Jordan Registration Dossier Checklist for Medical Devices

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The composition of a Jordanian registration dossier can be broken down into four parallel tracks: the corporate qualification track (the applicant’s commercial registration certificate and the authorised representative authorisation documents), the conformity proof track (a CE certificate or FDA certificate, or the FSC alternative combination), the technical documentation track (quality management system certificate, declaration of conformity, device description and intended use, risk analysis, test reports, clinical evaluation report), and the localisation track (inner and outer packaging, instructions for use, catalogue, Arabic-language documents). GRZAN’s conclusion is that the overwhelming majority of rejections occur on the first track and the fourth track, not on the technical documentation track.

Second conclusion: the dossier must be prepared with English as the working language, while Arabic is used for labels, instructions for use and the locally facing portion of the document set.
Third conclusion: the completeness of the dossier determines when the statutory clock starts. The 60 working days processing timeline published on the Jordan Trade Portal runs from the date of submission of a complete dossier; an incomplete dossier means the timeline has not yet begun.

2. Legal basis

The following instruments govern the content requirements of the registration dossier for medical devices in Jordan. Each entry is listed with its reference, publication date and the location of the relevant provisions within the instrument.

Title of regulation	Reference number	Publication date	Provision / location
Medical Devices (Including Sterilizers and Disinfectants) Importation Directives	Medical Devices Importation Directives Including Sterilizers & Detergents	Currently effective version	General conditions for first importation (document list)
Registration Guidelines for Medical Devices	Registration Guidelines for Medical Devices	2017	Technical documentation requirements provisions
Good Manufacturing Practice Guidelines for Medical Devices	Good Manufacturing Practice Guidelines for Medical Devices	2011	Quality management system documentation provisions
JFDA fee schedule	Official JFDA fee items	Currently effective version	Circulation (registration) study 700 JOD

Provision numbers are subject to the Arabic originals published in the Jordanian Official Gazette and issued by the JFDA; the amounts are the official fees listed in the JFDA fee schedule.

3. Expert insights

The observations below set out where the JFDA’s attention settles when a Jordanian dossier reaches the review desk, based on GRZAN’s dossier preparation work for this market.

Insight 1: the commercial registry certificate is the high-frequency rejection point on the corporate qualification track. The applicant must submit a Commercial Registry Certificate issued by the Ministry of Industry and Trade, and its registered business scope must cover the importation of medical devices or medical consumables. An authorised representative whose registered scope does not match this requirement is the most common reason for rejection at the formal review stage.

Insight 2: the three-way structure of the conformity proof track. The company chooses one of three options: a CE certificate, an FDA certificate, or the FSC alternative route (home-country FSC plus reference-country FSC). The certificate must be submitted as the original or a recently issued, duly notarised copy — the requirement that it be “duly notarised” means that a plain photocopy is not accepted.

Insight 3: the generic items on the technical documentation track. Quality management system certificate (ISO 13485 or home-country GMP), declaration of conformity (DoC), device description and intended use, risk analysis (ISO 14971), test reports (EMC, biocompatibility and so on), and clinical evaluation report (CER). Class III devices additionally require an EC full quality assurance and design examination declaration of conformity.

Insight 4: the three fixed items on the localisation track. Inner and outer packaging, instructions for use (IFU), and the catalogue. All three must be submitted and must present Arabic content. An exemption arrangement may exist for the Arabic instructions for use of professional medical equipment, but the product name, the local agent’s name and the JFDA registration number on the outer packaging label must still be stated in Arabic (practical estimate).

Insight 5: dossier structure and JFDA’s pharmaceutical review DNA. The importation directives’ requirements concerning finished product specifications, analytical methods, certificates of analysis and stability data show that JFDA’s technical review carries the mindset of a pharmaceutical review. When GRZAN compiles a dossier, it proactively organises the material around this reviewing preference.

4. Practical recommendations

First, build the dossier directory along the four tracks and tick each item off one by one. Treat the corporate qualification track and the localisation track as the portions with the highest rejection risk and review them with particular care.
Second, prepare the technical documentation in English and the labels and instructions for use in Arabic. The information carried in the two language versions must be consistent with each other.
Third, bring certificate validity into the final check before submission. GRZAN recommends that the remaining validity of the ISO 13485 and home-country GMP certificates be no less than 6 months (practical estimate).
Fourth, run a completeness self-check before submission. A dossier judged to be incomplete will postpone the start of the 60-working-day timeline. The self-check is therefore treated as a gate rather than a formality.

5. Verification checklist

□ The applicant’s commercial registration certificate is complete and its registered scope covers the importation of devices or consumables
□ The AR authorisation documents (LoA/PoA) have completed notarisation and consular legalisation
□ The CE certificate or FDA certificate is the original or a recently issued, duly notarised copy
□ If the FSC route is taken, both the home-country and reference-country FSC are in place
□ The remaining validity of the ISO 13485 or home-country GMP certificate is no less than 6 months (practical estimate)
□ The declaration of conformity, device description and intended use, risk analysis and test reports are complete
□ Inner packaging, outer packaging, instructions for use and catalogue are complete and contain Arabic
□ The dossier completeness self-check is finished, securing the start of the 60-working-day timeline
□ The cited provision numbers have been re-verified against the Arabic text 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 prepares JFDA-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.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.

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