-off registration process while batch testing repeats with every shipment.

• Second conclusion: batch testing is a release condition, not a sampling inspection. A batch that has not been tested, or that has failed testing, cannot complete customs clearance and release. The release step is therefore where testing risk becomes commercial risk.
• Third conclusion: in 2025 Jordan updated the testing, compliance and market control requirements for medical products, sterilizers and disinfectants. The items and frequency of batch testing may adjust accordingly, and companies should plan on the basis of an expanded testing scope. An expanded scope assumption protects the timeline as well as the budget.

2. Legal basis

The batch testing obligation and its fee rest on the following instruments.

Clause numbers must be verified against the Arabic originals published in the Official Gazette of Jordan and issued by the JFDA; the amounts are the official fees listed in the JFDA fee schedule.

3. Expert insights

Insight 1: batch testing and registration sampling are two independent steps. The sampling for technical evaluation at the registration stage addresses the conformity determination of the product and takes place before market entry; batch testing addresses the quality consistency of a specific imported batch and takes place at the circulation stage. The two differ in legal basis, purpose and cost (the former is not listed separately under the batch testing item, while the latter is 125 JOD). The distinction matters for planning: the first cost is paid once per registration, while the second is paid for as long as the product keeps flowing into the market.

Insight 2: IVD reagents are a high-frequency target of batch testing. The performance of IVD reagents is significantly affected by the batch, so the JFDA’s demand for batch testing of such products is higher than for ordinary devices. When building a cost model for IVDs, companies should treat 125 JOD per batch as a recurring cost rather than an occasional one. A high-volume IVD importer should therefore model testing cost as a function of shipment frequency, not as a fixed line.

Insight 3: the 2025 update of the testing requirements will affect the test items. Jordan updated the testing, compliance and market control requirements for medical products, sterilizers and disinfectants in 2025. The updated test items may increase, which would lengthen the testing cycle per batch and raise costs (practical estimate). Current testing cycles should therefore be treated as a floor rather than a ceiling when estimating lead times.

Insight 4: the handling of a failed test depends on its nature. A batch that fails testing may be required to be returned, destroyed or rectified. Companies should agree with the AR, in the agreement, the responsibility for handling failed batches and the sharing of the associated costs. Whichever route is taken, the goods are stranded until the matter is resolved, so the commercial consequences concentrate in the importer’s inventory.

Insight 5: the testing cycle affects the inventory strategy. Batch testing takes time. Companies should include the testing cycle in the replenishment lead time when planning their inventory in Jordan, so as to avoid stockouts. Even a testing window of a few days per batch compounds across a year of shipments.

4. Practical recommendations

• Include 125 JOD per batch in the recurring operating cost model. For IVD reagents and high-risk consumables in particular, estimate the annual testing cost from the expected number of import batches. The estimate should be refreshed with each new shipment forecast.
• Reserve replenishment lead time for the testing cycle. Plan the inventory on the basis that release comes only after testing is complete, and avoid relying on in-transit stock. The lead time buffer should be reviewed whenever the test scope changes.
• Agree in the agreement the responsibility for handling failed batches. Specify the cost sharing and the decision process for return, destruction or rectification. The decision process should name who decides and how fast.
• Track the changes in test items following the 2025 update of the testing requirements. Confirm the current items and cycles through the AR.

5. Verification checklist

• □ The 125 JOD per batch has been included in the recurring operating cost model
• □ Confirm whether the products to be imported are high-frequency batch testing targets (IVD reagents, high-risk consumables)
• □ Replenishment lead time has been reserved for the batch testing cycle
• □ The responsibility and cost sharing for failed batches have been agreed in the agreement
• □ The current test items and cycles after the 2025 update have been confirmed through the AR
• □ The two cost categories of registration sampling and batch testing have been separated to avoid budget confusion
• □ The cited clause numbers have been re-verified against the Arabic originals of the Official Gazette

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 coordinates local importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com