Jordan Family and System Grouping Rules for Device Registration

1. Key takeaways

Jordan recognises two grouped registration approaches — family grouping and system grouping. GRZAN’s conclusion is that applying the grouping rules properly can compress a multi-model product line into a single registration unit, directly reducing the official fees, the documentation workload and the cost of subsequent change management. The grouping decision therefore belongs at the start of the project, where it can shape the whole registration strategy, rather than as an afterthought once individual applications have already been filed.

• The second conclusion: family grouping requires five conditions to be met simultaneously — the same product owner, the same risk classification, a common intended use, common design and manufacturing processes, and variation only within the permitted range. If any one of the conditions fails, the grouping fails.
• The third conclusion: grouping is not a channel for “submitting less material”. A grouped application must still fully present the range of variation across the models in the group and the verification data for the representative model, and the technical review will examine the reasonableness of the variation range. A grouped application, in other words, trades one full dossier for a dossier plus a defensible argument about how much the models within the group are allowed to differ from each other.

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: among the five conditions for family grouping, “common design and manufacturing processes” is the one most often misjudged. Companies frequently group by “same brand, same use” and overlook the commonality of design and processes. When reviewing grouping proposals, GRZAN requires companies to provide the design documents and the process flow charts of each model for a substantive comparison, rather than relying on product naming. Product families that look uniform on a brochure often turn out, on the drawings, to differ in materials, software or sterilisation routes, and any such difference has to be either reconciled or moved out of the group.

Insight 2: system grouping addresses the problem of selling a set of products together. The four conditions for system grouping are: the same product owner; combined use to achieve a common intended use; compatibility when used as a system; and sale under a single system name, or identification of their combined-use relationship in the labels, instructions for use, manuals or catalogues of the components. The third condition (compatibility) and the fourth (identification of the relationship) are the key ones — companies must provide compatibility verification data and state the combined-use relationship clearly in the labelling documents of each component. A system grouping that is real in engineering terms but invisible on the labels will not survive review, because the fourth condition is documented on the face of the packaging.

Insight 3: the economics of grouping can be quantified with the fee schedule. In the JFDA fee schedule, the fee for the market circulation (registration) study is 700 JOD and the fee for the variation study is 25 JOD. For a product line of ten models, the difference in official fees between registering model by model and registering as a family is measured in thousands of Jordanian dinars, and every subsequent change event is charged at 25 JOD, so the change management cost after grouping falls as well. The fee structure thus rewards grouping twice: once at the point of registration and again at every future change event over the life of the certificate.

Insight 4: the cost of a failed grouping is rework. If JFDA finds the grouping invalid, the application will be required to be split; the fees already paid are not refunded upon the split, and the cycle restarts from the beginning. GRZAN recommends confirming the grouping proposal informally with JFDA through the AR before formal submission. That informal confirmation costs little, while a failed grouping costs the split of the application, the non-refundable fees and a restart of the cycle.

4. Practical recommendations

• Carry out a grouping feasibility assessment at the project launch stage. Put the model list, the design documents and the process flow charts side by side, and check the five conditions one by one.
• Prepare the “representative model plus variation range” documentation for the grouping. State clearly which model in the group is the worst case, and explain where the remaining models sit within that range.
• System grouping requires compatibility verification, reflected in the labelling. The labels, instructions for use, manuals or catalogues of the components should expressly state the combined-use relationship.
• Plan ahead for the inclusion of new models later on. Determine whether a new model falls within the variation range permitted for the original grouping; if it does not, a separate registration or a variation application is required. Deciding this before the new model enters production avoids discovering, at the port or at the next change event, that the certificate does not cover it.

5. Verification checklist

• □ Check the five conditions for family grouping one by one and retain the comparison records
• □ Identify the representative model of the group and explain the basis for the worst-case selection
• □ If system grouping is used, complete the compatibility verification and state the combined-use relationship in the labelling of each component
• □ Confirm the grouping proposal informally with JFDA through the AR
• □ Assess the impact of grouping on the official fees (700 JOD per item) and the variation fees (25 JOD per event)
• □ Plan the inclusion route for future new models
• □ 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