Jordan Reliance Pathway: Registering Devices with CE or FDA Approval

1. Key takeaways

The core feature of Jordan’s device regulatory system is a high degree of reliance on reference countries: JFDA accepts EU CE certification (under the MDD or MDR frameworks) and US FDA approvals (510(k), De Novo or PMA) as the primary basis for registration. GRZAN’s conclusion is that companies holding CE or FDA approvals face a significantly lower documentation burden and less review resistance in Jordan than companies without reference-country approvals. In practical terms, the reference approval answers the question JFDA would otherwise have to answer itself, which is why the entire registration conversation changes once a CE certificate or an FDA approval is on the table.

• The second conclusion: reliance does not mean exemption from review. JFDA retains the right to examine the dossier, to request supplementary information and even to require additional assessment; the validity of the certificate is a precondition, and expired certificates are not accepted.
• The third conclusion: this mechanism reinforces JFDA’s internationalisation path. JFDA has listed obtaining a WHO regulatory authority classification and PIC/S and ICH membership as first-priority items for 2025–2027; as the degree of internationalisation rises, the credibility given to reference-country approvals will increase further.

2. Legal basis

Article numbers are subject to the Arabic originals published in the official gazette of Jordan and issued by JFDA.

3. Expert insights

Insight 1: CE and FDA stand in an “or” relationship, not an “and” relationship. The importation directives are worded as requiring submission of an original or the latest duly notarised copy of either of the following certificates: a US FDA certificate; an EU CE certificate. A company needs to provide only one of the two; dual certification is not required. Holding both, however, gives the company the freedom to submit whichever certificate has the longer remaining validity and the closer match to the product as marketed in Jordan.

Insight 2: the CE requirement for Class III devices goes one level deeper. For Class III devices, Jordan requires the simultaneous submission of the EC declarations of conformity for Full Quality Assurance and for Design Examination. This mirrors the EU conformity assessment route for Class III devices. When pulling together the CE documentation, companies must confirm whether the conformity assessment modules covered by the certificate are complete. If only one of the two declarations is available, the missing declaration will have to be obtained from the notified body before the dossier can be considered complete for a Class III application.

Insight 3: the classification can also follow the reference country. JFDA accepts both the EU MDR/MDD and the US FDA classification systems. For products holding a CE certificate, the EU classification is usually accepted; for products holding an FDA approval, the US classification can be mapped into the Jordanian system. Companies should submit their existing classification rationale documents together with the dossier, as the basis for the classification.

Insight 4: the boundary of reliance lies at the localisation requirements. Reference-country approvals solve the question of “technical conformity”, not the question of “localisation”. Arabic-language labelling and instructions for use, local representative information and the marking obligation for the JFDA registration number are not waived by holding CE or FDA approvals. In practice, GRZAN has observed that most rejected shipments fail at the localisation stage rather than at the technical stage. The lesson is that the reference approval should never be read as a substitute for the Jordan-specific labelling and marking work; the two tracks run in parallel and both must be finished before shipment.

Insight 5: the validity of the certificates must cover the review period. If a reference-country certificate expires during the review, a precondition lapses. GRZAN recommends that the remaining validity of the certificates be no less than 6 months (practical estimate). Checking the expiry dates of all supporting certificates at the moment the project starts, rather than at the moment of submission, avoids discovering a lapsed precondition halfway through the review.

4. Practical recommendations

• Obtain CE or FDA approval first before starting Jordan registration. If the company’s Middle East footprint includes Jordan, front-loading the reference-country approval pays off on both the timeline and the cost.
• Pull together the complete CE documentation package. For Class III products, confirm that both the Full Quality Assurance and the Design Examination declarations of conformity are available.
• Match the validity of the reference-country approvals against the Jordanian review period. Work backwards from the practical Class III cycle of approximately 8 months to set the point at which the certificates must be reinforced.
• Prepare the localisation documents separately. Reference-country approvals do not exempt Arabic-language labelling, local representative information or the registration number marking obligation. The localisation track should be given its own owner, its own deadline and its own review, exactly like the technical track.

5. Verification checklist

• □ Confirm the company holds one valid CE certificate or FDA approval document
• □ For Class III, confirm that both the EC Full Quality Assurance and the Design Examination declarations of conformity are available
• □ Check whether the remaining validity of the reference-country certificates covers the review period (practical estimate: no less than 6 months is recommended)
• □ Submit the existing classification rationale documents together with the dossier
• □ Confirm the Arabic-language labelling and the local representative information have been prepared separately
• □ Confirm the certificates are originals or the latest duly notarised copies
• □ 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