Sudan - Registration of medical device and In Vitro devices (IVDs)

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Procedure

How to apply :
In-Person :

1. Applicants gather all the required documents and visit the National medicine and Poison Broad (NMPB)
2. Request for an application form (Medical Device Establishments Registration (MDER) fill it accurately, attach all the requirements and submit them to the attending official
3. The application will be investigated, verified and process if all the information are In order and the all required fees paid ,you will be issued with the certificate of registration by a Delegated Authority, for the National Medicine and Poisons Board within 4 months

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Required Documents

• General requirements:
  
  • The manufacturing plant should be registered within the NMPB records
  • Accurate filled application form
  • The prescribe fee
• Specific Requirements
  
  

Registration requirement of Human medical device

• Submit one of the following certificate
• EC Certificate compatible with the classification of medical device
  • US food and drugs administration (FDA approval)
  • Certificate registration in a country with a stringent regulatory authority (IMDRF countries)
• Submit medical device description, specification and intended use
• Submit internal and external label of the medical device
  
  

Registration requirements of veterinary medical device:

• Submit one of the following certificate
  • Free sale certificate
  • Certificate for registration in a country with the regulatory authority (International Medical Device Regulatory Forum (IMDRF) Countries)
• Submit medical device description, specification and intended use
• Submit internal and external label of the medical device (the label must clearly state that the medical device is for veterinary use only)
  
  

NOTE :

• All documents should be submitted in English or Arabic
• Please do not submit duplicate applications.

Office Locations & Contacts

Federal Ministry of Health (FMOH):
Physical address
National Ministry of Health,Osman digna street with Nile avenue, Sudan,Khartoum,
Postal address
National Ministry of Health,Osman digna street with Nile avenue P O Box 303 Zip code 1111, Sudan,Khartoum,
Telephone +249917047000

National Medicines and Poison Board :
Website: National Medicines and Poison Board?
E-Mail: [email protected]
Telephone No: 0155880271
Ministry of Physical address: Alklakla ST, Abu Hamama Station, South Khartoum (Sudan)
PO BOX 293
Email address: [email protected]
Phone +249-155-660723

Eligibility

• The manufacturer of the medical device, or
• The authorized representative of the foreign manufacturer, based in Sudan, or
• authorized representative agent or distributer of the foreign manufacturer

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

The licences is valid for one year and renewable thereafter, unless its evoke or suspended by the National Medicines and Poison Board

Documents to Use

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Sample Documents

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Processing Time

Within 4 months, if all the information are in order.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external   websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Medical Device Classification::

• It is the responsibility of the applicant to obtain information on classification of medical devices and to ascertain that the device indicated on the application has been classified as a medical device. For information on medical device classification, please refer to the Guidelines for Medical Device Registration or Guidelines for IVD medical device Registration
• It’s an applicant’s responsibility to determine if they require an MDER. If it is determined that the products are not classified as medical devices or IVD Medical device, the fees associated for the examination of previously submitted MDER applications will not be refunded.

Required Information

• Applicant particular
• Manufacturer particular
• Agent or representative particular
• Premises Address of the manufactory
• medical device particular

Need for the Document

The registration of medical device by the National medicine and Poison Broad (NMPB) is to ensures that all medical devices distributed, imported or exported in or out of Sudan are of the benefit of the consumers and general public at a reasonable market price

Information which might help

Enter other informations which might help.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

National Medicines and Poison Board

Others

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