Overview on Medical Device registration and Maintenance of Medical Devices in Sudan

Regulatory Authority

National medicine and Poison Broad (NMPB)

The National Medicines and Poisons Board (NMPB) is responsible for registering medical products, including medicines and medical equipment. However, there is a duplication of responsibilities between the NMPB and the Sudanese Standards and Metrology Organization (SSMO), which has the mandate to define and adopt standards for imported or built commodities in Sudan.

The committee dedicated to Medical Device Standards is working on adapting internationally recognized standards and publishing them as official documents. The Sudan Atomic Energy Commission (SAEC) plays a crucial role in providing medical device assessment and monitoring services to both public and private healthcare sectors. 

SAEC focuses on servicing and controlling radiation therapy equipment but also plays a regulatory role. The biomedical engineering department at the Federal Ministry of Health (FMOH) is responsible for policymaking, planning medical devices, and supporting the identification of equipment requirements for new hospitals.

The department also leads the FMOH in creating guidelines and SOPs for medical devices, including product selection, specifications, and procurement justifications.

Link for Regulatory Authority 

http://www.nmpb.gov.sd/en/

Local Regulation

Health Technology Management Policy (Medical Devices)

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

• The manufacturing plants should be registered within the NMPB records.
• Applicants gather all the required documents and visit the National Medicine and Poison Broad (NMPB).
• Request for an application form (Medical Device Establishments Registration (MDER)) fill it out accurately, attach all the requirements and submit them to the attending official.
• The application will be investigated, verified and process if all the information is in order and all required fees paid, then the certificate of registration will be issued by a Delegated Authority, for the National Medicine and Poisons Board within 4 months.

Documents Required for Sudan Medical Device Registration

• • Accurately filled application form.
  • The prescribe fee payment proof.
  • Submit one of the following certificates
    • 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

https://www.nmpb.gov.sd/drug/Requirements%20for%20the%20registration%20of%20Medical%20Devices%20(Human%20and%20Veterinary).pdf

Registration Timeline

Around 4 months

License Validity and Renewal

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

Special Labelling Requirements

Labelling should be submitted in English or Arabic

Additional Comments

All documents should be submitted in English or Arabic

Maintenance

The National Medical Devices and Systems Foundation (NMSF) is responsible for preventive and corrective maintenance of medical devices, computer systems, and software. It provides after-sales service by trained technicians visiting health facilities, and recruits BMEs to assist hospital management in identifying equipment needs and placing orders for new equipment procurement. 

The NMSF trains technicians and provides specialized tools to those trained. If in-house or locally available engineers or technicians are unavailable, the NMSF provides services to hospitals. The strategy is to establish workshops for medical device maintenance in certain states, supporting State Ministries of Health and health facilities. 

During warranty periods, maintenance is done by manufacturers through local agents, and there are no private workshops for medical device maintenance.

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: info@omcmedical.co.uk