What is the 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:

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 e.g. disinfection substances , etc
  • inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process e.g. prescription eye glasses , aids for disabled/handicapped people, etc
  • 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;
    and 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.

     

  What is the National Center for Medical Devices Reporting (NCMDR)?

 

 

NCMDR is devoted to receive the technical problem reports and feedback information about any medical devices malfunction from hospitals and healthcare facilities all around KSA, studying them and working together with manufacturers and suppliers to take the right action and assuring the proper safe performance.
The center also aims to cooperate with the other international problem reporting centers to exchange reports received about medical devices used anywhere. Medical Devices Sector has membership of AHWP which works closely with Global Harmonization Task Force (GHTF).

 

  What is a Recall?

 

 

A recall is an action taken to address a problem with a medical device that violates SFDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall doesn’t always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.
Examples of the types of actions that may be considered recalls:
           Inspecting the device for problems.
           Repairing the device.
           Calibrating and adjusting settings on the device.
           Re-labeling the device.
           Destroying device.

 

           Notifying patients of a problem.

 

  What does accessory means?

  •  ‘Accessory’ means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose

  What does label mean?

 

    ‘Labeling’ means written, printed or graphic matter
    A.    Affixed to a medical device or any of its containers or wrappers.
    B.     Information accompanying a medical device, related to identification, technical description.
    C.     Information accompanying a medical device, related to its use, but excluding shipping documents.

  What is the Medical Devices National Registry (MDNR) ?

 

MDNR is an enrollment scheme for medical devices establishments, manufacturers, agents and suppliers in Saudi Arabia. It is a web-based enrollment system. All applications shall be made on-line. It consists of 2 parts. Part 1 is an account creation. Part 2 requests for information pertaining to medical devices establishments, manufacturers, agents and suppliers with respect to company profile, person responsible, medical devices particulars and pre and post-market details.

 

MDNR is not an approval system. Assignment of submission number and Registry number does not in any way constitute an admission or agreement by the SFDA to denote approval of an establishment and its products.

 

  What is the given time to pay the MDMA application fee after requesting payment by SFDA?

 

    The requested payment for MDMA application must be made within 30 calendar days.
      How can an Authorized representative (AR) update his/her information?
    Any update occur to submitted information for an Establishment or the authorized person needs to be carried out through the MDNR system.

  Why do we need to submit the Authorized representative (AR) agreement to SFDA in annual basis ?

 

    As per Article Seventeen, Chapter five of the Medical Devices Interim Regulation which states “The SFDA shall issue the applicant with an establishment license that is renewable annually when it determines that the application meets the requirements of the Interim Regulation.” However, the Medical Devices Sector is working towards having the AR license valid for more than a year.

  Does the AR need to list all of the products when he applies for MDMA?

 

Only the products which will be marketed in Saudi Arabia but the bundling criteria must be considered in each application.

 

  Can the Authorized representatives (AR) submit more than one mandate at the same time?

 

 
Yes  they can. Also, new  applications can be submitted while others are understudy.

  Why do we need to apply for the Medical Devices importing License (MDIL) for the same product every time?

 

    Since the lot/batch number, expiry date and the quantity shipped are different for each shipment then it is necessary to get an import permit every time.

  Under what category does medical software fall ?

 

It falls under Medical software category (category 17) which already has been added to the online system.

 

  What is the minimum agreement period between the Authorized representative (AR) and the manufacturer?

 

 
The validity of establishment license is one year and consequently the validity of Authorized Representative Agreement shall be at least a year effective. However, for renewal applications, agreements that has validity of 3 months or above is acceptable.
 
Therefore, three months are the minimum period to be accepted by SFDA.

  If two sub manufacturers make the same product for the same legal manufacture, how to apply for MDMA ?

 

MDMA will be issued to the legal manufacturer based on the name & address of the legal manufacturer which mentioned in the original approval and it must match with all related documents for example, Label & Instruction for use (IFU).

 

  If there are different classes of accessories belong to a medical device, can it be listed in one application?

 

Yes, if  the accessory has been manufactured for  the main medical device.

 

  Do we need to inform the SFDA if the reference number of cables or other accessories has changed?

 

The applicant must indicate of any changes  to the submitted MDMA application.

 

  Can we change or add points on the attestation?

 

 

Attestations found in Medical Devices Sector web-page are not changeable.
  Can a manufacturer list the bundling products and send it to the SFDA for approval before submitting in MDMA?
SFDA need to study the provided  technical file through MDMA application. Therefore, the applicant must consider bundling criteria(Same purposes, technical performance and classification).
 For more information refer to Guidance on Marketing Authorization Procedures.

 

http://www.sfda.gov.sa/en/medicaldevices/regulations/DocLib/MDS-G5.pdf

 

  Does the responsibility of the Statement for KSA Environmental Factors ends when the product enters Saudi Arabia ?

 

 
The instructions for use shall provide information on any measures taken to accommodate the specific non electrical environmental and/or conditions of use encountered in the KSA , such as (a) local operating temperature and humidity conditions and (b) the level of protection of the devices against electro-magnetic disturbances, when applicable.
The applicant is required to provide a statement confirming that the devices will maintain its specified performance when subject to the environmental factors that may be encountered within the KSA.

  What can the manufacturer provide when the product has no market literature ?

 

 
Where the manufacturer has already prepared advertising and marketing material, intended to be used in the KSA, at the time of application, a copy shall be provided to the SFDA.
As part of the requirements specific to the SFDA, electronic copies of any advertising or marketing material that the manufacturer intends to use in the KSA after the medical device has been authorized to be placed on the market are submitted to the SFDA through the MDMA.
Marketing material includes, for example, product brochures, information on clinical performance, and publications from technical magazines.
Advertising material includes, for example, written material, information available on the internet television or radio, exhibition material and the like, and information available in electronic form.
Advertising and marketing material may be prepared for professional persons, lay persons or both.

  Should the manufacturer provide a full audit report or a summarized one?

SFDA requests the audit report in order to confirm that the EC Certificates are still valid. Therefore, full audit report OR summarized audit report OR a letter from the notified body is accepted AS LONG AS  it provides the needed information to confirm that the EC Certificates are still valid.

  What is the acceptable timeframe of the audit report to be approved by SFDA?

 

The audit report should not be less than 1 year old.

  What is the acceptable expiry date of the CE mark to be approved by SFDA?

 

Three months after the SFDA final  decision.

 

  When is the medical software considered as a medical device ?

 

 

If the software has been classified as a medical device in one or more of the following countries USA, Canada, EU, Japan and

 

Australia , then it is a medical device.

 

  what are the designated ports of Entries for Medical Devices?

 
Out of twenty seven ports of entries in the kingdom of Saudi Arabia, Medical Devices sector is currently located in nine ports only. The ports are listed as follows:
Area
Code
DPOE
Riyadh
RAP
King Khalid international Airport
Riyadh
RDP
Dry Port
Jeddah
JSP
King Abdulaziz International Airport
Jeddah
JAP
Jeddah Islamic Sea port
Dammam
DSP
King Fahad International airport
Dammam
DAP
King Abdulaziz sea port
Dammam
DBP
King Fahad causeway- Dammam
Batha
QBP
Batha Port – Batha
Qurayyat
BBP
Hadithah Port
 

  What are the items that needs to have temperature indicators?

 

 

- In Vitro Medical Devices.

 

- Non Medical Reagents and Indicators.

 

  Does the manufacturer need to notify SFDA about all of the reportable and not reportable adverse events?

 

 

Manufacturer is required to notify SFDA/NCMDR of all reportable adverse events only .
For more information please refer to the SFDA-Medical Devices Sector websitehttp://www.sfda.gov.sa/en/medicaldevices/Pages/default.aspx
  What should the manufacturer do if the recalled device owner refuses to cooperate with the correction plan?

 

The establishment by itself or through its authorized representative is responsible for  communication with healthcare facility  in order to execute the recommended corrective action and shall take all the necessary measure , such refusal shall not waived the responsibility be all means.