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FAQs

  1. What is a medical device ?
  2. What is the Medical Device Establishment Licensing (MDEL) ?
  3. Who Should Enroll ?
  4. How To Enroll ?

1. What is a medical device ?

'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
  1. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
    • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
    • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
    • Investigation, replacement, modification, or support of the anatomy or of a physiological process,
    • Supporting or sustaining life,
    • Control of conception,
    • Disinfection of medical devices,
    • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
  2. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.



2. What is the Medical Device Establishment Licensing (MDEL) ?

MDEL is a licensing system for medical devices establishments in Saudi Arabia. It is a web based system where all applications shall be applied online. To be able to apply For MDEL ,the applicant has to be registered in Medical Devices National Registry (MDNR).
MDEL System contains two parts Establishment license (importer / Distributer) and authorised representative license.
In the importer / Distributer application MDEL system consists of four sections:
  1. Section A: Company Details.
  2. Section B: Authorized Contact Person.
  3. Section C: Manufactures & Authorized Representatives.
  4. Section D: Questionnaire Form.

In the authorised representative application MDEL system consists of three sections:
  1. Section A: Company Details.
  2. Section B: Authorized Contact Person.
  3. Section C: Manufacturers and Device Categories





3. Who Should Enroll ?

Parties subjected to establishment licensing:
  1. Importer, and any authorized representative acting as importer.
  2. All distributors, local manufacturers and authorized representatives involved in device distribution.
  3. Authorized Representatives within the KSA who has received a written mandate from the manufacturer to act on his behalf.
Note: Healthcare facilities that importing devices for their own use only are not required to be licensed.




4. How To Enroll ?

Prior to applying for MDEL, the applicant must have a MDNR number, which is unique to each establishment. the applicant can use the username and password of MDNR Account to logon into the MDEL.

The application shall be made online by using the MDEL online forms and must be accompanied by relevant supporting documents as required.

Enrollment is online and relevant information will be required. The system consists of Five main steps, namely;
Step 1: Logging on using your MDNR username and password.
Step 2: Based on the Establishment Activities ,the applicant shall select one of three options Importer, Distributer, or Both. Applicant should complete the relevant application.
Step 3: The applicant shall complete the questionnaire and upload the required documents, when there is no documents available, a brief description is must be provided in each section.
Step 4: Applicant ought to fill the attestation and the declaration parts so that the application can be submitted.
Step 5: An establishment classification will be determined and a payment request will be sent to the applicant through Email. After payment, the applicant shall login and submit it online.

As for Authorized Representatives applicant the system consists of three main steps, namely:
Step 1: The applicant shall complete the manufacturer information and upload the required documents.
Step 2: Applicant ought to fill the attestation and the declaration parts so that the application can be submitted.
Step 3: Based on the mandates the payment will be determined and a request will be sent to the applicant through Email. After payment, the applicant shall login and submit it online.

After the applicant fulfill all SFDA requirements a license is issued based on the establishment activities and sent to the applicant by express courier.


 
 
 
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