Shelf Life and Stability Declaration Requirements in Jordan

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

1. Key takeaways

Jordan requires manufacturers to submit two declaration documents: the commitment on the shelf life of the medical device and its storage conditions, and the stability declaration on those conditions. GRZAN’s conclusion is that these two requirements originate from the documentation provisions for “pharmaceutical-preparation-type or drug-containing devices”, but in practice they apply equally to IVD reagents and to products sensitive to storage conditions (practical estimate).

Second conclusion: the stability data must cover the complete shelf life and include both the storage conditions and validity dimensions. For IVD reagents, the wording of the importation directives is: stability data applicable in laboratory and calculation activities, covering storage conditions and validity. The two dimensions are presented together so the reviewer can see that the data supports both.
Third conclusion: these three documents (the shelf life and storage condition commitment, the stability declaration and the stability data) form the “stability triangle” of the Jordanian dossier, and none of them can be missing.

2. Legal basis

The shelf life, storage condition and stability declaration requirements rest on the instruments listed below, each shown with its reference, publication date and the location of the relevant provisions.

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 (shelf life, storage condition commitment and stability declaration)
Good Manufacturing Practice Guidelines for Medical Devices	Good Manufacturing Practice Guidelines for Medical Devices	2011	Provisions on inspection, testing and storage control
Criteria for the Circulation of Medical Devices, Sterilisers and Detergents	Criteria for the Circulation of Medical Devices, Sterilisers and Detergents	2019	Provisions on storage and circulation conditions

Provision numbers are subject to the Arabic originals published in the Jordanian Official Gazette and issued by the JFDA.

3. Expert insights

The observations below reflect GRZAN’s stability documentation work for IVD reagents and storage-sensitive devices entering the Jordanian market.

Insight 1: the stability requirements form a closed loop with the circulation criteria. The 2019 circulation criteria require warehouses to have temperature and humidity monitoring and a quarantine area for nonconforming products; the storage condition declaration is the corresponding document on the dossier side of that requirement. The storage conditions a company declares must actually be capable of being met by the AR’s warehousing conditions; otherwise a gap in conditions will appear at the circulation stage. The verification is done before submission, because a mismatch discovered after registration is far harder to correct.

Insight 2: the shelf life declaration must be consistent with the label. The expiry date rules and batch number coding rules on the label must be consistent with the shelf life declaration in the dossier. Inconsistency is a common deficiency item for the JFDA. The comparison is made element by element, covering every date format and batch rule that appears in either place.

Insight 3: the stability data requirements for cold-chain products are stricter. For IVD reagents requiring refrigeration, the data Jordan requires should support the entire shelf life. The acceptability of accelerated stability extrapolation carries uncertainty in practice, so GRZAN recommends relying primarily on real-time stability data (practical estimate). Real-time data also carries the seasonal variation that reviewers recognise as evidence of genuine storage behaviour.

Insight 4: storage conditions must take the local climate into account. Jordanian summers are hot, and the transport and warehousing condition declarations for cold-chain and ambient products should cover the local extreme conditions. GRZAN recommends stating in the declaration the temperature range during transport and the measures for handling deviations. Extreme-condition coverage is what distinguishes a declaration written for Jordan from one copied from another market.

Insight 5: the stability data interlock with batch testing. The batch testing fee at the circulation stage is 125 JOD (per batch), and the test items usually target stability-sensitive indicators. The stability data in the dossier should be able to support the judgement criteria of the batch testing. Aligning the dossier data with the testing criteria prevents an avoidable failure at the port of entry.

4. Practical recommendations

First, compile the “stability triangle” as a stand-alone chapter. Present the shelf life and storage condition commitment, the stability declaration and the stability data together in one place so reviewers can consult them easily. The chapter is indexed so each of the three documents can be located without searching the dossier.
Second, verify the consistency between the declarations and the label. The expiry date rules and batch number coding rules must be fully identical in both places. The check is repeated whenever either the label or the declaration is revised.
Third, for cold-chain products rely primarily on real-time stability data. Avoid over-reliance on accelerated stability extrapolation (practical estimate). Real-time studies are therefore started earlier in development, accepting a longer calendar in exchange for cleaner review.
Fourth, cover the local extreme climate conditions in the declaration. State the transport temperature range and the deviation handling measures, and match them against the AR’s warehousing capability in a verification exercise. The matching verification is documented, so the dossier can show that the warehouse delivers what the declaration promises.

5. Verification checklist

□ The shelf life and storage condition commitment document has been compiled
□ The stability declaration document has been compiled, covering each condition in the commitment
□ The stability data cover the complete shelf life, including storage conditions and validity
□ Cold-chain products rely primarily on real-time stability data (practical estimate)
□ The declared storage conditions have been verified against the actual capability of the AR’s warehouse
□ The expiry date and batch number rules on the label are consistent with the dossier declarations
□ The declaration covers local extreme climate conditions and transport deviation handling measures
□ 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.

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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.

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