Technical Documentation Requirements for Jordan Medical Device Registration

1. Key takeaways

Jordanian technical documentation can be localised on the skeleton of the EU technical documentation, but it cannot simply be transplanted. GRZAN’s conclusion is that the CE technical file covers about 80% of the technical content requirements, and the remainder must be supplemented against Jordan’s specific demands — localisation items, reference-country evidence and pharmaceutical-style format items (practical estimate).

• Second conclusion: the technical documentation must use English as the working language. The labels and instructions for use additionally require Arabic versions.
• Third conclusion: Jordan’s technical review carries pharmaceutical review DNA. The importation directives’ requirements for finished product specifications, analytical methods, certificates of analysis and stability data show that JFDA’s reading habits differ from those applied to purely engineering-style technical files. GRZAN proactively adapts the dossier to these habits when restructuring it. The adaptation is deliberate and follows a fixed internal template.

2. Legal basis

The technical documentation requirements for registration in Jordan are anchored in 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 percentage cited is a practical estimate. The estimate is revisited for each product, since the share of reusable content varies with the device type.

3. Expert insights

The observations below describe how GRZAN restructures an EU technical file into a Jordanian submission, item by item.

Insight 1: the first localisation item is language and format. The technical documentation is submitted in English, and the labels and instructions for use are submitted in Arabic. When companies carry out the translation, they must ensure that the information in the Arabic and English versions is strictly identical — inconsistency is a common deficiency item for the JFDA. The comparison is carried out line by line, not at the level of general similarity.

Insight 2: electrical and climate parameters must be localised. Jordan’s grid parameters are 220V/50Hz, and the plug standard is the European two-round-pin type (practical estimate). The technical documentation and labels of active devices must reflect the parameters applicable to the local grid, and the installation environment requirements in the instructions for use should take the hot and dry conditions into account. Devices rated for other grids must be re-labelled or re-documented, not merely assumed compatible.

Insight 3: reference-country evidence is a Jordan-specific addition. The EU technical file will not contain a complete copy and translation of the CE certificate itself, yet Jordan requires it to be submitted. When restructuring the dossier, companies should place the reference-country approval documents as a stand-alone chapter at the front. Placing these documents where reviewers expect them removes one of the easiest sources of follow-up questions.

Insight 4: reinforcing the pharmaceutical-style format items. For IVDs and reagent-containing products, it is necessary to supplement the certificate of analysis (CoA), analytical methods, chromatograms of standards and degradants, material safety data sheets, and stability data covering the complete shelf life. These may exist in the EU technical file in a different form and must be reorganised according to Jordan’s requirements. Reorganising existing data into the expected format is far cheaper than generating new data after a deficiency letter.

Insight 5: independent presentation of risk analysis and clinical evaluation. Jordan requires submission of the risk analysis (ISO 14971) and the clinical evaluation report (CER). In the EU technical file these two items are usually distributed across different chapters; when restructuring, they should be extracted as stand-alone documents so that reviewers can consult them easily. Extraction also reduces the risk that a reviewer finds one document but misses its companion.

4. Practical recommendations

• First, take the CE technical file as the base document and build a three-category list of “retain — adapt — add”. Retain the technical content, adapt the language and local parameters, and add the reference-country evidence and the pharmaceutical-style format items. The three-category list turns a large restructuring task into a series of small, checkable decisions.
• Second, place the CE certificate, the declaration of conformity and the classification rationale as stand-alone chapters at the front. These three items are the documents the JFDA consults first. Front-loading them shortens the reviewer’s path to the core conformity evidence.
• Third, extract stand-alone risk analysis and clinical evaluation documents. Avoid making reviewers search through the dossier for them. Stand-alone files also make later updates easier to manage when the underlying data changes.
• Fourth, run a consistency check between the Arabic and English versions. GRZAN recommends building a terminology concordance table to ensure that the product name, indications and warnings correspond across the two languages. The concordance table also keeps future label revisions consistent across both languages.

5. Verification checklist

• □ The technical documentation is compiled in English, and the labels and instructions for use in Arabic
• □ The consistency check between the Arabic and English versions has been completed
• □ The electrical parameters of active devices reflect 220V/50Hz (practical estimate)
• □ The CE certificate, declaration of conformity and classification rationale are placed as stand-alone chapters at the front
• □ The risk analysis (ISO 14971) and clinical evaluation report have been extracted as stand-alone documents
• □ For IVDs and reagent-containing products, the certificate of analysis, chromatograms and stability data are complete
• □ The installation environment requirements in the instructions for use take the local hot and dry conditions into account
• □ 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