Jordan 2025 Regulatory Updates on Testing, Compliance and Market Control
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
In 2025, Jordan updated the testing, compliance and market control requirements for medical products, sterilisers, detergents and cosmetics. GRZAN ranks this as the third differentiated lever in the Jordanian market: the update covers both the pre-market testing thresholds and the intensity of post-market controls, making it a two-way tightening rather than a change that only affects one end of the product lifecycle. Companies positioned anywhere between importation and retail sale are inside the scope in one way or another.
The second takeaway: the update aligns with the JFDA’s internationalisation path. The JFDA has listed obtaining WHO regulatory authority classification and PIC/S and ICH membership as a first-priority item for 2025–2027, and the update of testing and market control requirements is a supporting move along that path, not a standalone adjustment. Read this way, the direction of travel is toward harder local verification, not toward lighter reliance on foreign paperwork.
The third takeaway: companies already holding certificates in Jordan must run a gap analysis. The updated testing items may have increased, and existing test reports may no longer be sufficient to support products that are already on the market. The window to run that analysis calmly is before the next shipment or the next inspection makes the gap concrete.
2. Legal basis
| Instrument | Number / identifier | Publication date | Provision / locator |
|---|---|---|---|
| 2025 update of testing, compliance and market control requirements | JFDA 2025 regulatory updates | 2025 | Testing requirements provisions; compliance requirements provisions; market control requirements provisions |
| Medical Devices Importation Directives Including Sterilizers & Detergents | Medical Devices Importation Directives Including Sterilizers & Detergents | Current version in force | Provisions on general conditions for first importation |
| JFDA 2025–2027 priorities | Jordanian Government Budget Department, chapter 2704 | 2025 | First-priority item paragraph (WHO classification, PIC/S, ICH; equipping laboratories to WHO and PIC/S requirements) |
| JFDA fee schedule | Official JFDA fee items | Current version in force | Batch testing / circulation 125 JOD |
Provision locators are subject to the JFDA 2025 announcements and the official chapter notes of the Jordanian Government Budget Department; the amounts are official fees listed in the JFDA fee schedule. The priorities chapter is the document that shows why the update was made; the fee schedule shows part of what it costs to comply.
3. Expert insights
Insight one: three dimensions updated at once shows this is a systemic adjustment, not a single-point patch. Testing (technical thresholds), compliance (procedural requirements) and market control (regulatory intensity) were all revised simultaneously, which usually means the JFDA’s overall regulatory posture toward the category has changed. Companies that respond only to the testing change will miss the procedural and inspection-side consequences, which is where most of the operational friction actually lands.
Insight two: sterilisers and detergents are explicitly within the scope of the update. This is consistent with the import directives, which bring sterilisers and detergents under device regulation. Affected companies should prepare compliance material on the basis of “device regulatory requirements” rather than “chemical product requirements”, since the authority treats them as devices across the import and market control tracks. Sourcing, packaging and documentation choices made under a chemical-product mindset will surface as deficiencies on the device track.
Insight three: laboratory capability upgrades are the physical foundation of the testing update. The JFDA is equipping its laboratories to WHO and PIC/S requirements. Once testing capability is in place, items previously accepted on the basis of foreign reports because local capability was lacking will be brought into local testing scope, and the probability of local sample submission rises (practical estimate).
Insight four: stronger market control is paired with continuing inspection campaigns. The JFDA continues to run monitoring and inspection campaigns at premises where devices and consumables circulate, at points of sale and at clinics. The updated market control requirements will show up in inspection items and inspection frequency, so the change is visible in the field, not only on paper. An inspection regime that was already continuous will simply have more to check for.
Insight five: the batch testing fee of 125 JOD is the recurring cost anchor after the update. Increases in testing items are usually accompanied by rises in batch testing frequency or scope, so companies should build flexibility around 125 JOD per batch into their cost models instead of treating the figure as a one-off entry.
4. Practical recommendations
First, run a gap analysis for products already certified in Jordan. Compare the updated testing items against current test reports to confirm whether they remain sufficient for the products that are already on the market.
Second, reserve time and budget for new testing. Both the registration sample submission and the batch testing stages need to be reassessed (practical estimate), because additional items stretch both the timeline and the per-shipment cost.
Third, for sterilisers and detergents, review dossiers against device regulatory requirements. Confirm that the application channel, document structure and label language all meet the device-track requirements.
Fourth, establish a quarterly review mechanism. Testing and market control requirements are adjusted through circulars and announcements, so they should be tracked quarterly rather than reviewed only when a shipment is refused. A fixed quarterly rhythm turns scattered announcements into a managed change register the company can act on.
5. Verification checklist
- □ A gap analysis of certified products against the updated 2025 testing items is complete
- □ Time and budget are reserved for new testing items (practical estimate)
- □ Batch testing at 125 JOD per batch is built into the recurring cost model
- □ Dossiers for steriliser and detergent products are reviewed against device regulatory requirements
- □ The current list of updated testing items is confirmed through the AR
- □ A quarterly mechanism for tracking testing and market control requirements is in place
- □ The updated content is verified against JFDA official announcements and the Arabic originals
Regulatory information verified as of October 29, 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 adverse event reporting and recall coordination with the JFDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us