Jordan medical device regulatory resources

Competent authority

Jordan Food and Drug Administration (JFDA) — Medical Devices and Supplies Directorate is the competent authority that registers and monitors imported and locally manufactured medical device…

Devices and supplies technical committee

The JFDA Director General forms committees to execute the Law, including a Devices and Medical Supplies Committee that also covers sterilants and disinfectants.

Circulation prohibited until DG authorization

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 Direct…

2019 Basis for import and circulation of medical supplies

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. 55…

Intended purposes of a medical supply

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,…

Definition of medical supply (مستلزم طبي)

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…

MDD-derived فئات Class I, IIa, IIb and III plus an active-implant فئة.

فئة (1) — Class I, فئة (2أ) — Class IIa, فئة (2ب) — Class IIb, فئة (3) — Class III, فئة المستلزمات الطبية الفعالة التي تزرع في الجسم — Active Implants

Circulation requires DG decision after testing

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 te…

Import routes handled by the Import Section

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…

China NMPA approval: not reference

statement: 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 For…

China NMPA approval: origin evidence only

statement: 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…

Eligibility of the authorized person

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…

Who may deal with JFDA

Only the responsible pharmacist (الصيدلي المسؤول) or the authorized person (الشخص المفوض) may follow up and complete transactions with JFDA under the Testing Regulation.

Manufacturing-site adoption under the Higher Committee

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 Co…

Sample must conform to the technical file

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 pac…

JFDA online portal for medical supplies and cosmetics

JFDA operates an online portal (Login — JFDA) at https://application.jfda.jo/Cosmo covering medical supplies (medical devices) and cosmetics transactions.

Inner and outer packaging and the accompanying leaflet are part of the regulated product

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…

GMP inspection of local factories

JFDA inspects local factories to verify application of good manufacturing practice principles and follows up on them thereafter.

Site accreditation and cGMP/ML certificates

The Inspection Section of the Medical Devices and Supplies Directorate administers: initial and renewed manufacturing site accreditation for medical supplies, initial and renewed cGMP certi…

EMRC radiation practice and source licence

Radiation

TRC type approval (الموافقة النوعية)

Wireless / radio

Circulation (registration) study

JOD 700

Technical-Committee-reviewed study

JOD 100

Class I and Class IIa outside the Annex 7 list · No registration — import permission from the Director General only

0 days

Class IIb and Class III · Registration by the Medical Devices and Supplies Committee

45 working days

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 working days

Renewal of registration required

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…

Changes only per approved basis

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.

Registrable variations

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 conditi…

Batch (تشغيلة) definition and numbering

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 m…

No source-verified answer is published for this dimension yet.

Testing exemption for non-commercial imports

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 Genera…

No source-verified answer is published for this dimension yet.

Adverse-effect reporting service

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@jf…

Batch withdrawal and corrective actions

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…

Post-market testing and forced withdrawal

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, t…

Approval of advertisement brochures and technical leaflets

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 ma…

Objections Committee decision clock

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 f…

Appeal of testing-regulation decisions within 30 days

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 3…