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General rules to applicants for registration of medical and laboratory diagnostic equipment and reagents:
Applicants should be:
Holder of a valid wholesales license (License A for medical devices) and an agency agreement with the manufacturer.
Applicant shall register the manufacturing plants in NMPB first.
The applicant should fill in the prescribed application form and should not overlook any required information in any part, signed by responsible person and stamped.
The applicant should present with the application form, the specified documents. Documents should be in English and /or Arabic languages.
The applicant should pay the prescribed registration fees and attach the receipt to the cover letter.
Any incomplete or incorrect documents will not be accepted.
Registration documents as following:
Application form with a cover letter.
Original Free sale certificate stamped by the responsible party in the country of origin.
The medical consumable must conform to standards of agencies such as FDA, EC or must have a summary technical documentation (STED).
Provision of a complete declaration of conformity form, signed by responsible person and stamped available on the website of NMPB.
Full description of technical specifications and intended use of the medical equipment, reagents and solutions.
Certificate of analysis from the manufacturer.
A mock up label of the medical laboratory equipment and reagent.
Chemicals are subjected to Importation regulations and requirements only.
Laboratory diagnostic equipment (IVD)
accessories are subjected to Importation regulations and requirements.
Po box 218, Khartoum, Sudan
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