TSE/BSE Certificate Requirements for Jordan Medical Device Imports

1. Key takeaways

Jordan’s importation directives state expressly: all medical device products containing ingredients of animal origin must submit a mad cow disease certificate (TSE/BSE certificate). GRZAN’s conclusion is that this is a stand-alone gate that operates independently of the risk class — even a Class I product triggers it as long as it contains ingredients of animal origin. The trigger follows the composition, not the classification.

• Second conclusion: the TSE/BSE certificate belongs to the documents under the “general conditions for first importation” of the importation directives. Its placement under the general conditions, rather than under conditions reserved for high-risk devices, shows that it applies to all classes.
• Third conclusion: this requirement is consistent with Jordan’s cautious stance toward products containing special ingredients. Products containing pharmaceutical ingredients, ingredients of animal origin, or narcotic or psychotropic substances each face their own separate additional documentation requirements in Jordan. The TSE/BSE gate is simply the most frequently missed of the three.

2. Legal basis

The TSE/BSE certificate requirement and the related controls on special ingredients 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 citation check is repeated whenever a new dossier revision is issued.

3. Expert insights

The observations below reflect GRZAN’s ingredient traceability and supplier documentation work for medical devices containing animal-derived materials destined for Jordan.

Insight 1: the trigger is “containing ingredients of animal origin”, not “having animal-derived material as the main body”. Excipients, stabilisers, coated antibodies, gelatin capsules, collagen matrices and residues of animal-derived culture media may all constitute a trigger. When reviewing product composition, GRZAN requires companies to provide a complete ingredient list traced level by level, rather than looking only at the main material. The traceability exercise therefore starts from the finished product and works backwards through every supplied material. The review is repeated whenever a supplier or a formulation changes.

Insight 2: the TSE/BSE requirement can be stacked with the drug-containing device requirements. The importation directives set out separate documentation requirements for pharmaceutical-preparation-type or drug-containing devices: the original catalogue containing all information (ingredients, indications, contraindications, warnings), the manufacturer’s commitment on shelf life and storage conditions together with the stability declaration, the inner and outer packaging and insert, and the finished product specifications and analytical methods. Assembling both sets under one dossier owner keeps the workload coordinated. A product that is both drug-containing and animal-origin-containing must satisfy 2 sets of requirements simultaneously. Both sets are assembled by the same dossier owner so nothing falls between them.

Insight 3: the certificate must cover the species and tissues of the source animals. A TSE/BSE certificate usually needs to state the animal species, the country of origin, the tissues or body fluids used, and the measures taken to reduce the risk of transmissible spongiform encephalopathies. When requesting the certificate from suppliers, companies should specify the required information fields. Suppliers can usually provide these fields, but only if the request is made early enough in the project.

Insight 4: an alternative material strategy can remove the requirement at its root. For products in development or undergoing a design change, adopting recombinant or synthetic sources in place of animal-derived ingredients removes this documentation requirement and reduces the later regulatory burden. This is the recommendation GRZAN raises at the product planning stage. The assessment is most valuable early, when a material change still costs a development decision rather than a regulatory one.

Insight 5: the supply chain documentation must be traceable. The JFDA may trace back to the manufacturers of the raw materials. Companies should preserve a complete documentary chain of supply, rather than relying only on the self-declaration of the finished device manufacturer. Traceability is demonstrated by documents, and the documents must exist before the question is asked. Traceability is demonstrated by documents, and the documents must exist before the question is asked.

4. Practical recommendations

• First, complete the ingredient traceability at the product initiation stage. List every ingredient and its source item by item and identify whether any ingredient is of animal origin. The output is kept with the product master file for reuse at later registrations. The traceability output is kept with the product master file so it can be reused at every subsequent registration.
• Second, request the complete TSE/BSE certificates from suppliers in advance. Specify the required fields: animal species, country of origin, tissues used and risk control measures. The field list is sent together with the purchase order, not after it.
• Third, for products that are both drug-containing and animal-origin-containing, prepare the two sets of documentation requirements simultaneously. Preparing both in one project plan prevents one from stalling the other.
• Fourth, evaluate alternative materials in successor products. Recombinant or synthetic sources can remove this gate at its root. The evaluation weighs development cost against the recurring documentation burden the animal-origin route carries.

5. Verification checklist

• □ Ingredient traceability of the product has been completed level by level, identifying all animal-origin ingredients
• □ TSE/BSE certificates obtained covering the animal species, country of origin, tissues used and control measures
• □ Confirmed that drug-containing devices additionally require the ingredient catalogue, storage condition commitment and stability declaration
• □ Confirmed that products containing narcotic or psychotropic substances fall under Law No. 23 (2016)
• □ A complete supply chain documentary chain is preserved for traceability
• □ Recombinant or synthetic alternative material options have been evaluated in successor products
• □ 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