Jordan FSC Alternative Pathway for Devices Without CE or FDA Approval

1. Key takeaways

For devices with neither a CE certificate nor an FDA approval, Jordan offers a free sale certificate (FSC) alternative pathway: submit the FSC from the country of origin, together with an additional FSC from one of the countries on the reference-country list. GRZAN’s conclusion is that this pathway is workable, but both the documentation burden and the review cycle are heavier and longer than for the CE/FDA pathway. Companies should therefore see the FSC pathway as a fallback to be planned deliberately, not as a default route of equal standing.

• The second conclusion: the reference-country list comprises Switzerland, Australia, Canada, Japan and Norway. Some practical estimates also place the United Kingdom on the list; before submission, companies should reconfirm the latest list with JFDA through the AR (practical estimate).
• The third conclusion: where the country of origin is already on the reference-country list, only the origin-country FSC is needed and no second certificate is required. This is the inverse corollary of the rule that “where the country of origin is a country other than Switzerland, Australia, Japan, Canada and Norway, a free sale certificate from the country of origin must be provided in addition to a free sale certificate from any one of the above countries”.

2. Legal basis

Article numbers are subject to the Arabic originals published in the official gazette of Jordan and issued by JFDA; the reference-country list follows JFDA’s current position.

3. Expert insights

Insight 1: the essence of the alternative pathway is to replace the approval of one stringent regulatory authority with market-access evidence from two free markets. CE and FDA approvals represent conclusions of technical review; an FSC represents only the qualification to sell the product legally in the issuing country. The evidentiary strength of the two is different, and this explains why the alternative pathway carries a heavier documentation burden and a longer cycle. It also explains why JFDA may ask for additional analytical evidence along this pathway: without a stringent authority behind the product, the dossier has to carry more of the proof itself.

Insight 2: the formal requirements for the FSC are strict. The importation directives require submission of the original or the latest duly notarised copy of the certificate. For companies, this means the FSC must go through notarisation and even consular legalisation, with a time cost that typically runs to several weeks (practical estimate: 4 to 6 weeks is the common range). Companies should also confirm early which authority in the origin country issues the FSC and how long that authority itself takes, because the issuing time sits in front of the notarisation and legalisation chain and cannot be compressed afterwards.

Insight 3: the alternative pathway does not change the localisation obligations. Whichever pathway is taken, the Arabic-language labelling and instructions for use, the local representative information, the quality management system certificate (ISO 13485 or the origin-country GMP), the declaration of conformity, the device description and intended use, and the clinical and preclinical data must all be submitted. The pathway chosen only changes how the technical conformity of the product is evidenced; the localisation and quality documentation requirements remain the same in either case.

Insight 4: sample analysis reports may become an additional requirement. Where there is no CE/FDA approval, JFDA may require submission of analysis reports for samples of the same batch number, analysis certificates for reference standards or other materials requiring analysis, material safety data sheets for the reference standards, the composition and quantities of the active and inactive materials, the finished product specifications, all validated test and analysis methods, stability data (including storage conditions and shelf life), and chromatograms of the samples, the reference standards and the degradation products. This list carries clear traces of pharmaceutical review. Companies taking this pathway should read it as a signal that the review behaves closer to a drug application than to a CE/FDA-backed device registration, and that the analytical documentation should be assembled with corresponding care.

Insight 5: the reference-country list varies between sources. Different channels include or exclude certain countries in their descriptions of the list. GRZAN’s approach is to treat the list as a practical-estimate item to be reconfirmed before each submission, rather than as a fixed fact. This is also the reason the reconfirmation should run through the AR, who is the party in direct contact with JFDA and can obtain the current position in writing.

4. Practical recommendations

• First assess whether a CE or FDA approval can be obtained first. If the product is already planned for the EU or the US market, completing one of those approvals before entering Jordan usually saves more time than taking the FSC pathway.
• Front-load the time budget for the FSC. Notarisation and consular legalisation usually take 4 to 6 weeks (practical estimate); they should be placed at the very front of the project plan, not run in parallel with dossier preparation. Because this chain runs ahead of the Cosmo appointment and the on-site submission of originals, any slippage here moves every later milestone.
• Prepare the sample analysis materials early. Applications without CE/FDA are more likely to be asked to supplement analysis reports; GRZAN recommends attaching usable analytical materials already at the first submission.
• Reconfirm the reference-country list with the AR before submission. The list may be adjusted; JFDA’s current position prevails.

5. Verification checklist

• □ Confirm the product genuinely has neither a CE certificate nor an FDA approval and must take the FSC alternative pathway
• □ Confirm whether the country of origin is on the reference-country list, to determine whether a second FSC is needed
• □ Reconfirm the latest reference-country list with JFDA through the AR (practical estimate)
• □ Confirm the FSC is an original or the latest duly notarised copy
• □ Reserve 4 to 6 weeks for the notarisation and consular legalisation of the FSC (practical estimate)
• □ Prepare supplementary materials such as sample analysis reports, reference-standard analysis certificates and material safety data sheets
• □ Confirm the localisation documents (Arabic-language labelling, local representative information) are complete
• □ 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