Explore the medical device requirements currently available for Jordan, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Approval of the wording of an advertisement (brochure) or technical leaflets for a registered medical supply, sterilant or disinfectant is a JFDA service, i.e. such promotional/technical materials for registered products require JFDA approval.
What expires, what is retained periodically, and when must renewal start?
Registered medical supplies, sterilants and disinfectants are subject to renewal of registration (تجديد التسجيل); renewal applications are handled by the Registration Section of the Medical Devices and Supplies Directorate.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
No change may be made to materials covered by Article 3 of Law 12/2013 (which include devices and supplies) except in accordance with the basis approved at JFDA.
Changes to a registered supply, sterilant or disinfectant handled as separate JFDA services include: leaflet (نشرة داخلية) amendment, outer and/or inner packaging amendment, storage-condition change or shelf-life extension (or reduction), addition of a pack size, composition change, and adoption of a final specification.
A 25 JOD study fee applies to change requests for paragraph (أ) materials (see typed findings).
Is the product a device, IVD, accessory, software, or borderline product locally?
Purposes of a medical supply include: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis/monitoring of injury or handicap or compensation for them; detection, compensation for or modification of the anatomical structure; regulation of pregnancy; sterilization of medical and surgical devices; and providing information for a medical purpose via in-vitro examination of specimens taken from the human body.
A medical supply is any material, means, device, instrument or laboratory reagent used alone or in combination with other items, including software necessary for its use and approved by the manufacturer, intended for humans for the listed purposes, without a pharmacological, immunological or metabolic effect on the human body.
Exclusion clause: دون أن يكون له تأثير على جسم الإنسان دوائياً أو مناعياً أو تمثيلاً غذائياً.
Circulation (التداول) under Law 12/2013 covers transport, possession, distribution, offering for sale, gifting, donation, purchase, import, introduction and use.
Which evidence, local deltas, formats, and signatures are required?
A submitted sample (defined as the final product including inner and outer packaging and the accompanying leaflet) must conform to the specifications in the technical file for secondary packaging materials; a non-conforming sample is referred to the committee for decision even if it passed testing.
Confirms a technical file (ملف فني) with approved specifications is part of the submission.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The authorized person (الشخص المفوض), who represents the importer, manufacturer or distributor-agent and is accredited with the Medical Devices and Supplies Directorate, must be specialized in the work, hold at minimum a diploma, and be an employee of the entity whose transactions he follows up.
Only the responsible pharmacist (الصيدلي المسؤول) or the authorized person (الشخص المفوض) may follow up and complete transactions with JFDA under the Testing Regulation.
Which establishment licences, importer permissions, and distribution controls apply?
Adoption (approval) of manufacturing sites for medicines and for materials designated by the Higher Committee from Article 3(b) materials (which include devices and supplies) is a Higher Committee function under Law 12/2013.
Administered for supplies by the Inspection Section (see qms facts).
What regulator fee applies to this class, route, event, and date?
The Prime Minister, upon recommendation of the Minister of Health, may exempt batches imported as gifts/donations to a government entity from the per-batch testing/circulation fees of Art. 13(a) of Testing Regulation 41/2024.
Which label and IFU elements, languages, symbols, and translation controls apply?
Under Jordan's device testing regulation the 'sample' (العينة) that is submitted for examination and against which conformity is judged is defined as the final product of any medical supply, steriliser, disinfectant or cosmetic preparation, expressly including the inner and outer packaging and the leaflet accompanying it. The leaflet (النشرة) and both packaging layers are therefore regulated elements of the product, not marketing material. Where a sample fails to satisfy the specifications stated in the technical file as regards the secondary packaging materials — the inner and outer packaging, the leaflet accompanying it and other specifications — or where the laboratory report records an observation (ملاحظة) on the sample, the Director General decides what to do with it on the recommendation of the committee, notwithstanding that the sample passed the test.
Source is Arabic; both excerpts are quoted verbatim with an English translation. The published PDF has a defective text layer: it carries kashida/letter-spacing runs and reverses the lam-alef ligature (لا is rendered as ال), so words such as 'النهائي' extract as 'النهلللللائي' and 'مستلزم' as 'مسللللللتلام'. The excerpts below repair those two mechanical artifacts only; no wording was changed. The Arabic wording was read against the glyph layout, and the repaired words were confirmed against the same regulation's Art. 2 and Art. 9 as cited by the registry's existing D09 fact dossier.sample-technical-file-conformity, which quotes the identical article. This fact concerns the label/leaflet as a regulated element of the product; it does not state a language requirement — see the unresolved note for D11.
Which current law, regulation, guidance, and transition provisions apply?
Circulation of medical devices and supplies, sterilants and disinfectants and related products is prohibited until they are authorized (إجازتها) under instructions issued by the JFDA Director General in coordination with relevant official bodies.
Law in force 30 days after publication in Gazette No. 5244 of 1 Oct 2013; replaced Provisional Law 80/2001.
The Basis for Import and Circulation of Medical Supplies including Sterilants and Disinfectants 2019 (أسس استيراد وتداول المستلزمات الطبية 2019) was published in the Official Gazette No. 5569 of 1 Apr 2019 and is effective from its publication date.
Effective from 2019-04-01
Full text of the 2019 Basis could not be located as an openable official document; classification/validity/timeline details remain unresolved.
JFDA service fees are set by the Fees and Rewards Regulation No. 19 of 2015 (published in Official Gazette No. 5333 of 16 Mar 2015, effective from publication, repealing Reg 72/2003); the device circulation-fee paragraph (ط) was added by the 2020 amendment (Gazette No. 5646, 16 Jun 2020).
Effective from 2015-03-16
Footnote: paragraph added by the amending regulation for 2020 published in Gazette No. 5646 of 16 Jun 2020.
JFDA Law No. 41 of 2008 (قانون المؤسسة العامة للغذاء والدواء) is cited by JFDA as governing legislation for medical-device and supplies services, alongside the Drug and Pharmacy Law 12/2013.
The full text of Law 41/2008 as published on jfda.jo is a scanned PDF without a text layer, so provisions could not be quoted.
Testing of Medical Supplies, Sterilants and Disinfectants and Cosmetics Regulation No. 41 of 2024 governs mandatory testing and circulation approval of devices/supplies; issued by Royal will upon the Council of Ministers decision of 5 Jun 2024 under Art. 98(a) of Law 12/2013, repealing Regulation 89/2017.
Issued 2024-06-05 (Council of Ministers decision); effective 30 days after gazette publication per Art. 1.
Which current form, portal, account, and submission package must be used?
JFDA operates an online portal (Login — JFDA) at https://application.jfda.jo/Cosmo covering medical supplies (medical devices) and cosmetics transactions.
Which QMS, audit, inspection, and certificate scope is accepted or required?
JFDA inspects local factories to verify application of good manufacturing practice principles and follows up on them thereafter.
The Inspection Section of the Medical Devices and Supplies Directorate administers: initial and renewed manufacturing-site accreditation for medical supplies, initial and renewed cGMP certificates, initial and renewed ML certificates, and certification of true copies of cGMP/ML certificates.
Section also handles destruction (إتلاف) of medical supplies and supply complaints.
Which recall, FSCA, notice, and authority-coordination duties apply?
The Follow-up and Audit Section of the Medical Devices and Supplies Directorate carries out withdrawal of batches (تشغيلات) of medical supplies and cosmetics from the local market and takes corrective-action measures for medical supplies and cosmetics.
Medical supplies, sterilants, disinfectants and cosmetics on the market are subject to post-marketing testing; if a product fails testing and a decision banning its circulation is issued, the batch is withdrawn in accordance with instructions issued for that purpose.
Which registration, notification, listing, reliance, or conformity route applies?
No device/supply, sterilant or disinfectant subject to testing may be circulated until it passes testing and circulation is approved by decision of the JFDA Director General; this covers tested registered items, unregistered items selected for testing, imported batches (including those arriving as donation/gift), and every medical-gas batch.
The Import Section of the Medical Devices and Supplies Directorate processes: import of registered supplies with or without testing (تحلل / بدون تحليل), import of unregistered supplies with testing, import of samples for registration purposes, completion of customs declarations, personal import of supplies and devices, re-export, and export for repair and return.
Unregistered supplies may be imported only with testing (وتحلل), consistent with Art. 4(c) of Testing Regulation 41/2024.
JFDA Medical Devices and Supplies Directorate — Registration Section (قسم تسجيل الأجهزة الطبية والمستلزمات): registration as circulation authorization (إجازة تداول) of supplies/sterilants/disinfectants, renewal of registration, variations, free-sale certificates and sample analysis
null
Free-sale certificates (شهادات حرية بيع) are issued by the same section.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)
Yes
Accepted as origin-market evidence in the registration annexes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
JFDA's binding circulation rules (Annex 1, item 4) require the registration file to contain ONE of an exhaustively listed set of conformity credentials: an FDA Certificate to Foreign Government, an FDA 510(k), a CE certificate from an EU Notified Body, a Japanese MHLW free-sale certificate, or a country-of-origin free-sale certificate paired with a free-sale certificate from Switzerland, Australia, Canada, Norway or the United Kingdom. China/NMPA is not among the listed authorities, so an NMPA registration certificate alone does not satisfy the requirement and confers no abridged review.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
jordan
All imported medical supplies/devices subject to JFDA registration (Class I sterile/measuring, IIa, IIb, III, active implants); NMPA Class I/II/III alike
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2019-04-01
Source passage: ٤- النسخة الأصلية أو نسخة مختومة ختماً أصلياً من كاتب العدل في بلدها (Notary Public) أو من غرفة الصناعة والتجارة أو أي جهة رسمية معتمدة في بلد المنشأ ... لأي من الشهادات التالية: ٤:١ شهادة FDA المسماة (Certificate to Foreign Government) ... ٤:٢ شهادة 510 K ... ٤:٣ شهادة CE صادرة عن جهة معتمدة لدى دول الاتحاد الاوروبي والمعروفة بـ Notified body ... ٤:٤ شهادة حرية بيع من اليابان صادرة عن Ministry of Health & Welfare Labour. ٤:٥ شهادة حرية بيع (Free Sale Certificate) من جهة رسمية في بلد المنشأ بالإضافة إلى شهادة حرية بيع من أي من الدول التالية: (سويسرا، استراليا، كندا، النرويج، المملكة المتحدة) في حال كون منشأ المستلزمات الطبية من غير هذه الدول
Prior approval / evidence record
Where a device is made in a country outside the named list, JFDA accepts a free-sale certificate from an official body in the country of origin as part of the file, but only when supplemented by a free-sale certificate from Switzerland, Australia, Canada, Norway or the UK. An NMPA-based Chinese FSC is thus admissible origin evidence but must state that the device is freely sold in China, carry a validity period, name the manufacturer/marketing-rights holder and site, and be accompanied by one of the five listed countries' FSCs; no abridged review follows.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
jordan
All imported medical supplies/devices not holding FDA CFG/510(k), CE or Japanese FSC, i.e. the typical position of an NMPA-only device
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2019-04-01
Source passage: ٤:٥:١ أن تنص على أن المستلزمات الطبية مسموح ببيعها في بلد المنشأ وتعتمد أي من الصيغ التالية: تسوق بحرية Freely marketed ... ٤:٥:٢ ان تحمل مدة صلاحية (Validation time) وبخلاف ذلك تعتبر مدة صلاحية الشهادة خمس سنوات من تاريخ اصدارها. ٤:٥:٣ أن تذكر اسم الشركة الصانعة أو الشركة مالكة حق التسويق وموقع التصنيع.
Regulatory reference
Testing methods may follow the methods stated in the technical file, official pharmacopoeias, adopted Jordanian standards (Art. 5(a)), or methods established by validation/verification studies and recognized international references (Art. 5(b)).
Prior approval / evidence record
EU CE Mark
Yes
The أسس adopt the EU directives by reference for the class axis, and the annexes require the CE certificate and a free-sale certificate from the country of origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
An application for circulation of a supply or disinfectant subject to registration and testing is not accepted until the sample passes the initial examination (الفحص الأولي); if the sample fails the initial examination it is referred to the committee, and a second failure is referred to the technical committee for rejection.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Medical supplies, sterilants or disinfectants imported in non-commercial quantities or for specifically named patients are exempted from mandatory testing by decision of the Director General upon the committee's recommendation.
The Import Section also operates a personal-import route for supplies and devices.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
The Objections Committee (chaired by the Director General) reviews objections to decisions issued under the Law and must decide within one month of filing the objection; its decisions are final.
Quorum: at least five members including the chair or deputy; decisions by majority of four members.
The responsible pharmacist or authorized person may object to any decision issued under Testing Regulation 41/2024 before the Objections Committee (formed under Art. 13 of the Law) within 30 days of being notified of the decision, attaching grounds and supporting documents.
Which UDI, device listing, database, and traceability duties apply?
The testing and circulation regime operates per batch (تشغيلة): a batch is a defined number of production units of a supply, sterilant, disinfectant or cosmetic manufactured from the same materials under the same conditions in one run or an integrated series of runs, homogeneous and carrying a number (batch number).
What is reportable, by whom, where, in what format, and by what deadline?
JFDA operates a service for reporting adverse effects and complaints arising from use of devices, medical supplies and cosmetics: channels are the JFDA website, e-mail (info@jfda.jo; jpc@jfda.jo), telephone (+962-6-5632000) and the main building; the service is free of charge, has a 4-day completion time, and issues an inspection report on the investigation results.
Supporting documents may include adverse-effect reports, malfunction reports and product safety observations.
jordan:medical-device
jordan
MDD-derived فئات Class I, IIa, IIb and III plus an active-implant فئة.
Jordan classifies medical supplies by the safety/risk of use axis defined in the JFDA أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019, which adopts the EU medical device directives by reference rather than publishing national classification rules.
i
فئة (1) — Class I
low
iia
فئة (2أ) — Class IIa
medium
iib
فئة (2ب) — Class IIb
high
iii
فئة (3) — Class III
highest
active-implant
فئة المستلزمات الطبية الفعالة التي تزرع في الجسم — Active Implants
highest
JFDA
official-source-verified
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019, المادة 2 (تعريف الفئة)
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2026-08-29
The definitions article defines الفئة as the group a medical supply falls under by safety or hazard of use, and divides it into فئة (1) Class I, فئة (2أ) Class II a, فئة (2ب) Class II b, فئة (3) Class III, and a فئة for active medical devices implanted in the body (Active Implants), as set out in Medical Devices Directive 93/42/EEC and Active Implantable MDD 90/385/EEC; laboratory reagents form a separate فئة الكواشف المخبرية under In vitro diagnostics Directive 98/79/EEC.
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 — عنوان الأسس وسند إصدارها
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2026-08-29
The Official Gazette title block records that these أسس are issued under article 7/ك of the Jordan Food and Drug Administration Law No. 41 of 2008 and article 5 of the Drug and Pharmacy Law No. 12 of 2013 as amended, by JFDA board decision in session No. 54 of 20/2/2019, so the class axis is the binding national one.
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019, المادة 2
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2026-08-29
Jordan
jordan
JO
🇯🇴
Jordan Food and Drug Administration
JFDA
middle-east
3
MDD-derived فئات Class I, IIa, IIb and III plus an active-implant فئة
class-i-iia-unregistered
Class I and Class IIa outside the Annex 7 list
low
No registration — import permission from the Director General only
0
0
days
official-verified
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 (Official Gazette no. 5570, p. 1722; JFDA board session No. 54 of 20/2/2019) — Art. 3(b)(3) 45-working-day committee decision, Art. 5 registration scope, Art. 7 ten-year renewal, Art. 13 thirty-day appeal
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2019-02-20
2026-08-30
0
0
days
No
No
No
class-iib-iii
Class IIb and Class III
high
Registration by the Medical Devices and Supplies Committee
45
45
working-days
official-verified
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 (Official Gazette no. 5570, p. 1722; JFDA board session No. 54 of 20/2/2019) — Art. 3(b)(3) 45-working-day committee decision, Art. 5 registration scope, Art. 7 ten-year renewal, Art. 13 thirty-day appeal
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2019-02-20
2026-08-30
4
8
months
No
Yes
Yes
annex-7-and-medicinal-form
Any class listed in Annex 7, in pharmaceutical form, drug-containing, a surgical suture, a disinfectant or sterilant, or carrying a medical claim
Registration by the Medical Devices and Supplies Committee
45
45
working-days
official-verified
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 (Official Gazette no. 5570, p. 1722; JFDA board session No. 54 of 20/2/2019) — Art. 3(b)(3) 45-working-day committee decision, Art. 5 registration scope, Art. 7 ten-year renewal, Art. 13 thirty-day appeal
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2019-02-20
2026-08-30
4
8
months
No
Yes
Yes
EU CE Mark
Yes
The أسس adopt the EU directives by reference for the class axis, and the annexes require the CE certificate and a free-sale certificate from the country of origin
FDA 510(k)
Yes
Accepted as origin-market evidence in the registration annexes
Yes
Authorized person (الشخص المفوض) of a Jordanian importer
No
Not recognized
10 years — Art. 7 renews registrations that have run ten years
2026-08-30
official-verified
أسس تداول المستلزمات الطبية والمعقمات والمطهرات لسنة 2019 (Official Gazette no. 5570, p. 1722; JFDA board session No. 54 of 20/2/2019) — Art. 3(b)(3) 45-working-day committee decision, Art. 5 registration scope, Art. 7 ten-year renewal, Art. 13 thirty-day appeal
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D8%A3%D8%B3%D8%B3_%D8%AA%D8%AF%D8%A7%D9%88%D9%84_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D8%A7%D9%84%D9%85%D8%B9%D9%82%D9%85%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D9%85%D8%B7%D9%87%D8%B1%D8%A7%D8%AA_%D9%84%D8%B3%D9%86%D8%A9_2019-0.pdf
2019-02-20
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by JFDA. Appoint a Authorized person (الشخص المفوض) of a Jordanian importer.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to JFDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
JFDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. JFDA may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, JFDA issues Jordan market authorization certificate.
1-2 weeks
✅
jordan
Jordan
JO
JFDA
10
10
JOD
No
700
700
JOD
No
circulation-study
Circulation (registration) study
JOD
700
JOD 700
Per study
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
technical-committee-review
Technical-Committee-reviewed study
JOD
100
JOD 100
Per study
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
import-invoice-approval
Import invoice approval
JOD
10
JOD 10
Per invoice
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
batch-testing-circulation
Batch testing / circulation
JOD
125
JOD 125
Per batch
Doubled for priority handling.
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D9%81%D8%AD%D8%B5_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D9%85%D8%B3%D8%AA%D8%AD%D8%B6%D8%B1%D8%A7%D8%AA_%D8%A7%D9%84%D8%AA%D8%AC%D9%85%D9%8A%D9%84_%D8%B1%D9%82%D9%85_(41)_%D9%84%D8%B3%D9%86%D8%A9_2024-2.pdf
Jordan FDA Testing Regulation 41/2024 Art. 13: batch and GLP fees
2024-01-01
2026-08-25
site-approval
Site approval
JOD
700
JOD 700
Per approval
Re-evaluation: JOD 350.
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
glp-certificate
GLP certificate grant, renewal, or scope extension
JOD
1000
JOD 1,000
Per certificate event
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D9%81%D8%AD%D8%B5_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D9%85%D8%B3%D8%AA%D8%AD%D8%B6%D8%B1%D8%A7%D8%AA_%D8%A7%D9%84%D8%AA%D8%AC%D9%85%D9%8A%D9%84_%D8%B1%D9%82%D9%85_(41)_%D9%84%D8%B3%D9%86%D8%A9_2024-2.pdf
Jordan FDA Testing Regulation 41/2024 Art. 13: batch and GLP fees
2024-01-01
2026-08-25
objection-filing
Objection filing
JOD
100
JOD 100
Per objection
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
change-study
Change (variation) study
JOD
25
JOD 25
Per change
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
certificate-issuance
Certificate issuance
JOD
20
JOD 20
Per certificate
Certified copy: JOD 10.
exact-current
official-verified
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
2020-06-16
2026-08-25
2026-08-25
official-verified
Jordan FDA Fees Regulation 19/2015 (as amended 2020)
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D8%A7%D9%84%D8%B1%D8%B3%D9%88%D9%85_%D9%88%D8%A7%D9%84%D9%85%D9%83%D8%A7%D9%81%D8%A2%D8%AA_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%A4%D8%B3%D8%B3%D8%A9_%D8%A7%D9%84%D8%B9%D8%A7%D9%85%D8%A9_%D9%84%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1__%D8%B1%D9%82%D9%85_(19)_%D9%84%D8%B3%D9%86%D8%A9_2015_%D9%88%D8%AA%D8%B9%D8%AF%D9%8A%D9%84%D8%A7%D8%AA%D9%87_(2).pdf
2020-06-16
2026-08-25
Jordan FDA Testing Regulation 41/2024 Art. 13: batch and GLP fees
https://www.jfda.jo/ebv4.0/root_storage/ar/eb_list_page/%D9%86%D8%B8%D8%A7%D9%85_%D9%81%D8%AD%D8%B5_%D8%A7%D9%84%D9%85%D8%B3%D8%AA%D9%84%D8%B2%D9%85%D8%A7%D8%AA_%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9_%D9%88%D9%85%D8%B3%D8%AA%D8%AD%D8%B6%D8%B1%D8%A7%D8%AA_%D8%A7%D9%84%D8%AA%D8%AC%D9%85%D9%8A%D9%84_%D8%B1%D9%82%D9%85_(41)_%D9%84%D8%B3%D9%86%D8%A9_2024-2.pdf
2024-01-01
2026-08-25
2026-08-25
exact-current
Yes
jordan
Jordan
low
emrc-radiation-practice-and-source-licence
EMRC radiation practice and source licence
Ionizing Radiation
Mandatory If Feature
Radiation Facility Source Or Worker
Radiation Protection and Nuclear Safety and Security Law No. 43 of 2007, together with Regulation No. 8 of 2013 on the bases and conditions for granting licences and permits for radiation work, makes the Energy and Minerals Regulatory Commission the single authority that permits and licenses radiation facilities, practices, sources and radiation workers, including individual licences for each device and source. EMRC publishes the practice-specific licensing instructions in its radiation-work legislation register — among them licensing requirements for radiation practices in dental centres and clinics, the licensing and inspection guide for therapeutic radiology practice, licensing of consultancy services, and licensing requirements for radiation protection officers.
candidate
trc-type-approval
TRC type approval (الموافقة النوعية)
Radio Spectrum
Mandatory At Import
Telecommunications Or Terminal Equipment
The Telecommunications Regulatory Commission grants the type approval that both permits specified types of telecommunications and terminal equipment to be used and authorises their entry into the Kingdom. Applications run through the automated type-approval system (ETAS) under the TRC instructions on obtaining type approval for telecommunications devices and regulating their entry into the Kingdom; radio equipment applications are filed per model with the Radio Spectrum Management Directorate and the fees are payable in advance.
candidate
EMRC
radiation-work legislation and licensing instructions register
https://emrc.gov.jo/AR/List/%D8%A7%D9%84%D8%AA%D8%B4%D8%B1%D9%8A%D8%B9%D8%A7%D8%AA_%D9%88%D8%A7%D9%84%D8%AA%D9%86%D8%B8%D9%8A%D9%85_%D9%84%D9%84%D8%B9%D9%85%D9%84_%D8%A7%D9%84%D8%A5%D8%B4%D8%B9%D8%A7%D8%B9%D9%8A
TRC
type approval regulatory provisions and ETAS filing for telecommunications devices
https://trc.gov.jo/AR/List/%D8%A7%D9%84%D8%A3%D8%AD%D9%83%D8%A7%D9%85_%D8%A7%D9%84%D8%AA%D9%86%D8%B8%D9%8A%D9%85%D9%8A%D8%A9_%D8%A7%D9%84%D9%85%D8%AA%D8%B9%D9%84%D9%82%D8%A9_%D8%A8%D8%A7%D9%84%D9%85%D9%88%D8%A7%D9%81%D9%82%D8%A7%D8%AA_%D8%A7%D9%84%D9%86%D9%88%D8%B9%D9%8A%D8%A9
