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Jordan Medical Device Registration

Jordan Medical Device Registration

Navigating Medical Device Registration in Jordan: JFDA Regulations, Process, and Market Outlook

Updated on 26/01/24

Regulatory Authority: Jordan Food and Drug Administration

Jordan Food and Drug Administration (JFDA) have been created in 2003 as the sole national competent authority for drug safety & efficacy and food safety and quality.

JFDA is an independent public sector regulatory institution whose main objectives are to ensure that: –

  • Food is safe, wholesome, and properly labelled.
  • Drugs are safe and efficacious.
  • Safety of all products explicitly stated in the enforced drug and pharmacy law.

Tasks and Duties

  • Supervision and inspection of the quality and suitability of food in accordance with technical rules, specifications and standards stipulated in the legislations in force.
  • To achieve the requirements and take measures in connection with drug and pharmacy law, also to guarantee and supervise the safety and quality of medication in accordance with the rules and standards specified in the legislations in effect.
  • To exercise any other supervision and inspection in connection with food stuffs and drug specified in the Food Law and Drug and Pharmacy Law in effect.

Link for Regulatory Authority: http://www.jfda.jo

Local Regulation: Medical Devices Importation Regulations

Classification:

  • Class I
  • Class IIa
  • Class IIb
  • Class III

Listing or Registration Requirements:

  • Appoint an authorized representative (AR) in Jordan to submit the application.
  • Request an electronic appointment through the link: http://application.jfda.jo/Cosmo
  • Applicant shall pay fees needed
  • Fill out the application form and submit all required documents.
  • If approved, the applicant will receive a registration certificate with 5 years validity. 

Documents Required for Registration:

  • An original notarized CE certificate or FDA certificate (CFG). For Class III, both EC Full Quality assurance and Design Examination
  • Declaration of Conformity
  • ISO certificate
  • Free Sales Certificate from country of origin, and from one of the following countries (Swiss, Australia, Canada, Norway, UK), if the medical device does not have a CE or FDA certificate
  • Composition certificate from manufacturer, signed and stamped.
  • Finished product specification, should have a reference number or a date
  • Shelf life and storage declaration
  • Certificate of Analysis, mentions the production and expiry date and the batch number
  • Method of Analysis
  • BSE/TSE certificate
  • Stability study for the whole shelf life
  • Inner and Outer labels
  • IFU
  • Catalogue

Registration Timeline:

  • Class I sterile or measuring function – 4 months
  • Class I other (excluding export only devices) – 4 months
  • Class IIa – 4 months
  • Class IIb – 4 – 8 months
  • Class III – 8 months 

Registration Fee: $141, In case the Medical Device need analysis additional fees to be paid as: $71 

License Validity: 5 years

Special Labelling Requirements: Labelling should be in English. The Sponsor’s name and information must be included in the labelling.

Market overview:

The Medical Devices market in Jordan is anticipated to achieve a projected revenue of US$362.10 million in 2024. The largest segment within this market is Cardiology Devices, with an estimated market volume of US$55.93 million in 2024. Forecasts indicate a consistent annual growth rate (CAGR 2024-2028) of 5.59%, leading to an expanded market volume of US$450.10 million by the year 2028.

Who should make this communication:

  • Manufacturer
  • Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

  • Act as your Authorized representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]

 

 

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