Jordan 2019 Circulation Criteria for Medical Devices, Sterilisers and Detergents

1. Key takeaways

The 2019 Criteria for the Circulation of Medical Devices, Sterilisers and Detergents is the foundational connecting document in Jordan’s current device regulatory system. GRZAN’s judgement is that a company that studies only the registration guidelines and ignores this circulation criteria will run into repeated setbacks at warehouse acceptance, circulation compliance and market surveillance in turn.

The second conclusion is that the criteria extend “product compliance” into “compliance of circulation conditions”. Registration status of the product, warehouse conditions, flow records and market withdrawal handling form a continuous chain of obligations; a break at any link prevents an obtained registration from converting into actual sales.

The third conclusion is that, together with the 2017 registration guidelines and the 2011 GMP guidelines, this criteria forms one of the three core subordinate documents of Jordanian device regulation. A company’s compliance architecture in Jordan should be built around these three documents, not around the importation directives alone.

• The 2019 criteria is the connecting layer between registration approval and actual market operation.
• Registration, warehousing, flow records and withdrawal handling form one continuous obligation chain.
• The criteria, the 2017 guidelines and the 2011 GMP guidelines are the three core subordinate documents.
• Registration files are tied to a JFDA-accepted physical warehouse under the named AR.

The criteria explains why warehouse quality is a registration matter and not merely a logistics matter. Because the registration file points to a specific, JFDA-accepted warehouse, the physical conditions of that warehouse are part of the authorisation itself. Diligence on a candidate AR therefore reads like a site audit: acceptance status, monitoring records, segregation areas and record continuity all say something about whether the registration they host will hold up under surveillance.

2. Legal basis

The circulation obligations rest on the following instruments.

Provision numbers are subject to the Arabic original texts issued in the Jordanian Official Gazette and by JFDA.

3. Expert insights

Insight 1: the criteria binds registration to physical warehousing. A Jordanian device registration file is associated with a physical warehouse under the AR’s name that has been accepted by JFDA. The warehouse must conform to good storage practices (GSP) or the warehousing standards set by JFDA, with temperature and humidity monitoring and a segregated area for non-conforming products. This binding means that changing the AR often amounts to transferring or re-issuing the registration certificate, not a simple change of entity. Companies should therefore confirm the acceptance status and the transfer mechanics before any change of AR is signed, not after.

Insight 2: the circulation conditions double as the surveillance checklist. JFDA’s continuous monitoring and inspection actions at premises where devices and supplies circulate, at points of sale and at clinics draw most of their inspection items from the circulation criteria. When GRZAN assists companies facing on-site inspections, it pre-checks the site item by item against this document. The same checklist works before inspections arrive: a distributor trained to the criteria will keep the records that inspectors ask for first, and gaps surface during internal review rather than on the inspection day.

Insight 3: the criteria and the GMP guidelines form a pincer at both ends. The 2011 GMP guidelines govern the production end and the 2019 circulation criteria govern the distribution end; each end carries its own premises approval requirement — in the JFDA fee schedule, the approval fee for production premises and for warehousing premises is 700 JOD each. When budgeting, companies should include premises approval on both sides.

Insight 4: the procedural basis for withdrawal and recall sits here. The circulation criteria covers the handling rules for products leaving the market. When a company initiates a field safety corrective action (FSCA) in Jordan, the procedural requirements must be confirmed against this document; the manufacturer’s home-country recall procedure alone is not sufficient.

4. Practical recommendations

• Include the circulation criteria in the AR due diligence list. Beyond the number of certificates held, verify on site whether the candidate AR’s warehouse has passed JFDA acceptance, whether temperature and humidity monitoring records are continuous, and whether the non-conforming product segregation area is set up independently.
• Plan the registration certificate and the warehouse together. Before changing warehouses or ARs, first confirm the transfer path and cost of the registration certificate to avoid a gap where the certificate points to the old warehouse while goods sit in the new one.
• Schedule the annual self-inspection against the criteria and archive the findings, so that the audit trail exists before any JFDA inspection asks for it.

5. Verification checklist

• □ Obtain and study the version of the 2019 circulation criteria currently in force
• □ Check whether the AR’s warehouse has passed JFDA acceptance and conforms to GSP
• □ Check whether the warehouse temperature and humidity monitoring records are continuous and retrievable
• □ Check whether the non-conforming product segregation area is set up independently
• □ Record the acceptance status of the warehouse in the AR due diligence file, so that the linkage between registration and premises is documented at appointment
• □ Confirm the transfer path of the registration certificate when changing the AR or the warehouse
• □ Complete an annual self-inspection against the criteria clauses and keep the records
• □ Re-verify the cited provision numbers against the Arabic original texts 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 Jordan Food and Drug Administration (JFDA) registrations, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com