Jordan Objection Procedure: 30 Working Days to Challenge Decisions
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
A rejected Jordan registration application is not the end of the road: the applicant has the right to file an objection within 30 working days of being notified of the relevant decision of the devices committee. GRZAN’s conclusion is that this is an institutionally designed remedy within the Jordan registration system, not an ad hoc arrangement — the JFDA fee schedule expressly lists the objection application fee as 100 JOD, so both the procedure and the fee line up. For companies, the practical meaning is that a rejection is a procedural event with defined next steps, not a wall; the response to it can be planned like any other project task.
- The second conclusion: 30 working days is a short window. Given that the AR needs time to complete the internal assessment, the reinforcement of documents and the submission, companies should start the assessment the moment an unfavourable decision is received, not in the latter half of the window. An objection argued well needs evidence gathering, a written argument and the AR’s submission work, and all three consume days that the 30 working days do not replenish.
- The third conclusion: an objection and a fresh application are two different paths. An objection targets the factual or legal basis of the original decision and costs 100 JOD; a fresh application is charged at the market circulation (registration) study rate of 700 JOD, and the cycle restarts from the beginning. The economic difference between the two is significant. The choice between them is therefore a business decision as much as a regulatory one, and it should be made on the strength of the case rather than on habit.
2. Legal basis
| Name of regulation | Reference / number | Date of publication | Article number / provision |
| Medical Devices Importation Directives Including Sterilizers & Detergents | Medical Devices Importation Directives Including Sterilizers & Detergents | version currently in force | objection procedure provisions (objection filed within 30 working days of notification of the devices committee’s decision) |
| Registration Guidelines for Medical Devices | Registration Guidelines for Medical Devices | 2017 | review decision and remedy provisions |
| JFDA fee schedule | JFDA official fee items | version currently in force | objection application 100 JOD; market circulation (registration) study 700 JOD |
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 objection window runs from “receipt of the notification”, not from “the making of the decision”. This distinction is critical in practice — time may elapse between the making of the decision and the arrival of the notification, and the window counts from the latter. Companies should require the AR to keep complete evidence of when the notification arrived. Without that record, the company cannot demonstrate where it stands inside the window, and a technically timely objection can be lost to an unprovable date.
Insight 2: working days, not calendar days. Thirty working days is roughly six calendar weeks; after deducting Jordan’s weekend (Friday and Saturday) and the public holidays, the time actually available is shorter than an intuitive estimate would suggest. Planning the objection calendar in working days, with the holidays mapped in from the start, is the only way to know the true last filing date.
Insight 3: the design of the fee schedule shows that objections are a routinely used procedure. The JFDA fee schedule lists the objection separately as a 100 JOD fee item, alongside the variation study (25 JOD) and the certificate issuance (20 JOD). Fee design at this level of granularity usually indicates a stable frequency of use of the procedure. The objection is thus an ordinary instrument of the system, and companies should not hesitate to use it merely because it feels adversarial.
Insight 4: an objection is more economical than a fresh application. An objection costs 100 JOD against 700 JOD for a fresh application — a cost ratio of 1:7 (both are official fees in the JFDA fee schedule). Where the decision genuinely contains contestable points, the objection should be the first-choice path.
Insight 5: an objection does not stay the execution of the decision. Companies should not assume that filing an objection suspends the effect of the unfavourable decision. During the objection period, import and sales arrangements should be planned on the assumption that the unfavourable decision is already in force. Any action that depends on the registration proceeding as originally expected should be deferred until the objection outcome is known.
4. Practical recommendations
- Start the objection feasibility assessment on the very day the unfavourable decision is received. Determine whether the unfavourable decision is a question of fact finding (the evidence can be reinforced), a question of legal application (the provisions can be invoked) or a question of classification judgement (the rationale can be re-argued). The type of question determines what kind of material the objection can realistically add, and therefore its prospects.
- Have the AR record the date and the manner of arrival of the notification completely, and calculate the window deadline backwards from that date.
- Decide on the principle of “objection first”. If a contestable point exists, take the objection route first (100 JOD); consider a fresh application (700 JOD) only when no basis for contest is confirmed.
- Do not schedule import actions that depend on the decision during the objection period.
5. Verification checklist
- □ Record the date and the manner of arrival of the devices committee’s decision notification and calculate the 30 working day window backwards
- □ Complete the objection feasibility assessment (fact finding / legal application / classification judgement)
- □ Confirm the objection fee of 100 JOD is included in the budget
- □ Compare the cost and the cycle of the objection (100 JOD) against a fresh application (700 JOD)
- □ Do not schedule import actions dependent on the original application during the objection period
- □ Confirm the specific submission format and material requirements for objections with JFDA through the AR
- □ 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
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us