Devices with Animal-Origin Components: EDQM Certificate of Suitability and Other Special Certificates

1. Key takeaways

Special ingredients trigger additional certificates, and those certificates sit in two stages: the marketing authorization stage requires a conformity certificate for products of animal origin, while the import permit stage requires, by ingredient, an EDQM certificate of suitability (for animal-origin gelatin), a FANR import permit (radioactive materials), or an EDE batch release certificate (biological-source products or products containing blood, plasma, or human tissue). Our conclusion is that the ingredient determination must be completed at the classification stage, because the processing time for these certificates generally exceeds the 3 working days service window and the 2 months validity of the import permit; late discovery means stranded goods.

• Special ingredients trigger certificates at both the marketing authorization and import permit stages.
• Animal-origin products require a conformity certificate at registration; animal-origin gelatin requires an EDQM certificate of suitability.
• Radioactive materials require a FANR import permit; biological-source products require an EDE batch release certificate.
• Ingredient determination must be finished at the classification stage, before any shipment is planned.
• Certificate lead times generally exceed the 3 working days service window and the 2 months permit validity.
• Certificates processed batch by batch require a supply chain rhythm designed around release timing.
• Late discovery of a triggered ingredient is the costliest scenario, because shipment plans would already be fixed.

2. Legal basis

The regulatory basis combines the EDE service pages for import permits and marketing authorization with subparagraphs of Article 6(1) of Federal Decree-Law No. 38 of 2024. The table below reproduces the instruments cited in the source material and their key points.

3. Expert insights

Insight 1: The trigger for the EDQM certificate of suitability is the animal origin of the gelatin, not merely the presence of gelatin. Our judgment is that EDE is concerned with the source and process controls relevant to transmissible spongiform encephalopathies (TSE), so the trigger is gelatin of animal origin intended for use in humans. Plant-derived or synthetic substitute materials do not trigger this requirement, but the submission file must state the ingredient source explicitly; otherwise the reviewer has no basis to rule it out and a deficiency request will still be issued.

Insight 2: The FANR permit belongs to a separate regulatory line and cannot be replaced by the EDE permit. Radioactive materials require a FANR import permit, which is the mandate of the nuclear regulator and runs in parallel with the EDE medical device permit. Our recommendation is that devices containing radioactive ingredients, or radioactive substances used alongside them, must complete the FANR permit before shipment and carry the permit number into the import declaration; do not attempt to cover this requirement with the EDE marketing authorization.

Insight 3: The batch release certificate means certificate by batch, and the scheduling logic is entirely different from registration certificates. Biological-source products or products containing blood, plasma, or human tissue require an EDE batch release certificate, processed batch by batch rather than per product. Our judgment is that the supply chain rhythm for such products must be designed around batch release: within the 2 months validity of the import permit, release and clearance must be completed, otherwise a new application is required after the permit lapses.

4. Practical recommendations

• Complete the ingredient determination at the classification stage, producing an ingredient list that flags whether special certificates are triggered.
• Where animal-origin gelatin is present, process the EDQM certificate of suitability in advance and explain the source and process controls in the submission file.
• Where radioactive materials are involved, obtain the FANR import permit before shipment and carry the permit number into the import declaration.
• For biological-source products or products containing blood, plasma, or human tissue, process the EDE batch release certificate batch by batch and build it into the supply chain schedule.
• Submit the conformity certificate for products of animal origin as a dedicated chapter at the registration stage, separate from the routine technical documentation.
• When ingredients change, re-determine the trigger conditions and align with the Article 15 requirement for re-approval of significant changes.

5. Verification checklist

• □ Ingredient determination is complete, clarifying whether animal-origin gelatin, radioactive materials, or biological-source materials are present
• □ Where animal-origin gelatin is present, the EDQM certificate of suitability has been obtained and covers the batches to be imported
• □ Where radioactive materials are involved, the FANR import permit has been obtained and the number has been carried into the import declaration
• □ The EDE batch release certificate for biological-source products or products containing blood, plasma, or human tissue has been arranged
• □ The conformity certificate for products of animal origin has been submitted separately in the marketing authorization application
• □ The processing lead times of the special certificates are built into the shipment schedule and do not conflict with the 2 months validity of the import permit
• □ The trigger conditions have been re-determined after any ingredient change

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team prepares MOHAP-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com