Arabic Labeling and Instructions for Use Requirements in Jordan

1. Key takeaways

Jordan requires that medical devices entering retail channels or intended for patient use carry on their outer packaging labels and instructions for use (IFU) content in Arabic, or adopt a bilingual English-Arabic presentation. GRZAN’s conclusion is that the mandatory nature attaches to the condition of “entering retail channels or intended for patient use”, leaving room for exemption in professional settings.

• Second conclusion: the prominence rule is the detail most easily overlooked in practice. The prominence of the Arabic characters on the label (font size, colour contrast, layout salience) must not be lower than that of the English. Shrinking the Arabic characters by one size during layout is a common deficiency item for the JFDA.
• Third conclusion: even where an exemption for the Arabic instructions for use is granted, the outer packaging label must still state 3 items in Arabic — the product name, the local agent’s name and the JFDA registration number (practical estimate). The exemption is partial, not total.

2. Legal basis

The labelling and instructions for use requirements for registration in Jordan rest on the instruments listed below, each shown with its reference, publication date and the location of the relevant provisions.

Provision numbers are subject to the Arabic originals published in the Jordanian Official Gazette and issued by the JFDA; the boundary of the exemption and the prominence requirements are practical estimates.

3. Expert insights

The observations below reflect GRZAN’s label and IFU localisation work for devices entering the Jordanian retail and hospital channels.

Insight 1: the trigger condition for mandatory Arabic is the combination of “channel plus user”. Products intended for patients or retail channels (such as self-testing blood glucose tests, pregnancy self-tests and contact lenses) must carry Arabic; professional equipment used only by hospital departments and not in direct contact with patients may apply for an exemption from the Arabic instructions for use (practical estimate). The assessment is made from the product’s actual distribution model, not from assumptions about the sector.

Insight 2: an exemption does not mean zero obligations. Even where the instructions for use are exempted, the product name, the local agent’s name and the JFDA registration number on the outer packaging label must still be stated in Arabic. These three items are the elements the JFDA checks first during on-site inspections. Verifying these three items takes minutes and prevents the most predictable category of finding.

Insight 3: the checklist of mandatory label elements. Device name (trade name and generic name), manufacturer name and address, authorised representative name and contact details, device class (I/IIa/IIb/III), intended use / indications, contraindications, warnings and precautions, storage and handling instructions, shelf life or expiry date, batch or serial number, sterilisation method (for sterile devices), single-use or reusable designation, CE mark or FDA approval number (where applicable), and country of origin. The list is checked against the artwork before printing, since corrections after printing are the expensive kind.

Insight 4: the depth requirements for the IFU. The instructions for use must contain detailed operating instructions, safety warnings and precautions, installation and set-up instructions (active devices), maintenance and cleaning instructions, troubleshooting guidance, disposal instructions, and electromagnetic compatibility information (active devices). The depth expectation mirrors what reviewers rely on when assessing safe use without hands-on training.

Insight 5: both inner and outer packaging must be submitted. The importation directives expressly require submission of the inner and outer packaging (and the insert, where present). The two are examined separately during registration review. Submitting both versions together avoids the partial-file queries that follow when only one is provided.

4. Practical recommendations

• First, determine the channel and the user before deciding the language strategy. Products intended for patients should be designed bilingually; professional equipment may be designed with partial Arabic once the exemption is confirmed. The language strategy is therefore a distribution decision as much as a translation decision.
• Second, establish prominence checking rules for the Arabic-English layout. The Arabic font size, colour contrast and layout position must not fall below the English; GRZAN recommends setting an equivalence rule at the layout design stage itself.
• Third, turn the three mandatory Arabic statements into a template. The Arabic statements of the product name, the local agent’s name and the JFDA registration number should be made into a standard template for batch reproduction. A template also guarantees that the Arabic wording stays identical across every SKU.
• Fourth, have the translation performed by professional medical translators. Translation errors in warnings and contraindications count as high-risk deficiencies in Jordan. Such errors are not cosmetic; they reach the end user directly.

5. Verification checklist

• □ The product’s channel and users have been assessed and the mandatory scope of Arabic determined
• □ The prominence of the Arabic-English bilingual layout meets the equivalence rule (font, colour, layout)
• □ The outer packaging label carries the Arabic product name, local agent’s name and JFDA registration number
• □ The checklist of mandatory label elements has been verified item by item
• □ The IFU contains operation, warning, installation, maintenance, troubleshooting, disposal and EMC information
• □ Both inner and outer packaging have been submitted as dossier annexes
• □ The professionalism of the medical translation and the consistency of terminology have been re-checked
• □ 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